| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| [NCT01315093] | Phase 2/Phase 3 | 50 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients. [NCT01228292] | Phase 4 | 250 participants (Anticipated) | Interventional | 2011-01-31 | Not yet recruiting |
| Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins [NCT01200914] | | 14 participants (Actual) | Interventional | 2011-01-31 | Terminated(stopped due to poor recruitment) |
| A Prospective Randomized Pilot Trial on Safety and Feasibility of Argatroban as Anticoagulant in Patients With Extracorporeal Membrane Oxygenation (ECMO) [NCT05226442] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2021-12-01 | Recruiting |
| A Randomized Controlled Crossover Trial of Two Different Central Venous Catheter Flushing Schemes in Pediatric Hematology and Oncology Patients in Alberta, Canada [NCT01343680] | Phase 3 | 2 participants (Actual) | Interventional | 2011-04-30 | Terminated(stopped due to Poor patient accrual) |
| [NCT01072955] | Phase 3 | 104 participants (Anticipated) | Interventional | 2010-04-30 | Recruiting |
| Efficacy and Safety of Alternating Systemic and Hepatic Artery Infusion Therapy Versus Systemic Chemotherapy Alone As Adjuvant Treatment After Resection of Liver Metastases From Colorectal Cancer: A Randomized, Parallel-Group, Open-Labelled, Active-Contro [NCT02529774] | Phase 2/Phase 3 | 432 participants (Anticipated) | Interventional | 2015-09-30 | Not yet recruiting |
| Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial [NCT03633994] | Phase 2 | 104 participants (Anticipated) | Interventional | 2018-08-20 | Recruiting |
| the Effect of Unfractionated Heparin in Treatment of IVF-ET Failure [NCT01214772] | Phase 4 | 86 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial. [NCT01124058] | Phase 1 | 39 participants (Actual) | Interventional | 2010-07-31 | Completed |
| HepZero:Heparin Free Dialysis With Evodial: A Prospective Multicenter, Open, Randomized, Controlled Clinical Study With Parallel Groups [NCT01318486] | | 265 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Randomized Control Trial of Unfractionated Heparin Thromboprophylaxis Dosing for Antepartum Hospitalizations [NCT04635839] | Phase 4 | 46 participants (Actual) | Interventional | 2020-12-15 | Completed |
| Heparin Dose Reduction During Hemodialysis With the Gambro Revaclear and Revaclear MAX Hemodialyzers: Pilot Study I and II [NCT01181544] | | 5 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized Trial [NCT05223244] | Phase 4 | 83 participants (Actual) | Interventional | 2011-10-01 | Completed |
| A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure [NCT04389840] | Phase 2/Phase 3 | 27 participants (Actual) | Interventional | 2020-07-08 | Terminated(stopped due to Due to improvement in the Coronavirus Disease 2019 (COVID-19) pandemic and low subject accrual.) |
| Single Center Open Label Randomized Study Evaluating Safety and Efficacy of Subcutaneous Heparin Compared to Standard of Care Intravenous Heparin Anticoagulation During Veno-venous Extracorporeal Membrane Oxygenation for Respiratory Failure [NCT04496362] | Phase 4 | 100 participants (Anticipated) | Interventional | 2018-10-10 | Recruiting |
| Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism [NCT03988842] | Phase 4 | 4 participants (Actual) | Interventional | 2019-07-25 | Terminated(stopped due to COVID-19 pandemic) |
| Standard vs High Dose of Unfractionated Heparin in the Incidence of Radial Artery Occlusion (DEFINITION) Trial. [NCT04561648] | | 1,988 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| Tissue Plasminogen Activator Dwells to Reduce Catheter-associated Thrombosis and Infection [NCT03672006] | Phase 2 | 20 participants (Actual) | Interventional | 2019-04-22 | Completed |
| A Randomized Controlled Trial for PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER Trial) [NCT03006562] | Phase 4 | 501 participants (Actual) | Interventional | 2017-07-01 | Terminated(stopped due to Early stopping point based on 2nd interim analysis (planned per protocol)) |
| Comparison of the Effecta and Drawbacks of Heparin Versus Hirudin Drugs in Haemodialysis Patients in Assiut University Hospitals [NCT06112262] | Early Phase 1 | 98 participants (Anticipated) | Interventional | 2023-12-20 | Not yet recruiting |
| Efficacy of a Single Dose Intravenous Heparin During Diagnostic Angiography in Reducing Sheath-clot Formation: A Randomized Controlled Trial [NCT01260519] | Phase 3 | 304 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath: Randomized Controlled Trial [NCT05707936] | | 192 participants (Anticipated) | Interventional | 2023-02-01 | Not yet recruiting |
| Systemic Anticoagulation With Full Dose Low Molecular Weight Heparin (LMWH) Vs. Prophylactic or Intermediate Dose LMWH in High Risk COVID-19 Patients (HEP-COVID Trial) [NCT04401293] | Phase 3 | 257 participants (Actual) | Interventional | 2020-04-26 | Completed |
| Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction [NCT02448550] | Phase 3 | 250 participants (Actual) | Interventional | 2015-05-31 | Terminated |
| Effect of Low-Molecular-Weight-Heparin (LMWH) on Pregnancy Outcome in Women With Multiple Failures of IVF-ET [NCT03701750] | Phase 4 | 240 participants (Anticipated) | Interventional | 2018-11-01 | Recruiting |
| A Comparison of Dilute Unfractionated Heparin and Standard Concentrated Unfractionated Heparin Protocols for Anticoagulation of the Extra-corporeal Circuit During Continuous Renal Replacement Therapy in the ICU [NCT01318811] | Phase 4 | 12 participants (Actual) | Interventional | 2011-03-31 | Terminated(stopped due to lack of recruitment) |
| Reprometabolic Syndrome Mediates Subfertility in Obesity [NCT02653092] | | 84 participants (Actual) | Interventional | 2016-06-30 | Completed |
| Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management [NCT03182218] | | 1,100 participants (Actual) | Observational | 2015-02-28 | Completed |
| Performance and Safety of the Roxwood CenterCross™ CenterCross™ Ultra, CenterCross™ Ultra LV and MultiCross™ Catheters and MicroCross™ MicroCatheter in Native Coronary and Peripheral Arteries With a Stenotic Lesion or Chronic Total Occlusion (CTO) [NCT04059536] | | 0 participants (Actual) | Observational | 2019-10-31 | Withdrawn(stopped due to Sponsor decision) |
| Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department [NCT00657228] | | 0 participants (Actual) | Interventional | 2009-12-31 | Withdrawn(stopped due to Study did not start.) |
| Low Molecular Weight Heparin (Enoxaparin Sodium) and Standard Unfractionated Heparin for Hemodialysis Anticoagulation [NCT01356615] | | 27 participants (Actual) | Interventional | 2011-03-31 | Completed |
| A Three-arm, Multicenter, Open-label Randomized Controlled Trial of Hydroxychloroquine and Low-dose Prednisone on Recurrent Spontaneous Abortion With Undifferentiated Connective Tissue Diseases: Protocol for the Immunosuppressant Regimens for Living FEtus [NCT03671174] | | 420 participants (Anticipated) | Interventional | 2019-08-02 | Recruiting |
| Bivalirudin With Prolonged Full Dose Infusion Versus Heparin Alone During: a Multicenter, Randomized, Open-label Trial [NCT03822975] | | 6,016 participants (Actual) | Interventional | 2019-02-14 | Active, not recruiting |
| An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events [NCT03395639] | Phase 3 | 168 participants (Actual) | Interventional | 2018-05-15 | Completed |
| Comparison of Biocompatibility of Plasmapheresis Procedures With Citrate and Heparin Anticoagulation [NCT05191290] | Phase 4 | 15 participants (Actual) | Interventional | 2022-01-21 | Completed |
| Low Molecular Weight hEparin vs. Aspirin Post-partum [NCT05058924] | | 50 participants (Anticipated) | Interventional | 2021-08-29 | Recruiting |
| A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembol [NCT02981472] | Phase 2 | 192 participants (Actual) | Interventional | 2017-01-19 | Completed |
| Low-Dose Tenecteplase in Covid-19 Patients With Acute Pulmonary Embolism: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT04558125] | Phase 4 | 2 participants (Actual) | Interventional | 2020-09-08 | Terminated(stopped due to Identification of eligible patients was slower than anticipated.) |
| Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation [NCT05774691] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2023-11-01 | Recruiting |
| Safety and Efficacy of Switching From Direct Oral Anticoagulants to Low Molecular Weight Heparin in Cancer Patients With Atrial Fibrillation During Antineoplastic Therapy [NCT04508855] | | 240 participants (Anticipated) | Observational | 2020-08-01 | Recruiting |
| Postprandial Fatty Acid Metabolism in Subjects With Lipoprotein Lipase Deficiency [NCT04227678] | | 16 participants (Anticipated) | Interventional | 2019-12-09 | Recruiting |
| Randomized Control Trial to Assessed the Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Severe Sepsis [NCT02135770] | Phase 3 | 115 participants (Actual) | Interventional | 2013-01-31 | Completed |
| A Randomized, Open-Label Trial of Therapeutic Anticoagulation in COVID-19 Patients With an Elevated D-Dimer [NCT04377997] | Phase 2 | 300 participants (Anticipated) | Interventional | 2020-05-15 | Recruiting |
| Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure [NCT01346215] | Phase 3 | 132 participants (Anticipated) | Interventional | 2011-10-31 | Not yet recruiting |
| Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit [NCT03562754] | | 60 participants (Actual) | Interventional | 2019-03-11 | Completed |
| Anticoagulant Effect and Reversal of Hepalean Compared With PPC Heparin in Patients Undergoing Cardiopulmonary Bypass: a Pilot Randomized Trial [NCT01343381] | Phase 4 | 21 participants (Actual) | Interventional | 2011-06-30 | Completed |
| A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fractur [NCT01352039] | Phase 3 | 544 participants (Actual) | Interventional | 2011-10-31 | Terminated |
| High Bolus Dose Tirofiban and Enoxaparin Provides Reduced Thrombin Generation and Inflammatory Markers in Patients With High Risk Undergoing Percutaneous Intervention [NCT00790387] | Phase 4 | 60 participants (Actual) | Interventional | 2004-06-30 | Completed |
| Prospective Randomized Pilot Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric Extracorporeal Membrane Oxygenation [NCT03318393] | Phase 4 | 30 participants (Actual) | Interventional | 2018-03-25 | Completed |
| A Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patie [NCT01356329] | Phase 3 | 150 participants (Anticipated) | Interventional | 2009-10-31 | Suspended(stopped due to Difficulty in enrolling patients) |
| Assessing Safety and Efficacy of Lean Body Weight-based Intravenous Heparin Dosing in Obese/Morbidly Obese Patients. A Pilot Study [NCT01363193] | | 100 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting |
| Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients With Hypersplenism After Laparoscopic Splenectomy [NCT02238444] | Phase 4 | 60 participants (Anticipated) | Interventional | 2014-09-01 | Recruiting |
| Heparin AnticoaguLation to Improve Outcomes in Septic Shock: The HALO International Phase II RCT [NCT03378466] | Phase 2 | 178 participants (Actual) | Interventional | 2018-03-12 | Terminated(stopped due to infeasible to continue due-to inability to recruit during the COVID-19 pandemic and grants coming to an end.) |
| A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dociparstat Sodium in Combination With Standard Chemotherapy for the Treatment of Newly Diagnosed Acute Myeloid Leukemia [NCT04571645] | Phase 3 | 9 participants (Actual) | Interventional | 2021-04-30 | Active, not recruiting |
| Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism [NCT01164046] | Phase 3 | 56 participants (Actual) | Interventional | 2010-08-31 | Terminated(stopped due to Due to slow inclusion of patients) |
| Low Dose Catheter Directed Thrombolysis for Acute Intermediary-high Risk Pulmonary Embolism [NCT03854266] | Phase 2 | 60 participants (Anticipated) | Interventional | 2020-03-10 | Recruiting |
| Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation: an Open Label, Parallel Group Randomized Pilot Study (BIV-ECMO2) [NCT03965208] | Phase 4 | 34 participants (Anticipated) | Interventional | 2019-05-23 | Recruiting |
| An Open-label, Randomized, Single Center, Crossover Study in Healthy Participants to Assess Lipoprotein Lipase Activity and Levels, and Triglyceride Levels After Heparin Exposure, in Both Fasted and Postprandial State [NCT05178550] | Early Phase 1 | 12 participants (Actual) | Interventional | 2021-12-17 | Completed |
| A Phase IIIb-IV, Randomised, Open Label Trial on Efficacy and Safety of 2 Parallel Groups: Full Dose Tenecteplase Combined With Unfractionated Heparin or Enoxaparin in Acute Myocardial Infarction in the Prehospital Setting (ASSENT 3 Plus) ASSENT 3 Plus Wa [NCT02181998] | Phase 3 | 1,606 participants (Actual) | Interventional | 2000-07-31 | Completed |
| B-Lymphocyte Immunotherapy in Islet Transplantation: Single Subject Modification to Calcineurin-Inhibitor Based Immunosuppression for Initial Islet Graft (CIT-0501) [NCT01049633] | | 0 participants | Expanded Access | | No longer available |
| Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team [NCT05512702] | | 100 participants (Anticipated) | Observational | 2022-06-03 | Recruiting |
| A Pilot Study on the Influence of an Optimized Heparin Regimen on the Hemostatic Environment Downstream From the Surgical Clamp in Major Vascular Surgery. [NCT02477072] | | 32 participants (Actual) | Interventional | 2015-09-30 | Completed |
| Multi-center，Single Blind，Prospective Randomized Controlled Trial of Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation [NCT03306836] | | 408 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| Intermediate-dose Versus Standard Prophylactic Anticoagulation In cRitically-ill pATIents With COVID-19: An opeN Label Randomized Controlled Trial---A Randomized Trial of Atorvastatin vs. Placebo In Critically-ill Patients With COVID-19 [NCT04486508] | Phase 3 | 600 participants (Actual) | Interventional | 2020-07-30 | Completed |
| Sildenafil Versus Low Molecular Weight Heparin in Fetal Growth Restriction Treatment [NCT03230162] | Phase 3 | 100 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
| A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Tolerability of C1 Inhibitor (CINRYZE) as a Donor Pre-treatment Strategy in Brain Dead Donors Who Meet a Kidney Donor Risk Index (KDRI) Above 60% [NCT02435732] | Phase 1 | 72 participants (Anticipated) | Interventional | 2020-12-31 | Not yet recruiting |
| [NCT02423642] | | 30 participants (Actual) | Interventional | 2013-07-31 | Completed |
| A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis [NCT03000673] | Phase 1/Phase 2 | 32 participants (Actual) | Interventional | 2017-05-23 | Completed |
| Acute Mesenteric Venous Thrombosis.. in Assiut University Hospital Management Controversies [NCT03483207] | | 30 participants (Anticipated) | Interventional | 2018-04-01 | Not yet recruiting |
| Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery [NCT03302195] | | 410 participants (Anticipated) | Interventional | 2015-08-21 | Recruiting |
| Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial [NCT03772613] | Phase 2 | 180 participants (Actual) | Interventional | 2019-02-08 | Completed |
| Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Subcutaneous Use in Healthy Participants [NCT03113084] | Phase 1 | 38 participants (Anticipated) | Interventional | 2022-08-20 | Suspended(stopped due to Delay in the R&D stage) |
| The Effect of Heparinization Due to LBW in Cardiac Surgery [NCT03113708] | Phase 4 | 50 participants (Anticipated) | Interventional | 2017-04-30 | Not yet recruiting |
| Reduced Anticoagulation Targets in ECLS (RATE) [NCT04536272] | Phase 3 | 330 participants (Anticipated) | Interventional | 2020-10-01 | Recruiting |
| Phase I Study With Pharmacodynamic Determination of Unfractionated Heparin of Porcine Origin of the Company União Química of Intravenous Use in Healthy Participants [NCT03125187] | Phase 1 | 24 participants (Anticipated) | Interventional | 2021-02-20 | Suspended(stopped due to Delay in the R&D stage) |
| Comparisons of Two Low-density Lipoprotein Apheresis Systems in Patients With Homozygous Familial Hypercholesterolemia [NCT02286596] | | 9 participants (Actual) | Observational | 2013-04-30 | Completed |
| A Randomised, Placebo-controlled Trial to Investigate the Efficacy of Intranasal Heparin Treatment to Reduce Transmission of SARS-CoV-2 Infection and COVID 19 Disease Among Household Contacts of SARS-CoV-2+ Adults and Children [NCT05204550] | Phase 2/Phase 3 | 1,100 participants (Anticipated) | Interventional | 2023-01-30 | Recruiting |
| Pregnancy Outcomes in Women With Unexplained Recurrent Pregnancy Loss Treated With Low Dose Aspirin and Unfractionated Heparin [NCT02144064] | Phase 3 | 200 participants (Anticipated) | Interventional | 2019-06-23 | Recruiting |
| A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome [NCT00932100] | Phase 2 | 640 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Taurolidine Citrate and Unfractionated Heparin Combination Versus Unfractionated Heparin Alone in Prevention of Inflammation in Hemodialysis Catheters. [NCT03539718] | Phase 4 | 60 participants (Anticipated) | Interventional | 2018-05-15 | Recruiting |
| The Independent Effect of Level of Kidney Function and Body Composition On Establishing HDL Cholesterol Levels [NCT02755818] | | 50 participants (Actual) | Observational | 2008-10-22 | Terminated(stopped due to insufficient patients with CKD willing to be injected with heparin) |
| Hamburg Edoxaban for Anticoagulation in COVID-19 Study [NCT04542408] | Phase 3 | 140 participants (Actual) | Interventional | 2020-11-12 | Completed |
| Evaluate the Efficacy and Safety of Various Treatment Schemes for Severe Fever With Thrombocytopenia Syndrome：a Prospective, Multicenter, Non-randomized Controlled Intervention Study [NCT05604859] | Phase 4 | 350 participants (Anticipated) | Interventional | 2022-08-19 | Recruiting |
| Efficacy of Nebulized Heparin and Salbutamol in Mechanically Ventilated Patients With Acute Exacerbation Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial [NCT03333395] | Phase 4 | 60 participants (Actual) | Interventional | 2017-02-01 | Completed |
| Role of Nebulized Heparin in Non-severe and Severe Covid-19 Patients Admitted to COVID Complex LRH, MTI: A Randomized Controlled Trial [NCT05255848] | Phase 2/Phase 3 | 180 participants (Anticipated) | Interventional | 2022-06-20 | Not yet recruiting |
| BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO) [NCT05959252] | Phase 2 | 80 participants (Anticipated) | Interventional | 2024-01-01 | Not yet recruiting |
| Evaluation of the Efficacy of Anisodamine Hydrobromide Combined With Heparin in the Treatment of Patients With Critical Infection [NCT05634057] | | 782 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2 O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Patients Receiving Induction or Consolidation Therapy for Acute Myeloid Leukemia [NCT02056782] | Phase 1 | 12 participants (Actual) | Interventional | 2013-12-31 | Completed |
| D-dimer to Improve Anticoagulation Management in Adult Patients Supported With Extracorporeal Membrane Oxygenation: a Prospective Cohort Study [NCT03261284] | | 300 participants (Anticipated) | Interventional | 2019-03-01 | Active, not recruiting |
| Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial [NCT04466670] | Phase 2 | 379 participants (Anticipated) | Interventional | 2020-07-11 | Recruiting |
| Feasibility to Stop Perdialytic Heparin Therapy in Hemodialysed Patients With HeprAN ™ Membrane and Treated by Long-term Anticoagulation With VKA [NCT04462614] | | 49 participants (Anticipated) | Interventional | 2020-08-31 | Not yet recruiting |
| STUDIO CLINICO RANDOMIZZATO SULL'UTILIZZO DI EPARINA PER LA PROFILASSI DELLA TROMBOFLEBITE DA CATETERE VENOSO PERIFERICO [NCT01131754] | Phase 3 | 214 participants (Actual) | Interventional | 2007-06-30 | Completed |
| Comparative Effectiveness of Heparin Versus Normal Saline in Maintaining Patency of Peripherally Inserted Central Catheter Lines in Oncology Inpatients [NCT05029596] | Early Phase 1 | 142 participants (Actual) | Interventional | 2020-02-12 | Completed |
| Comparison of Analgesia With Fentanyl and Morphine on Platelet Inhibition After Pre-hospital Ticagrelor Administration in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention [NCT02531165] | | 38 participants (Actual) | Interventional | 2015-09-30 | Completed |
| Citrasate® Effect On Heparin N Requirements During Hemodialysis Treatment: A Phase IV,Study to Investigate the Effects of Citrasate on Heparin N Requirements During Hemodialysis Treatment in Subjects Maintained on Thrice Weekly Hemodialysis [NCT01092455] | | 300 participants (Anticipated) | Observational | 2009-12-31 | Completed |
| Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy [NCT01076764] | Phase 3 | 13,220 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Pathogenesis, Diagnosis, Management and Outcome of Hemostatic Complications in Hematopoietic Stem Cell Transplantation: A Prospective Study [NCT02281240] | | 200 participants (Anticipated) | Observational | 2014-12-31 | Recruiting |
| Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial [NCT01220245] | | 129 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Subcutaneous Administration in Healthy Subjects [NCT05788913] | Phase 1 | 68 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacodynamics of an Unfractionated Heparin Compared to Heparin Sodium Injection, USP (Comparator) After Intravenous Administration in Healthy Subjects [NCT05788900] | Phase 1 | 68 participants (Anticipated) | Interventional | 2023-06-01 | Not yet recruiting |
| "Comparative Study of Two Haemodialyzers VIE 2.1 Versus EVODIAL2.2 in a Strategy of Heparin-free Haemodialysis (HFH)" [NCT01221337] | | 32 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Safety of Heparin Anticoagulation for Prevention of Death in Patients With Septic Shock. [NCT01234285] | Phase 2 | 0 participants (Actual) | Interventional | 2010-12-31 | Withdrawn(stopped due to Sara Cheng, MD has left the Univ. of Colorado and the study has been closed.) |
| Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS) [NCT04355728] | Phase 1/Phase 2 | 24 participants (Actual) | Interventional | 2020-04-25 | Completed |
| Clinical Trial Program of a Medical Instrument Product [NCT01157455] | Phase 4 | 1,900 participants (Anticipated) | Interventional | 2010-05-31 | Recruiting |
| Bivalirudin vs Heparin in Elderly Patients With Acute ST-segment Elevation Myocardial Infarction Undergoing Emergency Percutaneous Coronary Intervention [NCT03882775] | Phase 4 | 240 participants (Anticipated) | Interventional | 2019-01-16 | Recruiting |
| Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins [NCT01271881] | | 140 participants (Anticipated) | Interventional | 2010-10-31 | Recruiting |
| Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis (TOACT) [NCT01204333] | Phase 2/Phase 3 | 67 participants (Actual) | Interventional | 2011-09-30 | Terminated |
| A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support [NCT03707418] | Phase 1 | 0 participants (Actual) | Interventional | 2021-04-30 | Withdrawn(stopped due to unable to secure funding) |
| Randomized Comparison of Continuous and Intermittent Heparin Infusion During Catheter Ablation of Atrial Fibrillation [NCT01935557] | Phase 3 | 296 participants (Actual) | Interventional | 2012-12-31 | Completed |
| A Randomized Study Aimed at Comparing Activated Partial Thromboplastin Time and Anti-Xa Activity and in Patients Requiring Unfractionated Heparin Infusion [NCT03426982] | Phase 4 | 700 participants (Anticipated) | Interventional | 2018-03-01 | Recruiting |
| A Different Approach to Preventing Thrombosis (ADAPT): A Randomized Controlled Trial Comparing Low Molecular Weight Heparin to Acetylsalicylic Acid in Orthopedic Trauma Patients [NCT02774265] | Phase 3 | 329 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Comparison of Two Dosages of Heparin Before Extracorporeal Circulation [NCT03752437] | Phase 4 | 150 participants (Actual) | Interventional | 2019-10-01 | Completed |
| Efficacy and Local Tolerability of Topically Applied Heparin (Heparin 2,400 IU /ml Cutaneous Spray) on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis. A Multicentre, Randomized, Double-blind and P [NCT01382888] | Phase 2 | 30 participants (Actual) | Interventional | 2011-07-31 | Terminated(stopped due to The Sponsor decided to terminate the study due to the low patient recruitment.) |
| Phase 4 Study of Fixed-dose and Titration Schemes of Heparin and Protamine in Cardiopulmonary Bypass Cardiac Surgeries : Evaluation of Post-operatory Blood Loss and Transfusion Requirements [NCT01267487] | Phase 4 | 240 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure [NCT04842292] | Phase 2 | 2 participants (Actual) | Interventional | 2021-05-20 | Terminated(stopped due to Lack of enrollment) |
| Prevention of Lower Extremity Deep Venous Thrombosis in the Surgical Intensive Care Unit: a Randomized Trial Comparing Subcutaneous Heparin and Subcutaneous Enoxaparin [NCT01325779] | | 0 participants (Actual) | Interventional | 2011-03-31 | Withdrawn(stopped due to poor enrollment) |
| Influence of Acetylsalicylic Acid and Low Molecular Weight Heparins on the Incidence of Renal Hematoma of Shockwave Lithotripsy [NCT02875717] | | 500 participants (Actual) | Observational | 2009-01-31 | Completed |
| Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE) [NCT00981409] | Phase 3 | 41 participants (Actual) | Interventional | 2007-07-31 | Completed |
| Deep Venous Thrombosis. Long-Term Results After Treatment With Either Low-Molecular -Weight Heparin or Unfractionated Heparin. Examinations of the Venous System. [NCT00628576] | Phase 3 | 99 participants (Actual) | Interventional | 1993-10-31 | Completed |
| Radiation Dose in Humans From Orally Administered Tc99m-Heparin [NCT04069429] | Early Phase 1 | 8 participants (Actual) | Interventional | 2016-07-31 | Completed |
| Acute STEMI Treated With Primary Angioplasty and Intravenous 0.5 mg/kg Lovenox or UFH to Lower Ischemic and Bleeding Events [NCT00718471] | Phase 3 | 910 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Lipoprotein Lipase Enzyme Activity Assay Validation and Clinical Assessment [NCT02656095] | | 12 participants (Actual) | Observational | 2016-03-31 | Completed |
| Empirical Low Molecular Weight Heparin Administration in the Luteal Phase in Patients With Recurrent Implantation Failures: a Randomized Open Labeled Trial [NCT00750451] | | 0 participants | Interventional | 2006-01-31 | Completed |
| Effect of Anticoagulation in Reducing the Incidence of Splenic/Portal Vein Thrombosis Post-Laparoscopic Splenectomy Protocol Number: 5698 [NCT00769873] | Phase 2 | 35 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to Recruitment was slower than anticipated. Insufficient funding to expand to multi-centered trial.) |
| Comparison of Citrate and Heparin Anticoagulation During Hemodialysis With Medium Cut-off Polyarylethersulphone- Polyvinylpirrolidone (Theranova) Membrane [NCT04139525] | | 32 participants (Actual) | Interventional | 2020-09-15 | Active, not recruiting |
| Bivalirudin vs Heparin in Elderly Patients With Acute Coronary Syndrome Undergoing Elective Percutaneous Coronary Intervention [NCT04046029] | Phase 4 | 240 participants (Anticipated) | Interventional | 2019-07-08 | Recruiting |
| Efficacy of Sodium Heparin 5.000 UI/0.25 mL (Blausiegel) Compared With Heparin Sodium 5.000 USP (APP Pharmaceuticals)for Venous Thromboembolism Prophylaxis In Surgical Patients With Medium Risk For The Thromboembolism Development [NCT00912483] | Phase 3 | 0 participants (Actual) | Interventional | 2010-05-31 | Withdrawn |
| Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL) [NCT00800137] | Phase 4 | 984 participants (Actual) | Interventional | 2008-12-31 | Terminated(stopped due to At time of pre-specified 2nd interim analysis) |
| CoV-Hep Study: Randomized and Paired Clinical Trial Comparing Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19 [NCT04487990] | | 118 participants (Actual) | Interventional | 2020-06-29 | Completed |
| An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Tran [NCT00911300] | Phase 2 | 349 participants (Actual) | Interventional | 2009-08-31 | Completed |
| Prospective Cohort Study of Bone Mineral Density and Calcium-phosphorus Metabolism in RSA Patients: Low Molecular Weight Heparin Use Versus Control [NCT05878574] | | 344 participants (Anticipated) | Observational | 2022-11-01 | Recruiting |
| A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of VNX001 Compared to Placebo, the Individual Components of Lidocaine, and Heparin in Subjects With Interstitial Cystitis/Bladd [NCT05737121] | Phase 2 | 120 participants (Anticipated) | Interventional | 2023-05-22 | Recruiting |
| Metaxa's Thromboprophylaxis Program in Oncological & Surgical Patients [NCT04248348] | | 600 participants (Anticipated) | Observational | 2018-12-01 | Recruiting |
| Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial) [NCT01930396] | Phase 4 | 191 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction [NCT05247424] | Phase 4 | 600 participants (Anticipated) | Interventional | 2022-03-10 | Recruiting |
| "A Pilot Study to Evaluate the Safety and Preliminary Evidence of an Effect of ODSH (2-O, 3-O Desulfated Heparin) in Accelerating Platelet Recovery in Pediatric Patients With a Recurrent Solid Tumor Receiving ICE Chemotherapy" [NCT02164097] | Phase 1 | 4 participants (Actual) | Interventional | 2015-01-31 | Terminated(stopped due to low accrual) |
| A Randomized, Double-blind, Triple-dummy, Dose-ranging Study, Including an Active Control of Unfractionated Heparin and Eptifibatide, to Evaluate the Clinical Efficacy and Safety of Otamixaban, in Patients With Non-ST Elevation Acute Coronary Syndrome and [NCT00317395] | Phase 2 | 3,241 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Effect of the Use of Anticoagulant Therapy During Hospitalization and Discharge in Patients With COVID-19 Infection [NCT04508439] | | 130 participants (Anticipated) | Interventional | 2020-06-20 | Recruiting |
| Multi-centre, Double-blind, Randomized, Controlled Trial Comparing Intra-operative Regional Heparinization to Placebo for the Prevention of Deep Vein Thrombosis Following Total Knee Arthroplasty [NCT00253851] | Phase 4 | 30 participants (Actual) | Interventional | 2003-07-31 | Completed |
| An Open-Label Randomized Control Trial of Pre-Operative Low Molecular Weight Heparin Versus Tapered Warfarin as Bridging Therapy for Patients With Implantation of Pacemaker or Defibrillator [NCT02094157] | Phase 3 | 173 participants (Actual) | Interventional | 2007-12-31 | Terminated(stopped due to Change of practice made further recruitment impossible) |
| Comparison of Thrombgolytic and Anticoagulation Therapy in Submassive Pulmonary Embolism in Context of Pulmonary Hypertension, Right Heart Failure and Patient Functional Ability [NCT02132689] | Phase 4 | 100 participants (Actual) | Interventional | 2011-03-31 | Completed |
| Effect of Bivalirudin on Aortic Valve Intervention Outcomes 2/3 (BRAVO 2/3) [NCT01651780] | Phase 3 | 803 participants (Actual) | Interventional | 2012-10-31 | Completed |
| Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study [NCT04485429] | Phase 3 | 0 participants (Actual) | Interventional | 2020-07-20 | Withdrawn(stopped due to It was not possible to perform the study due to the availability and logistics of porcine heparin) |
| Apixaban Versus Low-Molecular Weight Heparin For Thromboprophylaxis In Patients With Acute Spinal Cord Injury: A Pilot Study [NCT03200613] | Phase 2 | 8 participants (Actual) | Interventional | 2017-09-01 | Terminated(stopped due to study not feasible due to too slow recruitment) |
| Study of the Efficacy, Safety and Tolerability of Low Molecular Weight Heparin vs. Unfractionated Heparin as Bridging Therapy in Patients With Embolic Stroke Due to Atrial Fibrillation [NCT02159287] | Phase 2 | 80 participants (Anticipated) | Interventional | 2014-01-31 | Recruiting |
| A Prospective Randomised Controlled Trial [NCT02086019] | | 250 participants (Actual) | Interventional | 2014-05-01 | Completed |
| Citrate Versus Heparin in Continuous Renal Replacement Therapy : Effect on Cardiovascular System and Clot Circuit in Critically Ill Patients [NCT04865510] | | 41 participants (Actual) | Interventional | 2019-02-04 | Completed |
| COVID-19 Disease and Coagulopathy: Assessment of Clotting Factor Levels in Patients With SARS-CoV-2 Infection [NCT04787510] | | 50 participants (Actual) | Observational [Patient Registry] | 2020-12-23 | Completed |
| An Investigation of Clinical Outcomes and Inflammatory Response to Heparin Free Extracorporeal Membrane Oxygenation Support During Clinical Lung Transplantation - a Prospective Double-blind Randomised Feasibility Study [NCT05697692] | Phase 4 | 80 participants (Anticipated) | Interventional | 2022-12-20 | Recruiting |
| Regional Citrate Anticoagulation for Continuous Renal Replacement Therapy During Veno-venous ECMO: a Crossover Randomized Controlled Study [NCT05148026] | | 20 participants (Anticipated) | Interventional | 2021-11-14 | Recruiting |
| A Phase IIIb, Randomised, Open Label Trial With 3 Parallel Groups: Full Dose TNK-tPA Together With Heparin Sodium, Full Dose TNK-tPA Together With Enoxaparin, and Half Dose TNK-tPA Together With Abciximab and Heparin Sodium in Patients With Acute Myocardi [NCT02181985] | Phase 3 | 5,989 participants (Actual) | Interventional | 2000-05-31 | Completed |
| A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia [NCT02873338] | Phase 2 | 75 participants (Actual) | Interventional | 2016-08-31 | Completed |
| Randomized Double Blind Trial Comparing Heparin and Placebo as Additives to Continuous Infusion in Intensive Care Neonates for Prevention of Ventilation [NCT00196469] | Phase 4 | 270 participants (Anticipated) | Interventional | 2003-12-31 | Recruiting |
| A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction [NCT03537586] | | 135 participants (Anticipated) | Interventional | 2018-06-29 | Recruiting |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00894998] | Phase 3 | 104 participants (Actual) | Interventional | 2009-06-30 | Completed |
| High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion [NCT02570243] | Phase 4 | 1,800 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00905216] | Phase 3 | 104 participants (Anticipated) | Interventional | 2009-06-30 | Recruiting |
| A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer [NCT05498428] | Phase 2 | 390 participants (Anticipated) | Interventional | 2022-11-11 | Recruiting |
| The Clinical Features and Pregnancy Outcomes of Patients With Connective Tissue Disease :a Prospective Cohort Study [NCT04918524] | | 126 participants (Anticipated) | Observational | 2018-09-11 | Recruiting |
| Heparin-binding Protein and Heparins [NCT04146493] | | 60 participants (Actual) | Observational | 2019-04-01 | Completed |
| Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC [NCT02654561] | Phase 3 | 600 participants (Anticipated) | Interventional | 2018-04-12 | Recruiting |
| Dual Arm Factorial Randomized Trial in Patients w/ST Segment Elevation AMI to Compare the Results of Using Anticoagulation With Either Unfractionated Heparin + Routine GP IIb/IIIa Inhibition or Bivalirudin + Bail-out GP IIb/IIIa Inhibition; and Primary An [NCT00433966] | Phase 3 | 3,602 participants (Actual) | Interventional | 2005-03-31 | Completed |
| EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study [NCT01084993] | Phase 4 | 2,000 participants (Anticipated) | Interventional | 2010-03-31 | Recruiting |
| Randomized Trial of Prasugrel Plus Bivalirudin vs. Clopidogrel Plus Heparin in Patients With Acute STEMI [NCT00976092] | Phase 4 | 548 participants (Actual) | Interventional | 2009-09-30 | Active, not recruiting |
| Comparison of HYDROLINK™ and HeprAN™ mEmbranes in a Per Dialytic Heparin Weaning Strategy in Chronic Hemodialysis Patients [NCT05117450] | | 302 participants (Anticipated) | Interventional | 2021-11-17 | Recruiting |
| Study on Safety and Efficacy of Bivalirudin During Short-term Intervention of Non-infarction Related Artery for Acute ST-segment Elevation Myocardial Infarction After Emergency Percutaneous Coronary Intervention [NCT04475835] | | 100 participants (Anticipated) | Interventional | 2021-01-12 | Recruiting |
| ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS IN PATIENTS WITH COLORECTAL CANCER UNDERGOING LAPAROSCOPIC SURGERY: INCIDENCE OF VENOUS THROMBOEMBOLISM AND BLEEDING COMPLICATIONS. THE PRO-LAPS STUDY. [NCT01589146] | Phase 3 | 400 participants (Anticipated) | Interventional | 2010-09-30 | Recruiting |
| Open Randomized Multi-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran (LMW-SD) in Islet Transplantation After Kidney Transplantation (CIT-01B) [NCT00790439] | Phase 2 | 0 participants (Actual) | Interventional | 2008-07-31 | Withdrawn(stopped due to Due to funding limitations) |
| Low-Molecular-Weight Heparin for DVT Prophylaxis After Open Reduction and Internal Fixation of Ankle Fractures: A Randomized, Prospective Trial [NCT01029821] | | 100 participants (Anticipated) | Interventional | 2010-02-28 | Recruiting |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00894673] | Phase 3 | 104 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00894829] | Phase 3 | 104 participants (Actual) | Interventional | 2009-06-30 | Completed |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00894985] | Phase 3 | 104 participants (Actual) | Interventional | 2009-06-30 | Completed |
| Combined Sonographic Examination and Placenta Protein 13 (PP13) to Compare the Risk for Development of Preeclampsia Among Among Pregnant Women With and Without a History of Preterm Delivery and Those Treated by Progesterone or Clexane [NCT00928213] | Phase 2/Phase 3 | 1,000 participants (Anticipated) | Interventional | 2009-08-31 | Not yet recruiting |
| The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial. [NCT04256525] | Phase 4 | 1,640 participants (Anticipated) | Interventional | 2020-05-01 | Recruiting |
| Acute Effect of Intensive Insulin Infusion on Intestinal Triglyceride-rich-lipoprotein-apoB48 Metabolism in Type 2 Diabetic Patients [NCT00950209] | | 20 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Comparison of the Efficacy and Safety for Different Regimen of Venous Thromboembolism Pharmacoprophylaxis Among Severely Burn Patients [NCT05237726] | | 20 participants (Actual) | Interventional | 2020-04-05 | Completed |
| The Efficacy of Prophylactic Use of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development After Excision of Previous Scar [NCT02708628] | | 120 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Regional Citrate Versus Systemic Heparin Anticoagulation for Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury [NCT02669589] | Phase 4 | 638 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Efficacy and Safety of Short-term Postoperative Anticoagulant Therapy to Prevente Thrombosis in Arterovenous Fistula [NCT04164693] | | 110 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting |
| Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set [NCT02687256] | Phase 1 | 24 participants (Actual) | Interventional | 2016-03-31 | Completed |
| Randomized Controlled Trial Investigating the Efficacy and Safety of Nebulized Heparin Versus Placebo in Burn Patients With Inhalation Trauma (Hepburn) [NCT01773083] | Phase 3 | 13 participants (Actual) | Interventional | 2013-10-31 | Terminated(stopped due to insufficient recruitment of patients and high costs associated with the purchase and blinding of study medication) |
| A Multicenter, Randomized-Controlled Trial to Evaluate the Efficacy and Safety of Antithrombotic Therapy for Prevention of Arterial and Venous Thrombotic Complications in Critically-Ill COVID-19 Patients [NCT04409834] | Phase 4 | 390 participants (Actual) | Interventional | 2020-08-05 | Completed |
| High Dose Versus Low Dose Heparinization in Patients Undergoing Offpump Coronary Artery Bypass [NCT02812355] | Phase 4 | 900 participants (Anticipated) | Interventional | 2017-01-31 | Recruiting |
| Bivalirudin in Stable Ischemic Heart Disease Patients Undergoing PCI [NCT02787317] | Phase 4 | 1,770 participants (Anticipated) | Interventional | 2016-05-31 | Not yet recruiting |
| Open Study to Evaluate Safety and Efficacy of Allogenic Islet Transplantation Using Islets Coated With Immobilised Heparin [NCT00678990] | | 10 participants (Anticipated) | Interventional | 2019-01-31 | Not yet recruiting |
| The STrategic Reperfusion Early After Myocardial Infarction (STREAM) Anticoagulation With Enoxaparin vs. Unfractionated Heparin in Primary PCI Sub-study. [NCT00882635] | Phase 3 | 44 participants (Actual) | Interventional | 2008-10-31 | Completed |
| The Effect of Exercise on Pharmacodynamics and Pharmacokinetics of a Single Dose of Unfractionated Heparin: A Randomized, Controlled, Cross-over Study [NCT06174961] | Phase 4 | 15 participants (Anticipated) | Interventional | 2023-09-22 | Recruiting |
| Effect of Heparinization on Intracranial Aneurysm [NCT05749393] | | 90 participants (Anticipated) | Interventional | 2023-04-30 | Recruiting |
| The Female Microbiome in Patients Undergoing Bladder Instillation Therapy [NCT05414305] | Phase 2 | 29 participants (Actual) | Interventional | 2020-10-01 | Active, not recruiting |
| Randomized Clinical Trial of Sodium Heparin Effectiveness and Security in Patients Submitted to Heart Surgery Using Bypass [NCT00894959] | Phase 3 | 104 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Efficacy and Safety Study to Evaluate the Use of Nebulized Heparin in Patients With Severe Acute Respiratory Syndrome Covid-19 (SARS-CoV-2) [NCT04530578] | Phase 4 | 200 participants (Anticipated) | Interventional | 2020-06-01 | Recruiting |
| Post Marketing Study of the GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease (VIPER) [NCT00541307] | | 119 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Heparin Binding Protein (HBP) in Sepsis for the Prediction of Disease Progression [NCT02533011] | | 1,055 participants (Actual) | Observational | 2015-07-31 | Completed |
| A Phase I/II Study of the Tolerability of Lenalidomide and Low Dose Dexamethasone in Previously Treated Multiple Myeloma Patients With Impaired Renal Function [NCT00790842] | Phase 1/Phase 2 | 63 participants (Actual) | Interventional | 2009-01-21 | Terminated(stopped due to Slow enrollment) |
| Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma [NCT00577096] | | 120 participants (Actual) | Interventional | 2001-10-31 | Completed |
| The Efficiency and Safety of Bivalirudin in latE percuTaneous Coronary inTervention for Patients With ST-Elevation Myocardial InfaRction (BETTER Trial) [NCT04185077] | Phase 4 | 1,200 participants (Anticipated) | Interventional | 2019-11-30 | Not yet recruiting |
| The Safety and Pharmacodynamics of Two Doses of Dabigatran Etexilate in Patients Undergoing Cardiac Catheterization [NCT00818753] | Phase 2 | 53 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Evaluation of Anti-Xa Levels in Surgery Patients Receiving Weight-based Heparin [NCT03516656] | Early Phase 1 | 20 participants (Actual) | Interventional | 2018-03-23 | Completed |
| Anticoagulant Treatments Evaluation During Percutaneous Coronary Angioplasty in Stable Patients [NCT00669149] | Phase 4 | 99 participants (Actual) | Interventional | 2008-06-30 | Terminated(stopped due to recruitment difficulties) |
| A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure. [NCT00914472] | Phase 3 | 120 participants (Anticipated) | Interventional | 2010-04-30 | Active, not recruiting |
| Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin In High Risk Patients Of Non-ST Elevation Acute Coronary Syndromes Intended For Early Invasive Strategy [NCT00435487] | Phase 4 | 173 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to See termination reason in detailed description.) |
| Phase 2a, Multi-Center, Open Label, Randomized, Feasibility/Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Subjects Undergoing Elective PCI After Pretreatment With Clopidogrel and Aspirin [NCT00715455] | Phase 2 | 26 participants (Actual) | Interventional | 2007-10-31 | Completed |
| A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis. [NCT00712257] | | 27 participants (Actual) | Interventional | 2007-11-30 | Terminated(stopped due to Due to safety concerns) |
| FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstabl [NCT00790907] | Phase 4 | 3,235 participants (Actual) | Interventional | 2009-02-28 | Completed |
| A Randomised Study of Taurolock for the Locking of Tunneled Central Venous Catheters in Children With Malignant Diseases. [NCT00735813] | Phase 3 | 129 participants (Actual) | Interventional | 2008-04-30 | Completed |
| Comparative Effectiveness of 30% Trisodium Citrate and Heparin Lock Solutions in Preventing Infection and Dysfunction of Hemodialysis Catheters: a Randomized Controlled Trial (CITRIM Trial) [NCT02563041] | Phase 4 | 179 participants (Actual) | Interventional | 2012-07-31 | Completed |
| [NCT00749619] | Phase 3 | 0 participants | Interventional | 2007-05-31 | Completed |
| Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women [NCT00473603] | | 13 participants (Actual) | Interventional | 2006-12-31 | Completed |
| Heparin Management for Cardiopulmonary Bypass in Cardiac Surgery: A Prospective, Comparative and Randomized Study Evaluating a Dosage Based on the Ideal Body Weight in Obese Patients [NCT02675647] | Phase 4 | 60 participants (Anticipated) | Interventional | 2015-12-31 | Recruiting |
| Safety and Effectiveness of 4% Tetrasodium Ethylenediaminetetraacetic Acid Catheter Lock Solution in Preventing Central Venous Catheter Occlusions in Children With Intestinal Failure: A Randomized Controlled Trial [NCT05879835] | | 124 participants (Anticipated) | Interventional | 2023-09-30 | Not yet recruiting |
| Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial [NCT02860299] | Phase 4 | 76 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Ethanol Lock Therapy for the Prevention of Catheter Related Blood Stream Infections [NCT00948441] | | 16 participants (Actual) | Interventional | 2008-08-31 | Completed |
| A Randomized, Partial-Blind, Placebo and Positive-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of HSK36273 in Healthy Subjects. [NCT05742126] | Phase 1 | 54 participants (Actual) | Interventional | 2022-04-11 | Completed |
| Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study [NCT04241380] | | 150 participants (Anticipated) | Interventional | 2020-02-20 | Recruiting |
| ACTION-1: ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair, a Randomised Trial. [NCT04061798] | Phase 4 | 750 participants (Anticipated) | Interventional | 2020-03-02 | Recruiting |
| Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis [NCT02618317] | Phase 4 | 75 participants (Actual) | Interventional | 2013-07-31 | Completed |
| Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation [NCT04121611] | | 25 participants (Anticipated) | Interventional | 2019-10-14 | Recruiting |
| Comparison of Topical Tranexamic Acid and Floseal® on Blood Loss After Total Knee Arthroplasty in Patients With a Thromboembolic Risk [NCT02865174] | Phase 4 | 90 participants (Anticipated) | Interventional | 2016-09-30 | Not yet recruiting |
| Bicarbonate vs Heparin Catheter Lock in Chronic Hemodialysis Patients [NCT04054128] | Phase 4 | 60 participants (Actual) | Interventional | 2019-09-11 | Active, not recruiting |
| A Feasibility Study to Inform the Design of a Randomised Controlled Trial to Identify the Most Clinically and Cost Effective Length of Anticoagulation With Low Molecular Weight Heparin In the Treatment of Cancer Associated Thrombosis [NCT01817257] | Phase 2 | 2 participants (Actual) | Interventional | 2013-12-31 | Terminated(stopped due to Early findings showed trial was not feasible) |
| A Randomized Controlled Trial Comparing Low Molecular Weight Heparin and Aspirin to Aspirin Alone in Women With Unexplained Recurrent Pregnancy Loss [NCT00564174] | | 88 participants (Actual) | Interventional | 2000-03-31 | Terminated(stopped due to interim analysis found no difference in LB rate and lower than expected event rate) |
| Efficacy and Safety of an Ethanol/Sodium Citrate Locking Solution to Prevent Hemodialysis Catheter-Related Infections: A Pilot Study [NCT01394458] | | 40 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Ethanol Lock and Risk of Catheter Related Blood Stream Infection in Patients With Haemodialysis Catheter [NCT05953675] | | 280 participants (Anticipated) | Interventional | 2018-08-01 | Active, not recruiting |
| Heparinization vs Salinization of the Peripheral Venous Catheter: a Randomized Clinical Trial [NCT05209841] | | 3,450 participants (Anticipated) | Interventional | 2022-03-16 | Not yet recruiting |
| Safety and Efficacy of Preoperative Administration of Heparin as Thromboprophylaxis in Major Thoracic Surgery [NCT02940444] | Phase 1/Phase 2 | 2,000 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
| Fixed Low-dose Heparin Versus Standard Adjusted-dose Heparin Infusion in Adults Receiving Venovenous Extracorporeal Membrane Oxygenation (ECMO) With a Heparin Bonded Circuit. [NCT02966080] | | 0 participants (Actual) | Interventional | 2016-12-31 | Withdrawn(stopped due to No participants enrolled, study will not be conducted.) |
| Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers [NCT04394182] | | 15 participants (Anticipated) | Interventional | 2020-04-21 | Suspended(stopped due to lack of recruitment) |
| Efficacy and Safety of Body Weight Adjusted Nadroparin vs Standard Unfractionated Heparin for the Initial Treatment of Pulmonary Thromboembolism：a Multi-Centre, Randomised Controlled Trial in China [NCT00796692] | Phase 4 | 274 participants (Actual) | Interventional | 2002-06-30 | Completed |
| Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies [NCT04764396] | | 100 participants (Anticipated) | Interventional | 2021-03-12 | Recruiting |
| NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLI [NCT00934167] | Phase 2/Phase 3 | 140 participants (Anticipated) | Interventional | 2010-05-31 | Active, not recruiting |
| Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study. [NCT02746185] | Phase 3 | 159 participants (Actual) | Interventional | 2016-09-30 | Completed |
| Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy [NCT04645550] | Phase 4 | 120 participants (Actual) | Interventional | 2020-11-22 | Completed |
| Addition of Prednisolone and Heparin in Patients With Repeated Implantation Failures: a Prospective Clinical Study [NCT01590173] | Phase 2/Phase 3 | 86 participants (Actual) | Interventional | 2012-01-31 | Completed |
| A Novel Catheter Lock Solution for Treatment of Tunneled Hemodialysis Catheter-Associated Bacteremia [NCT00614679] | Phase 1 | 18 participants (Actual) | Interventional | 2006-10-31 | Completed |
| Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy [NCT05257213] | | 100 participants (Anticipated) | Interventional | 2022-02-14 | Recruiting |
| A Randomised Controlled Trial Comparing the Effectiveness of Heparin Bonded or Antibiotic Impregnated Central Venous Catheters (CVCs) With Standard CVCs for the Prevention of Hospital Acquired Blood Stream Infection in Children [NCT01029717] | Phase 3 | 1,859 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Effect of Intravenous Continuous Infusion Heparin on Rates of Venous Thromboembolism in High-Risk, Critically Ill Patients [NCT02707263] | | 0 participants (Actual) | Interventional | 2016-03-31 | Withdrawn |
| A Multinational, Randomized, Double-Blind, Double-Dummy, Exploratory, Parallel Group, Dose-Ranging Phase II Study to Evaluate Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Several Intravenous Regimens of Factor Xa Inhibitor Otamixaban [NCT00133731] | Phase 2 | 947 participants (Actual) | Interventional | 2004-09-30 | Completed |
| Prognosis Related to Induced Thrombopenia With Heparin Under Venoarterial ECMO in Reanimation [NCT03979625] | | 39 participants (Actual) | Observational | 2016-01-01 | Completed |
| Partial Thromboplastin Time During the First 24 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin: Comparison of a 2 Times Per Day Versus Per 3 Times a Day Dosage [NCT01070875] | | 53 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage [NCT01917799] | Phase 4 | 150 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting |
| INHALEd Nebulised Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 (INHALE-HEP) Australia [NCT05184101] | Phase 2/Phase 3 | 100 participants (Anticipated) | Interventional | 2023-08-31 | Recruiting |
| Low Dose Unfractioned Heparin for Treatment of Sepsis Caused by Abdominal Infection：a Pilot Study [NCT04861922] | Phase 3 | 100 participants (Anticipated) | Interventional | 2021-05-11 | Recruiting |
| RCT for the Treatment of Hemodialysis Catheter-Related Bacteremia [NCT02040818] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2013-11-30 | Withdrawn(stopped due to no enrollment) |
| Do Different Heparin Brands Influence Bleeding in Coronary Surgery [NCT00848796] | | 100 participants (Actual) | Interventional | 2006-09-30 | Completed |
| [NCT00000472] | Phase 3 | 0 participants | Interventional | 1989-04-30 | Completed |
| Combined Administration of Inhaled DNase, Baricitinib and Tocilizumab as Rescue Treatment in Severe COVID-19 Patients [NCT05279391] | | 150 participants (Anticipated) | Interventional | 2020-10-25 | Recruiting |
| INHALEd Unfractionated HEParin for the Treatment of Hospitalized Patients With COVID-19 Pneumonia [NCT04723563] | Phase 4 | 50 participants (Actual) | Interventional | 2021-02-22 | Completed |
| Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter. [NCT00890214] | Phase 4 | 23 participants (Actual) | Interventional | 2007-09-30 | Completed |
| PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot) [NCT00182364] | Phase 3 | 120 participants | Interventional | 2003-02-28 | Completed |
| The Potential Role for Adenosine in the Haemodynamic Effects of Free Fatty Acids [NCT00184899] | | 20 participants | Interventional | 2005-08-31 | Completed |
| A Randomized Controlled Pilot Trial of When Heparin Stopped for Anticoagulation During Extracorporeal Membrane Oxygenation Decannulation [NCT05239637] | | 40 participants (Anticipated) | Interventional | 2022-02-15 | Recruiting |
| Prospective Randomized Phase IV Open Label Comparative Study Of Dalteparin vs Unfractionated Heparin For The Prevention Of Venous Thromboembolism (VTE) In Hospitalized Acutely Ill Medical Patients. [NCT00445328] | Phase 4 | 84 participants (Actual) | Interventional | 2007-06-30 | Terminated(stopped due to See Detailed Description) |
| Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication [NCT01044888] | | 199 participants (Actual) | Interventional | 2007-04-30 | Completed |
| Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia [NCT02645240] | Phase 4 | 97 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Recurrent Urinary Tract Infections and Heparin: a Double-blind Randomized Trial (RUTIH Trial) [NCT02246270] | Phase 1/Phase 2 | 30 participants (Anticipated) | Interventional | 2017-11-28 | Recruiting |
| Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III [NCT00464087] | Phase 3 | 100 participants (Actual) | Interventional | 2007-06-30 | Completed |
| A Multicentre, Randomized Controlled Study of Blood Clotting After Transcatheter Atrial Septal Defect Closure [NCT01086046] | | 450 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting |
| Multi-centre, Multi-national, Prospective, Randomised, Open-label, Comparison of Bivalirudin to Other Guideline Based Current Therapies (Excluding Bivalirudin) [NCT01087723] | Phase 3 | 2,198 participants (Actual) | Interventional | 2010-03-31 | Completed |
| Unfractioned Heparin for Treatment of Sepsis: A Randomized Clinical Trial (The HETRASE Study) [NCT00100308] | Phase 3 | 319 participants (Actual) | Interventional | 2005-07-31 | Completed |
| [NCT00207779] | Phase 3 | 0 participants | Interventional | 2005-05-31 | Completed |
| Pilot Study of Intensified Chemotherapy and Simultaneous Treatment With Heparin in Out-patients With Pancreatic Cancer. [NCT01945879] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2003-01-31 | Completed |
| A Double Blinded, Randomized, Controlled Investigation of Taurolidine-citrate/Heparin Catheter Lock Solution Versus Heparin in Patients on Home Parenteral Nutrition With Previously Proven High Risk of Catheter Related Blood Stream Infections. [NCT01948245] | Phase 4 | 42 participants (Anticipated) | Interventional | 2013-10-31 | Active, not recruiting |
| Comparison of Two Strategies for Protamine Dosing After Anticoagulation in Cardiovascular Surgery Regarding Postoperative Bleeding: Total Heparin Administered Versus Residual Heparin Determined by a Pharmacokinetic Model [NCT04628884] | Phase 4 | 136 participants (Anticipated) | Interventional | 2020-11-15 | Recruiting |
| [NCT01956955] | Phase 4 | 150 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
| Citrate Versus Heparin for the Lock of Non-tunneled Hemodialysis Catheters in Patients Hospitalised in ICU = Multicentre, Controlled, Randomised Superiority Trial [NCT01962116] | Phase 3 | 405 participants (Actual) | Interventional | 2013-06-14 | Completed |
| Phase 4 Study of Argatroban for Preventing Restenosis After Extracranial Vertebral Artery Stenting [NCT01980316] | Phase 4 | 114 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Multi-Center, Prospective, Randomized, Open-Label, Sponsor-Blinded, Active-Control (Heparin) Clinical Investigation to Evaluate the Safety and Effectiveness of B-Lock™ as an Antimicrobial Catheter Lock Solution in Dialysis Patients With a Central Venous C [NCT01989091] | Phase 3 | 270 participants (Actual) | Interventional | 2012-07-31 | Terminated(stopped due to Did not meet predetermined primary endpoint) |
| D-dimer Adjusted Versus Therapeutic Dose Low-molecular-weight Heparin in Patients With COVID-19 Pneumonia [NCT04584580] | Phase 4 | 50 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| Clinical Outcomes About Heparin Surface Modified Aspheric Lens [NCT02026765] | | 20 participants (Actual) | Interventional | 2013-11-30 | Completed |
| Prevention of Tunneled Cuffed Catheter Malfunction With Prophylactic Use of a Taurolidine Locking Solution Containing Urokinase : a Multicentric Randomized Controlled Trial [NCT02036255] | Phase 3 | 68 participants (Actual) | Interventional | 2015-05-31 | Completed |
| A Phase 3, Randomized, Parallel-Group, Multi-Center, Multi-National Study for the Evaluation of Efficacy and Safety of (LMW) Heparin/Edoxaban Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis (DVT) and or Pulmonary Embolism ( [NCT00986154] | Phase 3 | 8,292 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Optimal Heparin Dosing Regimens for Cardiopulmonary Bypass [NCT00587444] | Phase 3 | 270 participants (Actual) | Interventional | 2001-06-30 | Completed |
| Multizenterstudie Der European Assessment Group for Lysis in the Eye (EAGLE) Zur Behandlung Des Zentralarterienverschlusses (ZAV): Lysetherapie Versus Konservative Therapie [NCT00637468] | Phase 3 | 84 participants (Actual) | Interventional | 2002-09-30 | Terminated(stopped due to Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.) |
| Effects of UFH and LMWH on Osteoprotegerin and RANKL Plasma Levels in Hemodialysis Patients [NCT00669721] | | 40 participants (Anticipated) | Interventional | 2008-03-31 | Recruiting |
| Anticoagulant Efficacy and Safety of BivalirUdin Versus heparIn During coiL Embolization in Patients With ruptureD Intracranial Aneurysms: an Open-label, Multicenter, Randomized Pilot Study（BUILD） [NCT04532333] | Phase 3 | 236 participants (Anticipated) | Interventional | 2020-08-31 | Not yet recruiting |
| Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS). [NCT02674906] | | 75 participants (Actual) | Interventional | 2016-02-29 | Completed |
| Monitoring Anticoagulation With Argatroban in Patients on Extracorporeal Membrane Oxygenation for Severe Lung Failure Using Anti-FIIa. Monitoring Anticoagulation With Unfractionated Heparin in Patients on Extracorporeal Membrane Oxygenation for Severe Lun [NCT06038682] | | 100 participants (Actual) | Observational | 2020-04-01 | Completed |
| InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial) [NCT04406389] | Phase 4 | 14 participants (Actual) | Interventional | 2020-10-13 | Terminated(stopped due to Low accrual) |
| MANCO: Measuring the ACT During Non-cardiac Arterial Procedures. [NCT03426293] | | 500 participants (Anticipated) | Observational [Patient Registry] | 2016-12-21 | Recruiting |
| Platelet Function With New Pediatric Oxygenator and Heparin and Non Heparin Coating in Pediatric Cardiac Surgery [NCT01648712] | | 48 participants (Actual) | Interventional | 2013-03-31 | Terminated(stopped due to for difficulty to enroll patients in the study) |
| Prospective Randomized Study Of Anticoagulation Monitoring With Thromboelastography Versus aPTT During Extracorporeal Membrane Oxygenation In Adults [NCT02271126] | Phase 1 | 42 participants (Actual) | Interventional | 2014-09-02 | Completed |
| Efficacy and Safety of Ethanol Lock Therapy for the Prevention of Central Line-associated Bloodstream Infections [NCT02890875] | | 3 participants (Actual) | Interventional | 2016-08-31 | Terminated(stopped due to Low recruitment) |
| Effects of Sequential Compression Devices on Coagulation Parameters Assessed by TEG® in Patients Undergoing Major Abdominal Surgery [NCT00726570] | | 40 participants (Actual) | Interventional | 2008-08-31 | Terminated(stopped due to Failed to reach the expected enrollment rates by the end of 2010) |
| Randomized Control Trial on Citrate as the Central Venous Catheter Lock Solution [NCT00862966] | | 40 participants (Anticipated) | Interventional | 2009-04-30 | Not yet recruiting |
| Comparison of Heparin vs. no Heparin on Duration of Peripherally Inserted Central Catheter Patency in Neonates [NCT00879957] | | 0 participants (Actual) | Interventional | 2010-01-31 | Withdrawn(stopped due to A study was published regarding the same question this study had.) |
| A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach [NCT04374799] | Phase 3 | 3,600 participants (Anticipated) | Interventional | 2020-10-05 | Recruiting |
| Open Randomized Mult-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation (CIT-01) [NCT00789308] | Phase 2 | 24 participants (Actual) | Interventional | 2008-07-11 | Completed |
| Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass [NCT01072747] | Phase 3 | 104 participants (Anticipated) | Interventional | 2010-04-30 | Recruiting |
| Cloxacillin as Prevention of Double Lumen Infection in Hemodialysis Patients [NCT00885300] | | 100 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure [NCT00828776] | Phase 2/Phase 3 | 62 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Non-randomized, Open-label, Historical Control, Single Group Assignment Trial of a Reduced Dose of Unfractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions [NCT00735280] | Phase 4 | 2,505 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Evaluation of the Efficacy and Safety of Regional Anticoagulation With Citrate in Extended Hemodialysis in Patients With Acute Renal Injury Admitted to an Intensive Care Unit [NCT04297839] | Phase 3 | 200 participants (Anticipated) | Interventional | 2019-02-12 | Suspended(stopped due to DUE TO CORONAVIRUS DISEASE, ACTIVITIES INTHE HOSPITAL ARE SUPRESSED) |
| Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol [NCT02848612] | | 459 participants (Actual) | Observational | 2015-11-20 | Completed |
| A Prospective Study of Coronary Artery Bypass Graft and/or Aortic Valve Replacement With Conventional Versus Half Heparin Dose Under Closed and Coated Extra Corporeal Circulation System (MECC) - APPACHES Study. [NCT00657475] | Phase 4 | 238 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Relationship Between Activated Clotting Time and Occlusion of Radial Artery When Used as Vascular Access for Percutaneous Endovascular Procedures. [NCT02762344] | | 2,168 participants (Anticipated) | Observational [Patient Registry] | 2016-05-31 | Recruiting |
| Pivotal/Phase III Multicentered, Two-Arm, Randomized Study Comparing the Effects of AAT-023 Solution (Zuragen), and Heparin on the Incidence of Catheter Related Blood Stream Infections in Tunneled Chronic Central Venous Catheters for Dialysis [NCT00628680] | Phase 3 | 415 participants (Actual) | Interventional | 2006-07-31 | Active, not recruiting |
| The Application of Ticagrelor Combined With Low Molecular Weight Heparin During PCI [NCT02658838] | Phase 4 | 300 participants (Anticipated) | Interventional | 2015-04-30 | Active, not recruiting |
| Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT) [NCT00911157] | Phase 3 | 39 participants (Actual) | Interventional | 2008-06-30 | Completed |
| The Efficacy and Safety of Batroxobin Combined With Anticoagulation in Cerebral Venous Sinus Thrombosis [NCT04269954] | Phase 4 | 60 participants (Anticipated) | Interventional | 2020-03-01 | Not yet recruiting |
| STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism [NCT04727437] | Phase 3 | 1,466 participants (Anticipated) | Interventional | 2021-04-08 | Recruiting |
| The Effect of a Heparin-coated Dialysis Filter (Evodial) on Clotting and Intravascular Coagulation During Hemodialysis (HD) When Compared to a Conventional Polyflux Filter (170H) [NCT01388270] | Phase 4 | 12 participants (Actual) | Interventional | 2011-09-30 | Completed |
| Treatment of Intrauterine Growth Restriction With Low Molecular Heparin: Randomized Clinical Trial. Tratamiento Del Crecimiento Intrauterino Restringido Precoz Con Heparina de Bajo Peso Molecular: Ensayo clínico Aleatorizado. [NCT03324139] | Phase 3 | 50 participants (Anticipated) | Interventional | 2017-10-31 | Not yet recruiting |
| Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of a Single Escalating Dose of PER977 Following Administration of Unfractionated Heparin [NCT02206087] | Phase 1/Phase 2 | 60 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss [NCT00400387] | Phase 3 | 449 participants (Actual) | Interventional | 2006-11-30 | Completed |
| A Randomised, Open, Parallel-group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Undergoing Elective Percutaneous Coronary Intervention in C [NCT00508924] | Phase 2 | 140 participants (Actual) | Interventional | 2005-08-31 | Completed |
| A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From B [NCT02798471] | Phase 3 | 290 participants (Actual) | Interventional | 2017-03-27 | Completed |
| Apixaban for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT05304455] | | 40 participants (Actual) | Interventional | 2022-04-01 | Completed |
| Prophylaxis of Thrombosis With Implantable Devices for Central Venous Access in Cancer Patients : Phase III Randomised Study [NCT00199602] | Phase 3 | 420 participants (Actual) | Interventional | 1999-08-31 | Completed |
| Value of Abciximab in Patients With AMI Undergoing PCI After High Dose Clopidogrel Pretreatment (BRAVE 3) [NCT00133250] | Phase 4 | 800 participants (Actual) | Interventional | 2003-06-30 | Completed |
| Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin: Comparison of a 2 Times Per Day Versus a 3 Times Per Day Dosage. [NCT01855516] | | 83 participants (Actual) | Interventional | 2013-09-30 | Completed |
| Monitoring the Efficacy and Safety of Heparin and Nadroparin in the Acute Phase of Ischemic Stroke [NCT01862978] | Phase 4 | 150 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| The Use of Intravascular Paclitaxel for the Treatment of Upper-Extremity Arteriovenous Access Fistula Stenosis: A Randomized Study [NCT01868984] | Phase 2 | 10 participants (Actual) | Interventional | 2013-05-31 | Terminated(stopped due to catheters no longer available - difficult to recruit subjects) |
| Hamidiye Faculty of Nursing, University of Health Sciences [NCT05469035] | | 80 participants (Anticipated) | Interventional | 2022-07-15 | Not yet recruiting |
| Intranasal Heparin Tolerability Study [NCT04490239] | Early Phase 1 | 6 participants (Actual) | Interventional | 2020-10-09 | Completed |
| Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury [NCT03081169] | Phase 4 | 0 participants (Actual) | Interventional | 2017-04-03 | Withdrawn(stopped due to Recruitment not started due to potential conflicting study at same institution. May renew study in the future.) |
| Efficacy of Low Dose Intravenous Heparin in Preventing Thromboembolism in the SICU. [NCT01608906] | | 152 participants (Actual) | Interventional | 2007-05-31 | Completed |
| Phase II Trial of a Novel Catheter Lock Solution For Adjunctive Treatment of Hemodialysis Catheter-Associated Bacteremia. [NCT01483872] | Phase 3 | 9 participants (Actual) | Interventional | 2012-03-31 | Terminated(stopped due to The study was stopped due to poor enrollment.) |
| Comparison of A-priori Versus Provisional Heparin Therapy on Radial Artery Occlusion After Transradial Coronary Angiography and Patent Hemostasis [NCT01489917] | | 428 participants (Actual) | Interventional | 2009-05-31 | Completed |
| Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism [NCT01516840] | Phase 3 | 60 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Comparison of Bivalirudin and Unfractioned Heparin in Elective Percutaneous Coronary Interventions [NCT00448461] | Phase 4 | 850 participants (Actual) | Interventional | 2007-03-31 | Completed |
| Residual Vein Thrombosis Establishes the Optimal Duration of Low Molecular Weight Heparins in Cancer Patients With Deep Vein Thrombosis of the Lower Limbs [NCT00450645] | Phase 4 | 300 participants (Anticipated) | Interventional | 2005-03-31 | Recruiting |
| A Clinical Trial to Evaluate the Postoperative Portal Vein Infusion of 5-Fluorouracil and Heparin in Patients With Resectable Adenocarcinoma of the Colon [NCT00427310] | Phase 3 | 1,158 participants (Actual) | Interventional | 1984-03-31 | Completed |
| A Randomised Controlled Trial of Taurolidine With Heparin for Prevention of Recurrence of Catheter Related Bacteraemia in Haemodialysis Patients. [NCT01243710] | Phase 4 | 27 participants (Actual) | Interventional | 2010-08-31 | Completed |
| Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays [NCT00489437] | Phase 1 | 536 participants (Actual) | Interventional | 2007-12-31 | Completed |
| A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Multi-Center Single Dose Study to Evaluate the Safety and Effectiveness of URG101 Compared With the Individual Components Lidocaine and Heparin in Subjects With Interstitial Cystitis/Bladder Pain Sy [NCT02591199] | Phase 2 | 92 participants (Actual) | Interventional | 2015-09-30 | Terminated(stopped due to Prematurely terminated based on interim study analysis) |
| Anticoagulation in the Management of Grade I-III Blunt Cerebrovascular Injuries [NCT00494156] | | 0 participants (Actual) | Interventional | 2003-07-31 | Withdrawn(stopped due to Study halted prematurely prior to enrollment of first participant.) |
| A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Coronary Artery Bypass (OPCAB) Surgery [NCT00073593] | Phase 3 | 150 participants (Actual) | Interventional | 2003-08-31 | Completed |
| UFH is the Most Used Anticoagulant in Hemodialysis, Decreasing the Risk of Clot Formation in the Circuit. [NCT05148377] | Phase 3 | 128 participants (Actual) | Interventional | 2007-08-01 | Completed |
| Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment. [NCT02834559] | Phase 3 | 326 participants (Actual) | Interventional | 2016-10-27 | Completed |
| A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients [NCT04042324] | Phase 1/Phase 2 | 12 participants (Actual) | Interventional | 2019-09-30 | Completed |
| Clinical Study to Assess the Safety of the Use of the Drug Heparin Sodium Produced by the Laboratory Blausiegel Compared in Parallel to the Product Liquemine ® Laboratory Roche in Patients With Chronic Renal Failure. [NCT01229072] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2008-07-31 | Suspended |
| A Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome [NCT04401176] | Phase 2 | 58 participants (Actual) | Interventional | 2020-09-15 | Completed |
| Bivalirudin vs Heparin During Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Randomised Controlled Trial [NCT02897037] | Phase 3 | 380 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
| A Randomized, Double-blind, Single-dose, 2-Treatment, 2-Period, 2-Sequence Crossover Bioequivalence Study Comparing Two Formulations of Insulin Glulisine (Insulin Glulisine 300 Units/mL Versus Insulin Glulisine 100 Units/mL Marketed as Apidra® 100 Units/m [NCT02910518] | Phase 1 | 44 participants (Actual) | Interventional | 2017-02-17 | Completed |
| Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Subcutaneous Administration. [NCT01692158] | Phase 1 | 36 participants (Actual) | Interventional | 2013-03-31 | Completed |
| A Prospective, Randomized, Open-label Study to Evaluate the Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization Procedures [NCT04196309] | Phase 4 | 60 participants (Actual) | Interventional | 2017-05-25 | Completed |
| Multi-center Application of Bivalirudin in High-risk Bleeding Patients With Non-valvular Atrial Fibrillation Undergoing Percutaneous Left Atrial Appendage Occlusion [NCT04195997] | Phase 4 | 100 participants (Anticipated) | Interventional | 2020-02-01 | Not yet recruiting |
| Early Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia: A Phase IIb Trial [NCT04990830] | Phase 2/Phase 3 | 80 participants (Actual) | Interventional | 2021-02-03 | Completed |
| An Open-label Comparison of the Efficacy and Safety of the Low-molecular-weight Heparin (3000 U Anti-Xa Once Daily) With Unfractionated Heparin for the Prevention of Thromboembolic Complications in Acutely Ill Non-surgical Patients [NCT00311753] | Phase 3 | 342 participants (Actual) | Interventional | 2006-02-28 | Completed |
| Efficacy and Safety of Warfarin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy and Azygoportal Disconnection for Portal Hypertension [NCT02247414] | Phase 4 | 124 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Sirolimus-Eluting, Heparin-Coated Cobalt Chromium Balloon-Expandable Stent in the Treatment of Patients With de Novo Coronary Artery Lesions in Small Vessels (EVOLUTION) [NCT00233779] | Phase 2 | 52 participants (Actual) | Interventional | 2003-10-31 | Completed |
| The Incidence of Thromboembolic Events in Patients With Antibodies to Heparin-PF4 After Cardiac Bypass [NCT00237328] | | 1,015 participants (Actual) | Observational | 2006-06-30 | Completed |
| THE PRISM Study-Low-Molecular-Weight Heparin Versus Unfractionated Heparin for Perioperative Bridging Anticoagulation: the Patient Preference for Self-Injection Study and Related Measurements [NCT00253396] | Phase 4 | 100 participants (Anticipated) | Interventional | 2005-10-31 | Completed |
| Prospective, Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Bivalirudin and Un-fractionated Heparin in Patients Undergoing Percutaneous Coronary Interventions. ISAR-REACT-3 [NCT00262054] | Phase 4 | 4,570 participants (Actual) | Interventional | 2005-11-30 | Completed |
| [NCT01651923] | Phase 1 | 60 participants (Anticipated) | Interventional | 2013-02-28 | Not yet recruiting |
| Safety and Efficacy of the Use of Regional Anticoagulation With Citrate in Continuous Venovenous Hemofiltration, a Randomized Controlled Trial Comparing Anticoagulation With Citrate to the Low Molecular Weight Heparin Nadroparin [NCT00286273] | Phase 4 | 215 participants (Actual) | Interventional | 2003-03-31 | Completed |
| Triple-Blind Clinical Trial With Placebo Control to Evaluate the Efficacy of a Heparin of Low Molecular Weight (Bemiparin) for Treating Slow-Responding Ulcers in Diabetic Foot in Primary Care [NCT00399425] | Phase 2/Phase 3 | 84 participants | Interventional | 2001-06-30 | Terminated |
| A Study Comparing Angiomax (Bivalirudin) to Heparin With Protamine Reversal in Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass (CPB) [NCT00079586] | Phase 3 | 150 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Comparison of Low-dose Heparin Versus Standard Dose Heparin During Coronary Interventions (DEDICA Trial) [NCT01694459] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting |
| The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial [NCT05998421] | | 46 participants (Actual) | Interventional | 2022-03-01 | Completed |
| Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients [NCT01448746] | Phase 3 | 682 participants (Actual) | Interventional | 2011-10-31 | Active, not recruiting |
| Bivalirudin in Acute Myocardial Infarction vs Glycoprotein IIb/IIIa and Heparin Undergoing Angioplasty (BRIGHT):a Randomised Controlled Trial [NCT01696110] | Phase 4 | 2,194 participants (Actual) | Interventional | 2012-08-31 | Completed |
| Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers [NCT04419493] | Phase 1 | 30 participants (Actual) | Interventional | 2020-06-23 | Completed |
| Assessment of the Anti-inflammatory Effect of Unfractionated Heparin Administered Either by Intravenous Infusion Versus Subcutaneous Injection in Critically Ill Septic Patients. A Randomized Controlled Trial [NCT04313790] | Phase 2 | 40 participants (Actual) | Interventional | 2020-08-29 | Completed |
| Effect of Elevated Plasma-Free-Fatty-Acids on Renal Hemodynamic Parameters [NCT00431665] | | 9 participants | Interventional | 1999-07-31 | Completed |
| Enoxaparin Versus Unfractionated Heparin in PCI [NCT00439855] | Phase 4 | 2,100 participants | Interventional | 2003-09-30 | Completed |
| Multicentric, Randomized, Controlled, Double-blind Clinical Trial to Assess Perioperative Bridging Therapy With Sodium Bemiparin vs Calcium Unfractionated Heparin in Invasive Procedures, Outpatient Surgery and Laparoscopy Surgery in Patients Receiving Lon [NCT00484822] | Phase 3 | 206 participants (Actual) | Interventional | 2007-02-28 | Terminated(stopped due to The study has been halted prematurely due to a low recruitment.) |
| Low-molecular Heparin Infusion as Anticoagulation for Nocturnal Home Hemodialysis [NCT02957877] | Phase 4 | 12 participants (Anticipated) | Interventional | 2016-03-31 | Recruiting |
| A Randomized Trial of Ultrasound-facilitated, Catheter-directed, Thrombolysis Versus Anticoagulation for Acute Intermediate-high Risk Pulmonary Embolism: The Higher-risk Pulmonary Embolism Thrombolysis Study [NCT04790370] | Phase 4 | 544 participants (Anticipated) | Interventional | 2021-08-02 | Recruiting |
| Can Nebulised HepArin Reduce acuTE Lung Injury in Patients With SARS-CoV-2 Requiring Respiratory Support in Ireland [NCT04511923] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2020-12-23 | Recruiting |
| DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis [NCT05701917] | | 300 participants (Anticipated) | Interventional | 2023-01-06 | Recruiting |
| To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes [NCT04466618] | Phase 3 | 23 participants (Actual) | Interventional | 2021-04-15 | Completed |
| Evaluation of Anti-Xa Levels in Surgery Patients Receiving Fixed Dose Heparin [NCT02970032] | Early Phase 1 | 20 participants (Actual) | Interventional | 2016-11-10 | Completed |
| Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population [NCT01820962] | Phase 3 | 212 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to Because the inclusion rate was lower than expected.) |
| Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial [NCT04345848] | Phase 3 | 160 participants (Actual) | Interventional | 2020-04-28 | Terminated(stopped due to Low recruitement) |
| Cohort Multiple Randomized Controlled Trials Open-label of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients CORIMUNO-COAG Trial [NCT04344756] | Phase 2 | 808 participants (Anticipated) | Interventional | 2020-04-20 | Not yet recruiting |
| A Multi-center, Randomized, Open, Positive-controlled Two-stage Phase II Clinical Study to Evaluate the Efficacy, Safety and PK/PD Profiles of Anticoagulation of HSK36273 for Injection in Continuous Renal Replacement Therapy Subjects [NCT05602129] | Phase 2 | 156 participants (Anticipated) | Interventional | 2022-11-30 | Not yet recruiting |
| Differential Effects of Oral and Intravenous Lipid Administration on Leptin Signaling [NCT01520454] | | 26 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Biocompatible Cardiopulmonary Bypass and Neuropsychological Outcome After Coronary Artery Bypass Surgery [NCT00188006] | | 0 participants | Interventional | | Completed |
| Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial. [NCT00523263] | Phase 3 | 0 participants | Interventional | 1996-01-31 | Completed |
| A Two Part Study to Assess the Pharmacodynamic Effects of Unfractionated Heparin (UFH) in Healthy Volunteers and the Effects of Bendavia™ and Unfractionated Heparin When Administered Concurrently [NCT01513200] | Phase 1 | 12 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis [NCT01516814] | Phase 3 | 40 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Influence by Heparinized Flush Solution of the Radial Artery Catheter: INTEM and HEPTEM Analysis. [NCT01522846] | | 25 participants (Actual) | Observational | 2012-01-31 | Completed |
| An Open-label, Randomized, Parallel-Design Study to Characterize the Effect of Heparin on Palifermin Activity in Healthy Adult Subjects [NCT01163097] | Phase 1 | 44 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism [NCT01166997] | Phase 3 | 59 participants (Actual) | Interventional | 2010-07-31 | Completed |
| Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB) of Solid Abdominal Masses: A Randomized Prospective Trial [NCT05041335] | | 42 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
| Study of Standard Maintenance Method of Intravenous Port and Post-operation Pain Analysis [NCT03723187] | | 38 participants (Actual) | Interventional | 2016-08-01 | Completed |
| Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized，Multi-Center，Controlled Trial [NCT01531829] | Phase 4 | 460 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
| Double-blinded, Randomized Trial in Severe Pneumonia Patients With Severe Sepsis Investigating the Safety and Efficacy of Co-administration of Iloprost and Ascending Doses of Eptifibatide Compared to Low-molecular-weight Heparin [NCT01532544] | Phase 2 | 5 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to Difficulty recruiting patients, company closed down) |
| Prospective, Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention of Catheter-Related Infections and Occlusions [NCT00378781] | | 0 participants (Actual) | Interventional | | Withdrawn(stopped due to Study withdrawn.) |
| Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial [NCT04743011] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2021-06-01 | Recruiting |
| A Randomized Study to Test Peripheral Venous Catheter Lock Therapy With Either Heparin or Saline in Patients Admitted to the Internal Medicine Department [NCT02970409] | | 354 participants (Actual) | Interventional | 2015-10-17 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylactic Heparin in Patients With Severe Sepsis and Higher Disease Severity Who Are Undergoing Treatment With Drotrecogin Alfa (Activated) [NCT00049777] | Phase 4 | 2,000 participants | Interventional | 2002-12-31 | Completed |
| The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in [NCT00062803] | Phase 3 | 0 participants | Interventional | 2003-06-30 | Completed |
| [NCT00067093] | Phase 3 | 1,452 participants (Actual) | Interventional | 2003-05-31 | Completed |
| Bivalirudin Plus Stenting in Long Lesion to Avoid Periprocedural Myocardial Necrosis Trial [NCT01555658] | Phase 3 | 204 participants (Anticipated) | Interventional | 2012-04-30 | Not yet recruiting |
| Bivalirudin in Patient at High Risk of Bleeding Undergoing Percutaneous Coronary Interventions. [NCT01465503] | Phase 3 | 837 participants (Actual) | Interventional | 2008-01-31 | Completed |
| Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation. [NCT00395772] | Phase 2 | 543 participants (Actual) | Interventional | 2004-12-31 | Completed |
| PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients [NCT02984384] | Phase 3 | 12,211 participants (Actual) | Interventional | 2017-04-24 | Completed |
| STATUS-PCI: Stable Angina Therapy With Angiomax® or Unfractionated Heparin for patientS Undergoing Percutaneous Coronary Intervention [NCT01464671] | Phase 4 | 260 participants (Actual) | Interventional | 2009-07-31 | Terminated(stopped due to DSMB halted the study early due to futility. There were no safety concerns.) |
| To Study the Effect of Low Molecular Weight Heparin on the Adenomyosis Patients'Outcome of in Vitro Fertilization-embryo Transplantation [NCT04741295] | | 70 participants (Anticipated) | Interventional | 2020-02-01 | Active, not recruiting |
| Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE [NCT00147979] | | 596 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial. [NCT02227329] | Phase 1/Phase 2 | 39 participants (Actual) | Interventional | 2014-07-31 | Terminated(stopped due to Publication of guidelines advising against the use of ethanol locks.) |
| "Effects of Tinzaparin Sodium on Cardio-vascular OUtcomes and on Blood Lipids in Diabetic Patients on Chronic HEmodialysis: A Long-term, Prospective Study (The Tinzaparin COULD HELP Study)." [NCT00407641] | Phase 4 | 0 participants (Actual) | Interventional | 2009-03-31 | Withdrawn(stopped due to Financial and administrative matters did not allow collaboration among centers.) |
| PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) [NCT00182143] | Phase 3 | 3,659 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention [NCT00187408] | Phase 4 | 700 participants | Interventional | 2002-08-31 | Completed |
| [NCT00188773] | Phase 4 | 15 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
| Randomized-Double Blind Trial to Assess the Incidence and Clinical Relevance of Heparin-Induced Thrombocytopenia (HIT) Antibodies in Trauma Patients Treated With Unfractionated or Low-Molecular Weight Heparin, the HIT-TRAP Trial [NCT00196417] | Phase 4 | 600 participants | Interventional | 2003-01-31 | Active, not recruiting |
| [NCT00060554] | Phase 2 | 300 participants | Interventional | 2003-04-30 | Withdrawn(stopped due to Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.) |
| Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection: a Randomized Clinical Trial [NCT04600141] | Phase 3 | 308 participants (Actual) | Interventional | 2020-11-10 | Completed |
| Normal Saline Versus Heparinized Solution Flush for Maintaining Patency of Peripheral Venous Catheters in Children [NCT01794767] | Phase 4 | 52 participants (Anticipated) | Interventional | 2013-01-31 | Suspended(stopped due to difficult recruiting) |
| Anticoagulation-free VV ECMO for Acute Respiratory Failure: A Pilot Safety and Feasibility Randomized Clinical Trial [NCT04273607] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2022-09-01 | Recruiting |
| Heparin Requirement in Counterpulsation [NCT00445211] | Phase 2 | 46 participants (Actual) | Interventional | 2006-01-31 | Terminated(stopped due to lack of enrollment) |
| A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 [NCT04505774] | Phase 4 | 880 participants (Actual) | Interventional | 2020-09-04 | Active, not recruiting |
| Prophylactic Antimicrobial Catheter Lock in Hemodialysis Patients: A Randomized Controlled Clinical Trial [NCT00571259] | Phase 4 | 303 participants (Actual) | Interventional | 2003-09-30 | Completed |
| Ethanol Locks for the Treatment of Central Venous Line Infections [NCT00680459] | Phase 3 | 13 participants (Actual) | Interventional | 2008-05-31 | Terminated(stopped due to inability to enroll adequate number of patients) |
| Nebulized Heparin vs. Placebo for the Treatment of COVID-19 Induced Lung Injury [NCT04397510] | Phase 4 | 50 participants (Anticipated) | Interventional | 2020-06-01 | Enrolling by invitation |
| A Pilot Study of CX-01 Combined With Azacitidine in the Treatment of Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia [NCT02995655] | Phase 1 | 20 participants (Actual) | Interventional | 2017-04-07 | Completed |
| Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture [NCT03282643] | Phase 1/Phase 2 | 74 participants (Actual) | Interventional | 2016-02-16 | Completed |
| [NCT00371020] | Phase 3 | 0 participants | Interventional | 2005-02-28 | Active, not recruiting |
| A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia [NCT01048177] | Phase 2 | 0 participants (Actual) | Interventional | 2012-12-31 | Withdrawn(stopped due to This trial was never started) |
| Unfractionated Heparin in COVID-19 and Non-COVID-19 Patients - an Observational Study. [NCT05509647] | | 1,500 participants (Actual) | Observational | 2014-01-01 | Completed |
| Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19) [NCT04359212] | | 90 participants (Actual) | Observational | 2020-05-01 | Completed |
| A Randomized, Open-Label, Parallel-Group, Multi-Center Study for the Evaluation of Efficacy and Safety of Edoxaban Monotherapy Versus (LMW) Heparin/Warfarin in Subjects With Symptomatic Deep-Vein Thrombosis - Edoxaban Thrombus Reduction Imaging Study [NCT01662908] | Phase 2 | 85 participants (Actual) | Interventional | 2012-08-31 | Completed |
| PROSPECTIVE STUDY ON PREOPERATIVE VERSUS POSTOPERATIVE VENOUS THROMBOPROPHYLAXIS IN PATIENTS UNDERGOING MAJOR COLORECTAL SURGERY [NCT01976988] | Phase 3 | 410 participants (Actual) | Interventional | 2013-09-30 | Completed |
| A Phase II Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravesical Alkalinized Lidocaine-Heparin for the Symptoms of Pelvic Pain and/or Urgency of Bladder Origin [NCT00256542] | Phase 2 | 90 participants | Interventional | 2006-01-31 | Completed |
| A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Clinical Outcomes Following Percutaneous Coronary Intervention in Patients Treated With an Abciximab Bolus Plus 12-Hour Infusion Given With Either Standard-Dose Weight-Adjusted Hep [NCT00269880] | Phase 3 | 2,792 participants (Actual) | Interventional | 1995-02-28 | Completed |
| Cervical Artery Dissection in Stroke Study [NCT00238667] | Phase 3 | 250 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Steroids and Unfractionated Heparin in Critically Ill Patients With Pneumonia From COVID-19 Infection. A Multicenter, Interventional, Randomized, Three Arms Study Design [NCT04528888] | Phase 3 | 210 participants (Anticipated) | Interventional | 2020-11-25 | Recruiting |
| Heparin Anticoagulation to Improve Outcomes in Septic Shock: The HALO Pilot [NCT01648036] | Phase 2 | 76 participants (Actual) | Interventional | 2012-07-31 | Completed |
| A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG) [NCT02272582] | | 100 participants (Actual) | Interventional | 2014-09-24 | Completed |
| A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percuta [NCT00271401] | Phase 3 | 2,399 participants (Actual) | Interventional | 1996-07-31 | Completed |
| A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients [NCT00451412] | Phase 3 | 3,254 participants (Actual) | Interventional | 2007-01-31 | Completed |
| Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19: Multi-central Prospective Study [NCT04380818] | | 106 participants (Anticipated) | Interventional | 2020-06-05 | Recruiting |
| [NCT01626911] | | 60 participants (Anticipated) | Interventional | 2011-09-30 | Recruiting |
| Low Versus High Dose Unfractionated Heparin in Patients Undergoing Angiography Via the Radial Artery [NCT01634438] | Phase 4 | 49 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Comparison of Effectiveness and Complications of Heparin and Sodium Bicarbonate Catheter Lock Solutions in Non-Tunneled Hemodialysis Catheters [NCT04772209] | | 441 participants (Actual) | Interventional | 2021-02-01 | Completed |
| [NCT01652638] | Phase 1 | 44 participants (Anticipated) | Interventional | 2013-02-28 | Not yet recruiting |
| A Randomized Clinical Trial of Using Preconceptional Enoxaparin AND Low Dose Aspirin 81mg in Patient With Antiphospholipid Syndrome(APS) [NCT01661439] | | 316 participants (Anticipated) | Observational | 2012-03-31 | Recruiting |
| Double-Blind, Randomized, Controlled Trial, Small Volume Bolus of Papaverine Versus Heparin to Maintain Patency of Peripheral Arterial Catheters in Pediatric Patients Undergoing Surgical Procedures: Pilot Study [NCT03894904] | Phase 4 | 100 participants (Actual) | Interventional | 2019-04-01 | Completed |
| A Multicenter, Randomized, Controlled, Double-Blind Trial to Investigate the Clinical Efficacy and Tolerability of Early Treatment With Simvastatin 40 mg Daily for 30 Days, Followed by Simvastatin 80 mg Daily Thereafter in Tirofiban-Treated Acute Coronary [NCT00251576] | Phase 3 | 4,497 participants (Actual) | Interventional | 1999-11-01 | Completed |
| Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427] | | 695 participants (Actual) | Observational | 2012-11-30 | Completed |
| Catheter-Directed Thrombolysis Versus ANticoagulation Monotherapy in Patients With Acute Intermediate-High Risk PulmonarY Embolism: The CANARY Randomized Clinical Trial [NCT05172115] | Phase 3 | 94 participants (Actual) | Interventional | 2018-12-22 | Terminated(stopped due to Due to the COVID-19 pandemic) |
| Vascular Graft Infections - Epidemiology, Best Treatment Options, Imaging Modalities and Impact of Negative Pressure Wound Therapy [NCT01821664] | | 1,800 participants (Anticipated) | Observational [Patient Registry] | 2013-05-31 | Recruiting |
| Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure [NCT01823393] | Phase 4 | 94 participants (Actual) | Interventional | 2013-01-24 | Terminated(stopped due to Difficulty of inclusion) |
| Regional Citrate Versus Systemic Heparin Anticoagulation for Super High-flux Continuous Hemodialysis in Septic Shock: Effect on Middle Molecular Weight Molecules Clearances [NCT01839578] | | 30 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| An Open-label, Single Center Study to Evaluate the Efficacy and Safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a Treatment for Non-exudative (Dry) Age-related Macular Degeneration (AMD) [NCT01840683] | | 22 participants (Actual) | Interventional | 2013-05-31 | Completed |
| Bivalirudin Infusion for Ventricular Infarction Limitation [NCT02565147] | Phase 3 | 78 participants (Actual) | Interventional | 2014-12-19 | Terminated(stopped due to Futility at the interim analysis.) |
| Effects of Heparin on Early Patency of Arteriovenous Fistula in Angioaccess Surgery of Patients With End-Stage Renal Disease [NCT02493504] | Phase 4 | 150 participants (Actual) | Interventional | 2011-01-31 | Completed |
| INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial [NCT04635241] | Phase 2/Phase 3 | 712 participants (Anticipated) | Interventional | 2020-06-01 | Recruiting |
| A Randomized Phase II Open Label Study to Assess the Efficacy & Safety of Gemcitabine + Abraxane® With or Without ODSH (2-0, 3-0 Desulfated Heparin) as First Line Treatment of Metastatic Pancreatic Cancer [NCT01461915] | Phase 2 | 60 participants (Actual) | Interventional | 2011-11-30 | Terminated |
| Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism [NCT03862755] | Phase 4 | 581 participants (Actual) | Interventional | 2017-08-08 | Completed |
| Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration. [NCT01692171] | Phase 1 | 32 participants (Actual) | Interventional | 2013-02-28 | Completed |
| Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE) [NCT05150938] | | 5,737 participants (Actual) | Observational | 2022-03-18 | Completed |
| Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735] | | 15 participants (Actual) | Interventional | 2017-01-13 | Terminated(stopped due to Due to lack of recruitment of eligible participants) |
| Treatment of Acute Deep Vein Thrombosis of the Lower Extremity With Intraclot, Pulse-Sprayed Recombinant Tissue Plasminogen Activator, Plus Heparin and Warfarin: A Pilot Study [NCT00001713] | Phase 1 | 20 participants | Interventional | 1998-02-28 | Completed |
| Evaluation of the Efficacy of a Surface Modified Intraocular Lens in Reducing Post-Operative Inflammatory Signs Following Extracapsular Surgery in Uveitis Patients With Cataracts [NCT00001311] | Phase 2 | 80 participants | Interventional | 1992-04-30 | Completed |
| Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery [NCT01444612] | | 4,068 participants (Actual) | Observational | 2010-02-28 | Completed |
| Efficacy of Heparin Nebulization on Lung Injury Score in Inhalation Burn Injury [NCT01454869] | Phase 3 | 0 participants (Actual) | Interventional | 2012-02-29 | Withdrawn(stopped due to Due to insufficient funds) |
| Prospective Study on the Role of Intravenous Unfractionated Heparin Following Digital Replantation and Revascularization [NCT04725201] | Phase 4 | 188 participants (Anticipated) | Interventional | 2021-05-24 | Recruiting |
| Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery [NCT01462968] | | 0 participants (Actual) | Interventional | 2011-11-30 | Withdrawn(stopped due to The study never started due to problems with Laboratory facilities in collaborating center) |
| Antithrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC), in Collaboration With Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-4) [NCT04372589] | Phase 2/Phase 3 | 1,200 participants (Actual) | Interventional | 2020-05-20 | Completed |
| Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19: A Cluster Based Randomized Selection Trial (IMPROVE-COVID) [NCT04367831] | Phase 4 | 94 participants (Actual) | Interventional | 2020-05-02 | Completed |
| Effects of Different Concentrations of Pressurized-heparin Flushing Fluid on Coagulation and Platelet Function Monitored by the Sonoclot Analyzer [NCT04355273] | | 60 participants (Actual) | Interventional | 2018-01-24 | Completed |
| A Study to Assess the Effectiveness of Dry Cold Application on Pain Intensity and Bruise at the Subcutaneous Injection Site Among Patients Admitted in Selected Hospital [NCT03233321] | | 60 participants (Actual) | Interventional | 2015-11-30 | Completed |
| Bivalirudin vs Heparin in NSTEMI and STEMI in Patients on Modern Antiplatelet Therapy in SWEDEHEART A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on the SWEDEHEART Platform [NCT02311231] | Phase 4 | 6,012 participants (Actual) | Interventional | 2014-06-30 | Completed |
| A Study on the Impact of Bivalirudin Usage During Percutaneous Coronary Intervention for High-risk Plaques in the Coronary Artery on Post Percutaneous Coronary Intervention Coronary Microcirculation. [NCT05984537] | Phase 4 | 70 participants (Anticipated) | Interventional | 2023-07-01 | Active, not recruiting |
| Hemorrhage Following Small Polyp Resection in the Colon in Anticoagulated Patients: a Prospective Single-blinded Multicenter Study Comparing Warfarin vs. Low Molecular Weight Heparin Based Bridging Anticoagulation [NCT02375646] | | 286 participants (Anticipated) | Interventional | 2015-05-31 | Not yet recruiting |
| Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial [NCT04394377] | Phase 4 | 615 participants (Actual) | Interventional | 2020-06-21 | Completed |
| Heparins for Thromboprophylaxis in COVID-19 Patients: HETHICO Study in Veneto [NCT04393805] | | 744 participants (Actual) | Observational | 2020-06-01 | Completed |
| Observation and Treatment of Pulmonary Microthrombosis in Childhood Pneumonia With Elevated D-dimer [NCT04778917] | Phase 4 | 124 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants [NCT02664155] | Phase 3 | 203 participants (Actual) | Interventional | 2016-10-19 | Terminated(stopped due to recruiting difficulties) |
| Unfractionated Heparin in Acute Chest Syndrome: A Pilot Feasibility Randomized Controlled Trial of Unfractionated Heparin vs. Standard of Care in Acute Chest Syndrome [NCT02098993] | Phase 2 | 7 participants (Actual) | Interventional | 2014-05-31 | Terminated(stopped due to Poor enrollment.) |
| Study on the Application of a Novel Aspiration Thrombectomy Device Combined With Catheter-directed Thrombolysis for the Treatment of Acute Iliofemoral Deep Venous Thrombosis [NCT02414802] | | 40 participants (Anticipated) | Interventional | 2014-12-31 | Enrolling by invitation |
| Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease [NCT02651428] | Phase 3 | 806 participants (Actual) | Interventional | 2015-12-31 | Completed |
| Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices [NCT05545475] | | 100 participants (Anticipated) | Observational | 2022-01-01 | Recruiting |
| Determine the Safety/Efficacy of Ticagrelor in Post-transplant Patients With Hepatic Artery Thrombosis (HAT) [NCT04946929] | Phase 3 | 50 participants (Anticipated) | Interventional | 2021-07-31 | Not yet recruiting |
| Compare Effectiveness and Safety Utilizing 4% Sodium Citrate vs. Heparin as a Lock Solution in Central Venous Hemodialysis Catheter Among Hemodialysis Patients [NCT05188339] | Phase 2/Phase 3 | 120 participants (Anticipated) | Interventional | 2022-07-20 | Enrolling by invitation |
| Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial [NCT05944107] | Phase 4 | 65 participants (Actual) | Interventional | 2021-01-01 | Completed |
| Randomized Comparison of Anticoagulation After Primary Percutaneous Coronary Intervention Using Enoxaparin, ACT Guided Unfractionated Heparin or Bivalirudin Prolongation vs. no Anticoagulation To Improve Clinical Outcome [NCT03664180] | Phase 4 | 2,989 participants (Actual) | Interventional | 2019-01-11 | Completed |
| Concentration and Antibiotic Activity in Antibiotic Lock Solutions [NCT01592032] | Phase 4 | 125 participants (Anticipated) | Interventional | 2012-05-31 | Active, not recruiting |
| "Understanding Heparin Resistance in Cardiac Surgery: Altered Heparin Responsiveness and Its Association With Acute Inflammatory Reactions" [NCT01598883] | Phase 1 | 504 participants (Actual) | Interventional | 2012-06-30 | Completed |
| Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle. [NCT01924104] | Phase 3 | 400 participants (Anticipated) | Interventional | 2013-08-31 | Recruiting |
| The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension [NCT04397289] | Phase 1/Phase 2 | 70 participants (Actual) | Interventional | 2018-02-12 | Completed |
| Restart Anticoagulation in Patients With Spontaneous Intracerebral Hemorrhage and Mechanical Heart Valves [NCT04450446] | | 100 participants (Anticipated) | Observational | 2015-01-01 | Recruiting |
| Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial [NCT03425448] | | 192 participants (Anticipated) | Interventional | 2019-04-04 | Not yet recruiting |
| Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179] | | 27 participants (Actual) | Interventional | 2014-06-30 | Completed |
| Objective Assessment of Pulmonary Embolism Can be Deferred Without Increased Risk [NCT00381511] | Phase 4 | 300 participants | Interventional | 1999-01-31 | Completed |
| [NCT00004694] | | 24 participants | Interventional | 1994-01-31 | Completed |
| [NCT00005684] | | 0 participants | Observational | 1996-03-31 | Completed |
| A Phase Iv Trial To Assess The Effectiveness Of Apixaban Compared With Usual Care Anticoagulation In Subjects With Non-valvular Atrial Fibrillation Undergoing Cardioversion [NCT02100228] | Phase 4 | 1,500 participants (Actual) | Interventional | 2014-07-14 | Completed |
| Racial Differences in Vagal Control of Glucose Homeostasis [NCT02365285] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2015-03-31 | Completed |
| [NCT00000119] | Phase 2 | 0 participants | Interventional | 1994-03-31 | Active, not recruiting |
| Can Nebulised HepArin Reduce morTality and Time to Extubation in Patients With COVID-19 Requiring Mechanical Ventilation Meta-Trial (CHARTER-MT): Protocol for an Investigator-initiated International Meta-trial of Randomised Studies [NCT04545541] | Phase 2/Phase 3 | 300 participants (Anticipated) | Interventional | 2020-11-01 | Recruiting |
| Randomized, Double-Blind, Active-Controlled, Multicenter Trial of Abciximab And Bivalirudin in Patients With Non-ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Interventions (ISAR-REACT-4) [NCT00373451] | Phase 4 | 1,721 participants (Actual) | Interventional | 2006-07-31 | Completed |
| Biomarkers for Prediction of and Diagnosis of Ventilator-associated Pneumonia [NCT05117125] | | 1,000 participants (Anticipated) | Observational | 2021-10-15 | Recruiting |
| Release of TFPI by Anticoagulants in Cancer Patients by Standard or LMW Heparin [NCT00004875] | | 6 participants (Actual) | Observational | 1996-07-31 | Completed |
| Comparison of Heparin-based Wet Suction Method With Dry Suction Method in EUS Fine Needle Biopsy of Solid Pancreatic Mass [NCT04707560] | | 50 participants (Anticipated) | Interventional | 2020-01-01 | Recruiting |
| [NCT00370760] | Phase 3 | 0 participants | Interventional | 2006-09-30 | Recruiting |
| A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Evaluating Aspirin Versus Low-molecular-weight Heparin (LMWH) and Aspirin in Women With Antiphospholipid Syndrome and Pregnancy Loss [NCT03100123] | Early Phase 1 | 1 participants (Actual) | Interventional | 2017-11-06 | Terminated(stopped due to Pilot deemed not feasible by Steering Committee due to recruitment rate.) |
| Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial [NCT03143569] | | 20 participants (Actual) | Interventional | 2017-05-20 | Completed |
| Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese [NCT01780987] | Phase 3 | 80 participants (Actual) | Interventional | 2013-01-31 | Completed |
| The Use of Desirudin Versus Heparin for Thrombosis Prophylaxis in Cardiothoracic Surgery Patients [NCT00329433] | Phase 2/Phase 3 | 120 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Fat Induced Insulin Resistance and Atherosclerosis [NCT02348190] | | 86 participants (Actual) | Interventional | 2003-06-30 | Completed |
| In-Vitro Evaluation of Anticoagulant Therapy Management When Urgent Percutaneous Coronary Intervention is Required in Rivaroxaban-Treated Patients [NCT05541757] | | 30 participants (Actual) | Observational | 2021-01-01 | Completed |
| A Double-Blind, Randomized, Placebo-Controlled, Trial of Ethanol Lock Therapy for Treatment and Secondary Prophylaxis of Central Line Associated Bloodstream Infection (CLABSI) in Children and Adolescents [NCT01472965] | Phase 3 | 95 participants (Actual) | Interventional | 2011-12-29 | Completed |
| Efficacy and Safety of Nafamostat Mesylate for VV-ECMO Anticoagulation: a Randomized, Single-blind, Multicenter Exploratory, Heparin-controlled Trial [NCT05555641] | Phase 2 | 40 participants (Anticipated) | Interventional | 2022-12-20 | Recruiting |
| Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study) [NCT02454491] | Phase 4 | 418 participants (Actual) | Interventional | 2015-05-31 | Completed |
| A Phase 3b, Prospective, Randomized, Open-label, Blind Evaluator (PROBE) Study Evaluating the Efficacy and Safety of (LMW) Heparin/Edoxaban Versus Dalteparin in Venous Thromboembolism Associated With Cancer [NCT02073682] | Phase 3 | 1,046 participants (Actual) | Interventional | 2015-07-16 | Completed |
| A Proposal of a Prospective Study on Prevention of Pregnancy Loss in Women Carrying Inherited Thrombophilia [NCT02385461] | | 108 participants (Anticipated) | Observational [Patient Registry] | 2012-01-31 | Recruiting |
| Post-TIPS Short-term Low Molecular Weight Heparin for the Prevention of Early TIPS Dysfunction [NCT03171727] | | 117 participants (Anticipated) | Interventional | 2017-06-01 | Recruiting |
| Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort [NCT04979780] | | 3,708 participants (Actual) | Observational | 2021-07-20 | Completed |
| Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation [NCT03867851] | Phase 2 | 18 participants (Anticipated) | Interventional | 2021-02-08 | Recruiting |
| Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19) [NCT04655586] | Phase 2/Phase 3 | 160 participants (Actual) | Interventional | 2020-12-10 | Completed |
| The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss [NCT02990403] | Phase 4 | 500 participants (Anticipated) | Interventional | 2014-10-31 | Recruiting |
| Safety Profile of Innohep Versus Subcutaneous Unfractionated Heparin in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis [NCT00277394] | Phase 4 | 541 participants (Actual) | Interventional | 2005-12-31 | Completed |
| Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial [NCT01051778] | Phase 2 | 60 participants (Actual) | Interventional | 2006-06-30 | Completed |
| Evaluating Dose Regimen of Intravenous Unfractionated Heparin and Low Molecular Weight Heparin in Critical Ill Patients Versus Critical Ill COVID-19 Patients Using Anti-Xa Levels. [NCT05224388] | | 813 participants (Actual) | Observational | 2020-01-01 | Completed |
| An Investigator-initiated, Multicentre, Randomized, Trial Comparing Anticoagulation Alone Versus Transjugular Intrahepatic Portosystemic Shunt (TIPS) and Anticoagulation in Patients With Recent Obstructive Portal Vein Thrombosis [NCT03422419] | Phase 3 | 0 participants (Actual) | Interventional | 2018-08-01 | Withdrawn(stopped due to lack of funding) |
| A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients With Significant Hemorrhage Burden [NCT02501434] | Phase 2 | 88 participants (Anticipated) | Interventional | 2016-04-30 | Suspended |
| A Randomized, Open-label, Parallel Group Feasibility Study to Determine the Safety and Efficacy of M118 vs. Unfractionated Heparin (UFH) in Subjects With Stable Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (PCI) [NCT00543400] | Phase 2 | 503 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Demonstrated Study on Children Henoch-Schönlein Purpura Nephritis With Multistep Treatment of Traditional Chinese Medicine Combined Disease and Syndrome Differentiation [NCT03591471] | Phase 1/Phase 2 | 500 participants (Anticipated) | Interventional | 2014-09-30 | Recruiting |
| Prismaflex Therapeutic Plasma Exchange: Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation [NCT04351438] | | 108 participants (Actual) | Observational | 2012-01-31 | Active, not recruiting |
| ENDOvascular Interventions With AngioMAX: The ENDOMAX Trial [NCT01913483] | Phase 3 | 732 participants (Actual) | Interventional | 2013-09-24 | Terminated |
| Risk of Hemorrhage in Patients Prescribed Arixtra Compared to LMWH [NCT01064362] | | 13,442 participants (Actual) | Observational | 2010-01-31 | Completed |
| Effectiveness and Safety of Early Administration of Heparin at First Medical Contact for STEMI Patients Undergoing Primary Percutaneous Coronary Intervention: a Multicenter, Prospective, Randomized, Controlled Study [NCT05329155] | | 944 participants (Anticipated) | Interventional | 2022-07-20 | Recruiting |
| Safety and Efficacy of Argatroban Applicated in Anticoagulation of V-V ECMO: A Randomized Controlled Study [NCT04925167] | | 174 participants (Anticipated) | Interventional | 2021-07-06 | Recruiting |
| A Randomised Controlled Trial to Compare Unfractionated Heparin Versus Bivalirudin in the Treatment of Patients With a Clinical Diagnosis of ST-Segment Elevation Myocardial Infarction Events - For Planned Management With Primary PCI [NCT01519518] | Phase 4 | 1,829 participants (Actual) | Interventional | 2012-02-29 | Completed |
| Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation [NCT00721136] | | 104 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery [NCT00779558] | | 90 participants (Actual) | Interventional | 2005-11-30 | Completed |
| Anticoagulation Therapies Effect on the Endometrial Blood Flow and Pregnancy Outcomes in Unexplained Recurrent Implantation Failure Women [NCT03365466] | | 200 participants (Anticipated) | Observational | 2017-12-31 | Not yet recruiting |
| Prospective Randomized Trial of Autologous Platelet Rich Plasma in Reducing Allogeneic Transfusions During Aortic Surgery Under Deep Hypothermic Circulatory Arrest [NCT02513862] | | 80 participants (Actual) | Interventional | 2015-05-31 | Completed |
| Comparative Study of Conventional and Topical Heparin Treatments in Second Degree Burn Patients for Burn Analgesia and Duration of Wound Healing [NCT02497326] | | 36 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| The Efficacy of a Lock Solution Containing Taurolidine, Citrate and Heparin for the Prevention of Tunneled Central Line-associated Bloodstream Infections in Pediatric Oncology Patients, a Randomized Controlled, Mono-center Trial. [NCT05740150] | | 462 participants (Anticipated) | Interventional | 2020-10-27 | Recruiting |
| Venous Thromboembolic Prophylaxis After Major Trauma: A Randomized Controlled Trial of Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin [NCT01729559] | Phase 4 | 495 participants (Actual) | Interventional | 2012-11-30 | Completed |
| Clinical Efficacy of Product Alimax ® (Sodic Heparin) in Treatment of Burns: Comparative Study of Raw Materials Between Two Suppliers [NCT00701623] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2008-06-30 | Withdrawn |
| Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Early Anticoagulation With Rivaroxaban Versus Standard of Care in Determining Safety at 365 Days in Symptomatic Cerebral Venous Thrombosis [NCT03178864] | Phase 2 | 55 participants (Actual) | Interventional | 2019-03-12 | Completed |
| Streptokinase Versus Unfractionated Heparin Nebulization in Patients With Severe Acute Respiratory Distress Syndrome (ARDS): A Partially Randomized Controlled Trial [NCT03465085] | Phase 3 | 60 participants (Actual) | Interventional | 2016-02-18 | Completed |
| Coronary ARteriogenesis With Combined Heparin and EXercise Therapy in Chronic Refractory Angina [NCT03350737] | | 32 participants (Actual) | Interventional | 2013-02-01 | Completed |
| AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia [NCT05848713] | Phase 3 | 4,000 participants (Anticipated) | Interventional | 2023-10-10 | Recruiting |
| Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses [NCT01406795] | | 1 participants (Actual) | Interventional | 2010-12-31 | Terminated(stopped due to Poor enrollment and advances in venoplasty only techniques of the femoral vein) |
| Rate of Venous Thrombosis in Acutely Ill Patients Hospitalized in Internal Medicine Wards [NCT03157843] | | 1,000 participants (Anticipated) | Observational | 2015-02-28 | Recruiting |
| A Randomized, Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery [NCT04767113] | | 35 participants (Actual) | Interventional | 2021-03-01 | Completed |
| Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: A Randomized Controlled Trial [NCT05886998] | Phase 3 | 100 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting |
| Role of Fatty Acid Oxidation Defects in Insulin Sensitivity [NCT02517307] | | 52 participants (Actual) | Interventional | 2016-02-29 | Completed |
| Heparin Versus Taurolidine to Bloodstream Infection Prevention Related in Central Venous Catheter in Children With Intestinal Failure [NCT02515201] | Phase 4 | 20 participants (Anticipated) | Interventional | 2014-09-30 | Active, not recruiting |
| Comparison of Clinical Pregnancy Rates Between Two Protocols, With or Without Low Molecular Weight Heparin Administration Before Frozen Embryo Transfer in Hormonal Replacement Cycles: a Prospective Randomized Controlled Trial [NCT03120715] | Phase 4 | 342 participants (Anticipated) | Interventional | 2016-07-01 | Recruiting |
| Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial [NCT05067153] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-05-01 | Recruiting |
| Prospective Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Indicate the Presence and Outcome of Sepsis in Patients With Suspected Infection Following Emergency Department Admission [NCT03295825] | | 400 participants (Actual) | Interventional | 2017-09-22 | Completed |
| The Effect on Bruising and Pain of Different Durations of Pressure Application Following Subcutaneous Heparin Injection to the Upper Arm [NCT06076434] | | 50 participants (Actual) | Interventional | 2022-11-01 | Completed |
| An Open-label, Randomized, 2-part, Parallel Design Study to Characterize the Effect of Heparin on Palifermin Pharmacokinetics and the Effect of Palifermin on Heparin Pharmacodynamics in Healthy Subjects [NCT00361348] | Phase 1 | 45 participants | Interventional | 2005-12-31 | Completed |
| A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts. [NCT01601873] | | 103 participants (Actual) | Interventional | 2012-11-09 | Terminated(stopped due to Results from futility analysis conducted at planned interim time-point did not meet the study criteria for continuation.) |
| Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine [NCT02986594] | Phase 4 | 600 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00277394 (3) [back to overview] | Number of Patients With Recurrence of Venous Thromboembolism |
| NCT00277394 (3) [back to overview] | Number of Patients With Major Bleeding Events |
| NCT00277394 (3) [back to overview] | Number of Patients With Clinically Relevant Bleeding Events |
| NCT00329433 (3) [back to overview] | The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery. |
| NCT00329433 (3) [back to overview] | The Incidence of Bleeding in Each Group. |
| NCT00329433 (3) [back to overview] | The Incidence of DVTs in Each Group. |
| NCT00433966 (7) [back to overview] | Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events |
| NCT00433966 (7) [back to overview] | Pharmacology Arm - Non-Coronary Artery Bypass Grafting-Related Major Bleeding |
| NCT00433966 (7) [back to overview] | Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis |
| NCT00433966 (7) [back to overview] | Stent Arm - Ischemic Target Lesion Revascularization |
| NCT00433966 (7) [back to overview] | Stent Arm - Segment Binary Angiographic Restenosis |
| NCT00433966 (7) [back to overview] | Pharmacology Arm - Major Adverse Cardiovascular Events |
| NCT00433966 (7) [back to overview] | Pharmacology Arm - Major Adverse Cardiovascular Events |
| NCT00435487 (6) [back to overview] | Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days |
| NCT00435487 (6) [back to overview] | Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria |
| NCT00435487 (6) [back to overview] | Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization |
| NCT00435487 (6) [back to overview] | Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30 |
| NCT00435487 (6) [back to overview] | Number of Subjects With Stroke |
| NCT00435487 (6) [back to overview] | Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization |
| NCT00445211 (5) [back to overview] | Hospital Death During the Index Hospitalization |
| NCT00445211 (5) [back to overview] | Intra-aortic Balloon Pump-related Death During the Index Hospitalization |
| NCT00445211 (5) [back to overview] | Major Bleeding During the Index Hospitalization |
| NCT00445211 (5) [back to overview] | Major Ischemia (Decreased Blood Flow) During the Index Hospitalization |
| NCT00445211 (5) [back to overview] | Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization |
| NCT00445328 (7) [back to overview] | Confirmed Thromboembolic Events |
| NCT00445328 (7) [back to overview] | Composite of Objectively Verified Thromboembolic Events |
| NCT00445328 (7) [back to overview] | Bleeding - Major or Minor |
| NCT00445328 (7) [back to overview] | Thrombocytopenia |
| NCT00445328 (7) [back to overview] | Stroke - Ischemic or Hemorrhagic |
| NCT00445328 (7) [back to overview] | Allergic Reactions (Drug-related) |
| NCT00445328 (7) [back to overview] | All Cause Mortality |
| NCT00464087 (4) [back to overview] | The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge |
| NCT00464087 (4) [back to overview] | The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge |
| NCT00464087 (4) [back to overview] | The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge |
| NCT00464087 (4) [back to overview] | Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis |
| NCT00508924 (2) [back to overview] | Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment. |
| NCT00508924 (2) [back to overview] | Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay. |
| NCT00541307 (5) [back to overview] | Primary Assisted Patency |
| NCT00541307 (5) [back to overview] | Primary Patency at 12 Months |
| NCT00541307 (5) [back to overview] | Proportion of Subjects Who Experience Major Device-related Adverse Events Within the First 30 Days |
| NCT00541307 (5) [back to overview] | Secondary Patency |
| NCT00541307 (5) [back to overview] | Device-related Major Adverse Events at 12 Months |
| NCT00543400 (1) [back to overview] | Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding. |
| NCT00571259 (2) [back to overview] | Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow |
| NCT00571259 (2) [back to overview] | Rate of Device-related Bacteremia |
| NCT00577096 (10) [back to overview] | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) |
| NCT00577096 (10) [back to overview] | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term) |
| NCT00577096 (10) [back to overview] | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) |
| NCT00577096 (10) [back to overview] | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) |
| NCT00577096 (10) [back to overview] | Total Number of Days of Stem Cell Collection (Short Term) |
| NCT00577096 (10) [back to overview] | Total Number of Days of Stem Cell Collection (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Stem Cell Collection Attempts (Short Term) |
| NCT00577096 (10) [back to overview] | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Stem Cell Collection Attempts (Long Term) |
| NCT00577096 (10) [back to overview] | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) |
| NCT00680459 (3) [back to overview] | Recurrence of Central Venous Line Infection Within 35 Days of Enrollment |
| NCT00680459 (3) [back to overview] | Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study |
| NCT00680459 (3) [back to overview] | Clearance of Central Venous Line Infection by Day 6 of Study |
| NCT00721136 (3) [back to overview] | Thromboembolic Events |
| NCT00721136 (3) [back to overview] | Bleeding Complication |
| NCT00721136 (3) [back to overview] | Anticoagulant Related Complications |
| NCT00779558 (5) [back to overview] | Need for Antibiotics |
| NCT00779558 (5) [back to overview] | Thrombosis |
| NCT00779558 (5) [back to overview] | Total PRBCs Transfused |
| NCT00779558 (5) [back to overview] | Days to Extubation |
| NCT00779558 (5) [back to overview] | Cardiac ICU Length of Stay |
| NCT00790842 (6) [back to overview] | Worst Degree Treatment-Related Adverse Events Across All Event Types Per Patient |
| NCT00790842 (6) [back to overview] | Progression-free Survival |
| NCT00790842 (6) [back to overview] | Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR] |
| NCT00790842 (6) [back to overview] | Overall Survival Time |
| NCT00790842 (6) [back to overview] | Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy |
| NCT00790842 (6) [back to overview] | Duration of Response |
| NCT00790907 (8) [back to overview] | Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30 |
| NCT00790907 (8) [back to overview] | Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period |
| NCT00790907 (8) [back to overview] | Number of Participants With Major Bleeding During the Peri-PCI Period |
| NCT00790907 (8) [back to overview] | Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period |
| NCT00790907 (8) [back to overview] | Number of Participants With Minor Bleeding During the Peri-PCI Period |
| NCT00790907 (8) [back to overview] | Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30 |
| NCT00790907 (8) [back to overview] | Number of Participants With Major PCI-related Procedural Complications |
| NCT00790907 (8) [back to overview] | Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30 |
| NCT00818753 (5) [back to overview] | Percentage of Participants Who Experienced Catheter Related Thrombi Requiring Rescue Anticoagulation Therapy |
| NCT00818753 (5) [back to overview] | Percentage of Participants Who Require Anticoagulation and/or Have Clinical Signs of Catheter Related Thrombosis |
| NCT00818753 (5) [back to overview] | Percentage of Participants Who Experienced Catheter Related Thrombi Not Resulting in Clinical Complications Including Guide-catheter (Wire) Thrombosis |
| NCT00818753 (5) [back to overview] | Number of Participants With Bleeding Events |
| NCT00818753 (5) [back to overview] | Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow |
| NCT00911157 (5) [back to overview] | Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) |
| NCT00911157 (5) [back to overview] | Percentage of Participants With a Bleeding Event |
| NCT00911157 (5) [back to overview] | Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline |
| NCT00911157 (5) [back to overview] | Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type) |
| NCT00911157 (5) [back to overview] | Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10 |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event |
| NCT00911300 (10) [back to overview] | Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days |
| NCT00911300 (10) [back to overview] | Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm |
| NCT00911300 (10) [back to overview] | Number of Participants Who Were Re-hospitalized |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event |
| NCT00911300 (10) [back to overview] | Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause |
| NCT00911300 (10) [back to overview] | Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE |
| NCT00948441 (2) [back to overview] | Safety, Side Effects |
| NCT00948441 (2) [back to overview] | Number of Episodes of Catheter Related Blood Stream Infections in Each Study Period. |
| NCT00981409 (5) [back to overview] | The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse |
| NCT00981409 (5) [back to overview] | The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type) |
| NCT00981409 (5) [back to overview] | Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10 |
| NCT00981409 (5) [back to overview] | The Percentage of Participants With a Bleeding Event |
| NCT00981409 (5) [back to overview] | The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE) |
| NCT00986154 (3) [back to overview] | Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE |
| NCT00986154 (3) [back to overview] | Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment |
| NCT00986154 (3) [back to overview] | The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality |
| NCT01051778 (1) [back to overview] | Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) |
| NCT01064362 (2) [back to overview] | Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL) |
| NCT01064362 (2) [back to overview] | Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL) |
| NCT01087723 (9) [back to overview] | The Incidence of Thrombocytopenia |
| NCT01087723 (9) [back to overview] | The Incidence of Death, Re-infarction, Non-CABG-related Major Bleeding, or Ischemia-driven Revascularization (IDR) |
| NCT01087723 (9) [back to overview] | The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO) |
| NCT01087723 (9) [back to overview] | The Incidence of Minor Bleeding: TIMI and GUSTO |
| NCT01087723 (9) [back to overview] | The Incidence of Stroke |
| NCT01087723 (9) [back to overview] | The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition]) |
| NCT01087723 (9) [back to overview] | The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding |
| NCT01087723 (9) [back to overview] | The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding |
| NCT01087723 (9) [back to overview] | The Incidence of Death at 1 Year |
| NCT01163097 (22) [back to overview] | Subject Incidence of Proteinuria |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Protein/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Protein/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Protein/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Protein/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Lipase. |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue. |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Amylase |
| NCT01163097 (22) [back to overview] | Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL) |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Albumin/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Albumin/Creatinine |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: Vss |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: Estimated Concentration at Time 0 (C0) |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: CL |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: C0 |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: AUC (0-24) |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24) |
| NCT01163097 (22) [back to overview] | Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss) |
| NCT01163097 (22) [back to overview] | Incidence of Grade 2 or Higher Specific Skin-related Adverse Events. |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Albumin/Creatinine |
| NCT01163097 (22) [back to overview] | Ratio to Baseline of Albumin/Creatinine |
| NCT01163097 (22) [back to overview] | Subject Incidence of Treatment-emergent Adverse Event |
| NCT01166997 (2) [back to overview] | Reduction of RV/LV Ratio |
| NCT01166997 (2) [back to overview] | Major Bleeding and Intracranial Bleeding at 30 Days. |
| NCT01318811 (2) [back to overview] | Filter Life |
| NCT01318811 (2) [back to overview] | Number of Major Bleeding Complications |
| NCT01406795 (9) [back to overview] | VEINS-QOL |
| NCT01406795 (9) [back to overview] | Stent Migration |
| NCT01406795 (9) [back to overview] | Stent Migration |
| NCT01406795 (9) [back to overview] | Secondary Patency |
| NCT01406795 (9) [back to overview] | Primary Patency Rate |
| NCT01406795 (9) [back to overview] | Freedom From Device-related Amputation |
| NCT01406795 (9) [back to overview] | Decrease in Swelling of Affected Extremity |
| NCT01406795 (9) [back to overview] | Assisted-primary Patency |
| NCT01406795 (9) [back to overview] | Adverse Events |
| NCT01472965 (6) [back to overview] | Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone |
| NCT01472965 (6) [back to overview] | Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone |
| NCT01472965 (6) [back to overview] | Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone |
| NCT01472965 (6) [back to overview] | Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone |
| NCT01472965 (6) [back to overview] | Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone |
| NCT01472965 (6) [back to overview] | Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone |
| NCT01519518 (4) [back to overview] | Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization |
| NCT01519518 (4) [back to overview] | Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition |
| NCT01519518 (4) [back to overview] | Stent Thrombosis Rate (ARC Definite or Probable) |
| NCT01519518 (4) [back to overview] | Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition |
| NCT01520454 (8) [back to overview] | Change in Circulating Leptin Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Insulin Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Glucose Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Ghrelin Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Adiponectin Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels |
| NCT01520454 (8) [back to overview] | Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels |
| NCT01601873 (8) [back to overview] | Primary Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Primary Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Primary-Assisted Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Primary-Assisted Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Secondary Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Secondary Graft Patency Rate |
| NCT01601873 (8) [back to overview] | Number of Participants With Complications or Morbidity Attributable to the Study |
| NCT01601873 (8) [back to overview] | Number of Postoperative Re-interventions |
| NCT01651780 (12) [back to overview] | Major Vascular Complications |
| NCT01651780 (12) [back to overview] | New Onset Atrial Fibrillation/Flutter |
| NCT01651780 (12) [back to overview] | Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge |
| NCT01651780 (12) [back to overview] | Acute Kidney Injury |
| NCT01651780 (12) [back to overview] | Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor |
| NCT01651780 (12) [back to overview] | Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke |
| NCT01651780 (12) [back to overview] | Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS) |
| NCT01651780 (12) [back to overview] | Transient Ischemic Attack |
| NCT01651780 (12) [back to overview] | NACE at 48 Hours or Before Hospital Discharge |
| NCT01651780 (12) [back to overview] | Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge |
| NCT01651780 (12) [back to overview] | Net Adverse Clinical Events (NACE) at up to 30 Days |
| NCT01651780 (12) [back to overview] | Acquired Thrombocytopenia |
| NCT01662908 (5) [back to overview] | Number of Participants With Major Adverse Cardiovascular Events (MACE) |
| NCT01662908 (5) [back to overview] | Number of Participants With Clinically Relevant Bleeding |
| NCT01662908 (5) [back to overview] | Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel |
| NCT01662908 (5) [back to overview] | Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method] |
| NCT01662908 (5) [back to overview] | Number of Participants With Recurrence of Venous Thromboembolism (VTE) |
| NCT01729559 (4) [back to overview] | Pulmonary Embolus |
| NCT01729559 (4) [back to overview] | Lower Extremity Deep Vein Thrombosis |
| NCT01729559 (4) [back to overview] | Heparin Induced Thrombocytopenia |
| NCT01729559 (4) [back to overview] | Bleeding Event |
| NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE) |
| NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT) |
| NCT01780987 (6) [back to overview] | Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period |
| NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period |
| NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period |
| NCT01780987 (6) [back to overview] | Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods |
| NCT01913483 (3) [back to overview] | Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration |
| NCT01913483 (3) [back to overview] | Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30 |
| NCT01913483 (3) [back to overview] | Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC) |
| NCT01976988 (6) [back to overview] | Number of Participants With Bleeding Complications |
| NCT01976988 (6) [back to overview] | Number of Participants With Postoperative VTE Within 48 Hours After Surgery |
| NCT01976988 (6) [back to overview] | Hospital Stay |
| NCT01976988 (6) [back to overview] | Number of Participants With Surgical Complications |
| NCT01976988 (6) [back to overview] | Number of Participants With VTE Within 30-day After Surgery |
| NCT01976988 (6) [back to overview] | Number of Participants With Postoperative Thrombocytopenia |
| NCT01999179 (5) [back to overview] | PTS Assessment Completion |
| NCT01999179 (5) [back to overview] | Number of Participants With Post-thrombotic Syndrome |
| NCT01999179 (5) [back to overview] | Biomarker Sample Collection |
| NCT01999179 (5) [back to overview] | Number of Participants With Major Bleeding |
| NCT01999179 (5) [back to overview] | Number of Participants With Recurrent Thrombosis |
| NCT02056782 (2) [back to overview] | Number of Subjects Who Achieved a Morphologic Complete Remission |
| NCT02056782 (2) [back to overview] | Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion) |
| NCT02073682 (7) [back to overview] | Number of Participants With Adjudicated Major Bleeding Events While on Treatment |
| NCT02073682 (7) [back to overview] | Number of Participants With VTE-Related Death |
| NCT02073682 (7) [back to overview] | Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death |
| NCT02073682 (7) [back to overview] | Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period |
| NCT02073682 (7) [back to overview] | Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period |
| NCT02073682 (7) [back to overview] | Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period |
| NCT02073682 (7) [back to overview] | Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event |
| NCT02098993 (10) [back to overview] | Opioid Administration Per Participant |
| NCT02098993 (10) [back to overview] | Duration of Fever Assessed by Body Temperature |
| NCT02098993 (10) [back to overview] | Time to Hospital Discharge |
| NCT02098993 (10) [back to overview] | Units of Red Blood Cells Administered |
| NCT02098993 (10) [back to overview] | Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain |
| NCT02098993 (10) [back to overview] | Duration of Hypoxemia Assessed by Arterial Oxygen Saturation |
| NCT02098993 (10) [back to overview] | Percentage of Participants Requiring Mechanical Ventilation |
| NCT02098993 (10) [back to overview] | Percentage of Participants Transferred to Intensive Care Unit |
| NCT02098993 (10) [back to overview] | Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome |
| NCT02098993 (10) [back to overview] | Duration of Leukocytosis Assessed by White Blood Cell Count |
| NCT02100228 (11) [back to overview] | Number of Participants With Different Type of Cardioversion Events |
| NCT02100228 (11) [back to overview] | Duration of Hospital Stay of Participants |
| NCT02100228 (11) [back to overview] | Number of Participants Who Used Image Guidance Approach |
| NCT02100228 (11) [back to overview] | Number of Participants With Acute Stroke Event |
| NCT02100228 (11) [back to overview] | Number of Participants With All Cause Death |
| NCT02100228 (11) [back to overview] | Number of Participants With Clinically Relevant Non-Major Bleeding Events |
| NCT02100228 (11) [back to overview] | Number of Participants With Major Bleeding Event |
| NCT02100228 (11) [back to overview] | Number of Participants With Systemic Embolism Event |
| NCT02100228 (11) [back to overview] | Time to First Attempt of Cardioversion |
| NCT02100228 (11) [back to overview] | Number of Cardioversion Attempt of Participants |
| NCT02100228 (11) [back to overview] | Number of Participants With Their Rhythm Status |
| NCT02227329 (1) [back to overview] | Number of Catheter-Related Blood Stream Infections |
| NCT02365285 (2) [back to overview] | Change in Oxidative Stress: Baseline to 4 Hours |
| NCT02365285 (2) [back to overview] | Change in Oxidative Stress: Baseline to 2 Hours |
| NCT02565147 (9) [back to overview] | CMR Assessment Of LVEF At Day 90 |
| NCT02565147 (9) [back to overview] | TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI |
| NCT02565147 (9) [back to overview] | CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5 |
| NCT02565147 (9) [back to overview] | Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5 |
| NCT02565147 (9) [back to overview] | CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5 |
| NCT02565147 (9) [back to overview] | CMR Assessment Of Infarct Size At Day 5 |
| NCT02565147 (9) [back to overview] | CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5 |
| NCT02565147 (9) [back to overview] | Index Of Microcirculatory Resistance (IMR) |
| NCT02565147 (9) [back to overview] | Death At Day 90 |
| NCT02651428 (2) [back to overview] | Presence of a CAC-Adjudicated Catheter-Related Bloodstream Infection (CRBSI) in Subjects Receiving Hemodialysis for the Treatment of End Stage Renal Disease (ESRD): Final Analysis |
| NCT02651428 (2) [back to overview] | Participants With a Study Catheter Removal for Any Reason |
| NCT02653092 (2) [back to overview] | Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration |
| NCT02653092 (2) [back to overview] | Change in Steady State Amount of Glucose Metabolized at the Set Insulin Infusion Rate Under Euglycemic Conditions |
| NCT02755818 (5) [back to overview] | C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups |
| NCT02755818 (5) [back to overview] | LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups |
| NCT02755818 (5) [back to overview] | HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups |
| NCT02755818 (5) [back to overview] | Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups |
| NCT02755818 (5) [back to overview] | Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups |
| NCT02774265 (3) [back to overview] | Number of Participants With Pulmonary Embolism Events |
| NCT02774265 (3) [back to overview] | Number of Participants With Treatment-related Bleeding Events as Assessed by the Need for Blood Transfusions and Procedures for Bleeding Complications After Initiation of the Study Medication. |
| NCT02774265 (3) [back to overview] | Number of Participants With Deep Venous Thromboembolism |
| NCT02798471 (14) [back to overview] | Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment |
| NCT02798471 (14) [back to overview] | Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment |
| NCT02798471 (14) [back to overview] | Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) |
| NCT02798471 (14) [back to overview] | Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated) |
| NCT02798471 (14) [back to overview] | Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite) |
| NCT02798471 (14) [back to overview] | Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint) |
| NCT02873338 (10) [back to overview] | Duration of Event-free Survival |
| NCT02873338 (10) [back to overview] | Number of Subjects Who Achieved Morphologic Complete Remission |
| NCT02873338 (10) [back to overview] | Duration of Morphologic Complete Remission |
| NCT02873338 (10) [back to overview] | Number of Subjects Who Died by Day 30 |
| NCT02873338 (10) [back to overview] | Time to Platelet Recovery |
| NCT02873338 (10) [back to overview] | Number of Subjects Who Died by Day 60. |
| NCT02873338 (10) [back to overview] | Number of Subjects Who Died by Day 90 |
| NCT02873338 (10) [back to overview] | Time to Leukemia-free Survival |
| NCT02873338 (10) [back to overview] | Time to Recovery of Neutrophils |
| NCT02873338 (10) [back to overview] | Number of Subjects Who Achieved Composite Complete Remission |
| NCT02970032 (2) [back to overview] | Number of Rate Adjustments |
| NCT02970032 (2) [back to overview] | Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL) |
| NCT02981472 (15) [back to overview] | The Number of Participants With Adjudicated CRNM Bleeding |
| NCT02981472 (15) [back to overview] | The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death |
| NCT02981472 (15) [back to overview] | The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL) |
| NCT02981472 (15) [back to overview] | Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score |
| NCT02981472 (15) [back to overview] | The Number of Participants With Adjudicated Major Bleeding |
| NCT02981472 (15) [back to overview] | Chromogenic FX Assay (Apparent FX Level) |
| NCT02981472 (15) [back to overview] | Anti-FXa Activity |
| NCT02981472 (15) [back to overview] | Trough Observed Concentration (Cmin) |
| NCT02981472 (15) [back to overview] | Time of Maximum Observed Concentration (Tmax) |
| NCT02981472 (15) [back to overview] | The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding |
| NCT02981472 (15) [back to overview] | The Number of Participants With All Adjudicated Bleeding |
| NCT02981472 (15) [back to overview] | The Number of Participant Deaths in the Study |
| NCT02981472 (15) [back to overview] | Maximum Observed Concentration (Cmax) |
| NCT02981472 (15) [back to overview] | Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events |
| NCT02981472 (15) [back to overview] | Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU)) |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu |
| NCT03000673 (22) [back to overview] | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.) |
| NCT03000673 (22) [back to overview] | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes |
| NCT03000673 (22) [back to overview] | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Cmax |
| NCT03000673 (22) [back to overview] | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function |
| NCT03000673 (22) [back to overview] | The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Vital Signs: Heart Rate (Beats/Min) |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Vital Signs: Diastolic Blood Pressure |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg) |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Tmax |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7) |
| NCT03000673 (22) [back to overview] | The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate |
| NCT03000673 (22) [back to overview] | The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24) |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: fu |
| NCT03000673 (22) [back to overview] | Pharmacokinetic Parameters of BMS-986177: Cmaxfu |
| NCT03000673 (22) [back to overview] | The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing |
| NCT03006562 (7) [back to overview] | Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms |
| NCT03006562 (7) [back to overview] | Estimated Blood Loss During Surgery |
| NCT03006562 (7) [back to overview] | Number of Participants With Major Postoperative Bleeding |
| NCT03006562 (7) [back to overview] | Number of Participants With Occurrence of Any Venous Thromboembolism |
| NCT03006562 (7) [back to overview] | Number of Participants With Symptomatic Postoperative Fluid Collection |
| NCT03006562 (7) [back to overview] | Number of Participants With Symptomatic Venous Thromboembolism |
| NCT03006562 (7) [back to overview] | Surgical Drain Output After Surgery |
| NCT03100123 (7) [back to overview] | Consent |
| NCT03100123 (7) [back to overview] | Crossover Rate |
| NCT03100123 (7) [back to overview] | Eligibility |
| NCT03100123 (7) [back to overview] | Withdrawals/Loss to Follow-up |
| NCT03100123 (7) [back to overview] | Study Feasibility: Mean Recruitment Rate Per Center Per Month |
| NCT03100123 (7) [back to overview] | Study Drug Compliance |
| NCT03100123 (7) [back to overview] | Essential Documents |
| NCT03143569 (8) [back to overview] | Nomogram Feasibility |
| NCT03143569 (8) [back to overview] | Dosing Changes |
| NCT03143569 (8) [back to overview] | Success of Nomogram |
| NCT03143569 (8) [back to overview] | Time to Therapeutic Dose |
| NCT03143569 (8) [back to overview] | Nomogram Feasibility |
| NCT03143569 (8) [back to overview] | Nomogram Feasibility |
| NCT03143569 (8) [back to overview] | Nomogram Feasibility |
| NCT03143569 (8) [back to overview] | Nomogram Feasibility |
| NCT03318393 (3) [back to overview] | Number of Blood Products Transfused |
| NCT03318393 (3) [back to overview] | Percentage of Time Spent at Goal Anticoagulation |
| NCT03318393 (3) [back to overview] | Number of Participants With One or More Major Bleeding Events |
| NCT03395639 (8) [back to overview] | Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period |
| NCT03395639 (8) [back to overview] | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period |
| NCT03395639 (8) [back to overview] | Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period |
| NCT03395639 (8) [back to overview] | Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period |
| NCT03395639 (8) [back to overview] | Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period |
| NCT03395639 (8) [back to overview] | Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period |
| NCT03395639 (8) [back to overview] | Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period |
| NCT03395639 (8) [back to overview] | Number of Participants With Adjudicated Bleeding Events During the Extension Period |
| NCT03672006 (5) [back to overview] | Off Study Use of t-PA |
| NCT03672006 (5) [back to overview] | Episodes of CVC Dysfunction |
| NCT03672006 (5) [back to overview] | Clinical Bleeding |
| NCT03672006 (5) [back to overview] | Catheter-associated Venous Thrombosis |
| NCT03672006 (5) [back to overview] | Catheter-associated Bloodstream Infection |
| NCT03772613 (3) [back to overview] | Adverse Clinical Events |
| NCT03772613 (3) [back to overview] | Bleeding |
| NCT03772613 (3) [back to overview] | Stent Thrombosis |
| NCT03862755 (2) [back to overview] | Provider Adherence in Implementation of PE Prevention Strategies. |
| NCT03862755 (2) [back to overview] | Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies. |
| NCT03894904 (3) [back to overview] | Number of Participants With Suboptimal Waveforms Who Received Rescue Papaverine and for Whom Papaverine Rescued Suboptimal Waveforms |
| NCT03894904 (3) [back to overview] | Number of Participants With Optimal Arterial Waveform |
| NCT03894904 (3) [back to overview] | Number of Participants With Optimal Arterial Waveform |
| NCT04042324 (6) [back to overview] | Iron Profile as Measured by the AUC (Area Under the Curve) 0-t |
| NCT04042324 (6) [back to overview] | TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours |
| NCT04042324 (6) [back to overview] | Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration) |
| NCT04042324 (6) [back to overview] | aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours |
| NCT04042324 (6) [back to overview] | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t |
| NCT04042324 (6) [back to overview] | Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours |
| NCT04355728 (50) [back to overview] | Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG |
| NCT04355728 (50) [back to overview] | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
| NCT04355728 (50) [back to overview] | Survival at 60 Days Post First Infusion |
| NCT04355728 (50) [back to overview] | Survival at 31 Days Post First Infusion |
| NCT04355728 (50) [back to overview] | Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) |
| NCT04355728 (50) [back to overview] | Carbon Dioxide (CO2) |
| NCT04355728 (50) [back to overview] | Calcium |
| NCT04355728 (50) [back to overview] | Number of Subjects With Serious Adverse Events by 31 Days After First Infusion |
| NCT04355728 (50) [back to overview] | Alkaline Phosphatase |
| NCT04355728 (50) [back to overview] | 25-Hydroxy Vitamin D Levels |
| NCT04355728 (50) [back to overview] | Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) |
| NCT04355728 (50) [back to overview] | Albumin |
| NCT04355728 (50) [back to overview] | Lymphocytes |
| NCT04355728 (50) [back to overview] | Neutrophils |
| NCT04355728 (50) [back to overview] | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion |
| NCT04355728 (50) [back to overview] | Sodium |
| NCT04355728 (50) [back to overview] | Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio |
| NCT04355728 (50) [back to overview] | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion |
| NCT04355728 (50) [back to overview] | Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion |
| NCT04355728 (50) [back to overview] | Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) |
| NCT04355728 (50) [back to overview] | Blood Urea Nitrogen (BUN) |
| NCT04355728 (50) [back to overview] | Glomerular Filtration Rate |
| NCT04355728 (50) [back to overview] | C-Reactive Protein Levels |
| NCT04355728 (50) [back to overview] | Oxygenation Index (OI) |
| NCT04355728 (50) [back to overview] | Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 |
| NCT04355728 (50) [back to overview] | Platelets Count |
| NCT04355728 (50) [back to overview] | Potassium |
| NCT04355728 (50) [back to overview] | Respiratory Rate and Oxygenation Index (ROX Index) |
| NCT04355728 (50) [back to overview] | Sequential Organ Failure Assessment (SOFA) Scores |
| NCT04355728 (50) [back to overview] | Hematocrit |
| NCT04355728 (50) [back to overview] | Glucose |
| NCT04355728 (50) [back to overview] | D-dimer Levels |
| NCT04355728 (50) [back to overview] | Creatinine |
| NCT04355728 (50) [back to overview] | Total Bilirubin |
| NCT04355728 (50) [back to overview] | Chloride |
| NCT04355728 (50) [back to overview] | Total Protein |
| NCT04355728 (50) [back to overview] | Tumor Necrosis Factor-alpha (TNFα) |
| NCT04355728 (50) [back to overview] | Tumor Necrosis Factor-beta (TNFβ) |
| NCT04355728 (50) [back to overview] | Ventilator-Free Days Throughout 28 Days Post Second Infusion |
| NCT04355728 (50) [back to overview] | Ventilator-Free Days Throughout 90 Days |
| NCT04355728 (50) [back to overview] | Viral Load by SARS-CoV-2 RT-PCR |
| NCT04355728 (50) [back to overview] | White Blood Cell Count (WBC) |
| NCT04355728 (50) [back to overview] | Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity |
| NCT04355728 (50) [back to overview] | Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment |
| NCT04355728 (50) [back to overview] | Number of Participants With Pre-Specified Infusion Associated Adverse Events |
| NCT04355728 (50) [back to overview] | Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) |
| NCT04355728 (50) [back to overview] | Subjects With Adverse Events and Serious Adverse Events by Severity |
| NCT04355728 (50) [back to overview] | Hemogoblin |
| NCT04355728 (50) [back to overview] | Subjects With Adverse Events by Relatedness to Treatment |
| NCT04355728 (50) [back to overview] | Time to Recovery |
| NCT04389840 (1) [back to overview] | Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28 |
| NCT04401293 (7) [back to overview] | Re-hospitalization |
| NCT04401293 (7) [back to overview] | Major Bleeding |
| NCT04401293 (7) [back to overview] | Progression to Acute Respiratory Distress Syndrome (ARDS) |
| NCT04401293 (7) [back to overview] | Sepsis-induced Coagulopathy (SIC) Score |
| NCT04401293 (7) [back to overview] | Need for Intubation |
| NCT04401293 (7) [back to overview] | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days. |
| NCT04401293 (7) [back to overview] | Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4 |
| NCT04406389 (4) [back to overview] | Number of Major and Clinically Relevant Non-major Bleeding Events |
| NCT04406389 (4) [back to overview] | Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events |
| NCT04406389 (4) [back to overview] | 30-day Mortality |
| NCT04406389 (4) [back to overview] | Length of Intensive Care Unit (ICU) Stay in Days |
| NCT04419493 (3) [back to overview] | Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) |
| NCT04419493 (3) [back to overview] | Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax) |
| NCT04419493 (3) [back to overview] | Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞) |
| NCT04466618 (1) [back to overview] | Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39 |
| NCT04490239 (9) [back to overview] | Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14 |
| NCT04490239 (9) [back to overview] | Number of Incidents of Epistaxis, Acute Phase |
| NCT04490239 (9) [back to overview] | Number of Incidents of Epistaxis, Chronic Phase |
| NCT04490239 (9) [back to overview] | Other Adverse Effects, Acute Phase |
| NCT04490239 (9) [back to overview] | Other Adverse Effects, Chronic Phase |
| NCT04490239 (9) [back to overview] | Percent Change in Platelet Count From Pre-dose Baseline |
| NCT04490239 (9) [back to overview] | Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2 |
| NCT04490239 (9) [back to overview] | Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14 |
| NCT04490239 (9) [back to overview] | Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15 |
| NCT04635839 (10) [back to overview] | Maximum Anti-Factor Xa Level Measured |
| NCT04635839 (10) [back to overview] | Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism) |
| NCT04635839 (10) [back to overview] | Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin |
| NCT04635839 (10) [back to overview] | Number of Participants That Received a Blood Transfusion |
| NCT04635839 (10) [back to overview] | Number of Participants That Received General Anesthesia |
| NCT04635839 (10) [back to overview] | Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin |
| NCT04635839 (10) [back to overview] | Maximum Activated Partial Thromboplastin Clotting Time Levels Measured |
| NCT04635839 (10) [back to overview] | Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds). |
| NCT04635839 (10) [back to overview] | Mode of Delivery |
| NCT04635839 (10) [back to overview] | Estimated Blood Loss From Delivery |
| NCT04655586 (8) [back to overview] | Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b) |
| NCT04655586 (8) [back to overview] | Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b) |
| NCT04655586 (8) [back to overview] | Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b) |
| NCT04655586 (8) [back to overview] | Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b) |
| NCT04655586 (8) [back to overview] | Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b) |
| NCT04655586 (8) [back to overview] | Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b) |
| NCT04655586 (8) [back to overview] | Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b) |
| NCT04655586 (8) [back to overview] | Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b) |
| NCT04842292 (3) [back to overview] | Mean PaO2/FiO2 Ratio |
| NCT04842292 (3) [back to overview] | Incidence of Venous Thromboembolism |
| NCT04842292 (3) [back to overview] | Clinically Significant Bleeding |
Number of Patients With Recurrence of Venous Thromboembolism
(NCT00277394)
Timeframe: prior to day 90 +/- 5
| Intervention | Patients (Number) |
|---|
| Innohep® | 16 |
| Heparin | 9 |
Number of Patients With Major Bleeding Events
(NCT00277394)
Timeframe: prior to day 90 +/- 5
| Intervention | Patients (Number) |
|---|
| Innohep® | 12 |
| Heparin | 10 |
Number of Patients With Clinically Relevant Bleeding Events
(NCT00277394)
Timeframe: prior to day 90 +/- 5
| Intervention | Patients (Number) |
|---|
| Innohep® | 32 |
| Heparin | 32 |
The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.
Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery. (NCT00329433)
Timeframe: 30 days after surgery
| Intervention | participants (Number) |
|---|
| Desirudin | 6 |
| Heparin | 8 |
The Incidence of Bleeding in Each Group.
(NCT00329433)
Timeframe: Up to 30 days after surgery
| Intervention | Participants (Count of Participants) |
|---|
| Desirudin | 2 |
| Heparin | 2 |
The Incidence of DVTs in Each Group.
(NCT00329433)
Timeframe: 7 days after surgery
| Intervention | Participants (Count of Participants) |
|---|
| Desirudin | 3 |
| Heparin | 2 |
Pharmacology Arm - Major Adverse Ischemic Cardiac Events and Major Bleeding Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) and major bleeding (bleeding adjudicated as not related to coronary artery bypass grafting). (NCT00433966)
Timeframe: 30 Days
| Intervention | Participants (Count of Participants) |
|---|
| Pharmacology Arm - Bivalirudin | 166 |
| Pharmacology Arm - Unfractionated Heparin | 218 |
Stent Arm - Death, Reinfarction, Stroke, or Stent Thrombosis
Number of Participants With Death, Reinfarction, Stroke, or Stent Thrombosis (NCT00433966)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Stent Arm - Paclitaxel-Eluting Stent | 181 |
| Stent Arm - Bare Metal Stent | 59 |
Stent Arm - Ischemic Target Lesion Revascularization
Number of Participants With Ischemic Target Lesion Revascularization (NCT00433966)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Stent Arm - Paclitaxel-Eluting Stent | 98 |
| Stent Arm - Bare Metal Stent | 54 |
Stent Arm - Segment Binary Angiographic Restenosis
Number of Participants With Segment Binary Angiographic Restenosis (13-month Angiographic Subset). (NCT00433966)
Timeframe: 13 months
| Intervention | Participants (Count of Participants) |
|---|
| Stent Arm - Paclitaxel-Eluting Stent | 102 |
| Stent Arm - Bare Metal Stent | 76 |
Pharmacology Arm - Major Adverse Cardiovascular Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) (NCT00433966)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Pharmacology Arm - Bivalirudin | 379 |
| Pharmacology Arm - Unfractionated Heparin | 377 |
Pharmacology Arm - Major Adverse Cardiovascular Events
Number of participants with major adverse cardiovascular events (death, reinfarction, target-vessel revascularization for ischemia, and stroke) (NCT00433966)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Pharmacology Arm - Bivalirudin | 98 |
| Pharmacology Arm - Unfractionated Heparin | 99 |
Number of Subjects With Death or Non-fatal Myocardial Infarction (MI), Computed Separately, at End of Hospitalization and 30 Days
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) at end of hospitalization and on Day 30. Death: fatal event resulting from any cause. New MI: defined by electrocardiographic and/or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. (NCT00435487)
Timeframe: End of hospitalization, Day 30
| Intervention | participants (Number) |
|---|
| Arm A: Dalteparin | 3 |
| Arm B: Unfractioned Heparin (UFH) | 3 |
Number of Subjects With Bleeding by Thrombolysis in Myocardial Infarction (TIMI) Criteria
Thrombolysis in myocardial infarction (TIMI) major bleeding: at least a 5-grams per deciliter (g/dL) decrease in hemoglobin, at least a 15 percent (%) decrease in hematocrit, or intracranial bleeding. TIMI minor bleeding: associated with gastrointestinal or genitourinary bleeding, with an absolute decrease in hemoglobin of 4 g/dL or more, or decrease in hematocrit of at least 12%. (NCT00435487)
Timeframe: End of hospitalization, Day 30
| Intervention | participants (Number) |
|---|
| Arm A: Dalteparin | 0 |
| Arm B: Unfractioned Heparin (UFH) | 0 |
Number of Subjects With Stent Thrombosis and Abrupt Closures During Hospitalization
Abrupt vessel closure and or stent thrombosis: occurrence of vessel closure (no visible antegrade flow of contrast dye occurring after balloon angioplasty) or stent thrombosis determined angiographically. (NCT00435487)
Timeframe: End of hospitalization, Day 30
| Intervention | participants (Number) |
|---|
| Arm A: Dalteparin | 0 |
| Arm B: Unfractioned Heparin (UFH) | 0 |
Number of Subjects With Death or Non-fatal Myocardial Infarction Through and Up to Day 30
Death or non-fatal myocardial infarction (MI) after receiving 48 hours of study medication (event date - first dose date) on or before day 30 from baseline. Death: fatal event resulting from any cause. New MI: electrocardiographic (ECG) and or biomarker criteria of myocardial necrosis. Biochemical markers: creatine phosphokinase - myocardial band (CPK-MB) levels and the qualitative troponin-T test. (NCT00435487)
Timeframe: Baseline to Day 30
| Intervention | participants (Number) |
|---|
| Death | Non-fatal Myocardial Infarction | Death or Non-fatal Myocardial Infarction |
|---|
| Arm A: Dalteparin | 2 | 2 | 4 |
,| Arm B: Unfractioned Heparin (UFH) | 4 | 1 | 5 |
Number of Subjects With Stroke
Stroke: a sudden, focal neurologic deficit that is not reversible within 24 hours and is not the result of any readily identifiable cause (e.g., tumor or trauma). (NCT00435487)
Timeframe: End of hospitalization, Day 30
| Intervention | participants (Number) |
|---|
| Arm A: Dalteparin | 1 |
| Arm B: Unfractioned Heparin (UFH) | 0 |
Number of Subjects With Recurrent Angina With or Without Need for Hospitalization and or Revascularization
Recurrent angina: angina at rest lasting at least five minutes that was associated with a new ST-segment shift (elevation or depression) of more than 0.1 millivolt (mV), or with T-wave inversions, in two contiguous electrocardiographic leads; angina without electrocardiographic changes that prompted a decision to perform a revascularization procedure; or angina after hospital discharge that resulted in rehospitalization. (NCT00435487)
Timeframe: End of hospitalization, Day 30
| Intervention | participants (Number) |
|---|
| Arm A: Dalteparin | 3 |
| Arm B: Unfractioned Heparin (UFH) | 3 |
Hospital Death During the Index Hospitalization
(NCT00445211)
Timeframe: 0-4 post surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intra-Aortic Balloon Pump With Heparin | 0 |
| Intra-Aortic Balloon Pump Without Heparin | 0 |
Major Bleeding During the Index Hospitalization
Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death. (NCT00445211)
Timeframe: 0-4 days post surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intra-Aortic Balloon Pump With Heparin | 0 |
| Intra-Aortic Balloon Pump Without Heparin | 0 |
Major Ischemia (Decreased Blood Flow) During the Index Hospitalization
Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis. (NCT00445211)
Timeframe: 0-4 days post surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intra-Aortic Balloon Pump With Heparin | 0 |
| Intra-Aortic Balloon Pump Without Heparin | 0 |
Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization
Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function (NCT00445211)
Timeframe: 0-4 days post surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intra-Aortic Balloon Pump With Heparin | 0 |
| Intra-Aortic Balloon Pump Without Heparin | 0 |
Confirmed Thromboembolic Events
Confirmed thromboembolic events = 'present' if any following events are present/abnormal, otherwise = 'absent': Deep vein thrombosis measured by Color Doppler ultrasonography lower limbs; pulmonary embolism by chest xray, ventilation-perfusion scan, computed tomography pulmonary angiography; Sudden Death within 24 hours of venous thromboembolism symptoms. (NCT00445328)
Timeframe: Day 21
| Intervention | participants (Number) |
|---|
| Present | Absent |
|---|
| Dalteparin | 0 | 37 |
,| Unfractionated Heparin | 0 | 35 |
Composite of Objectively Verified Thromboembolic Events
Subjects with objectively verified thromboembolic events: symptomatic proximal and distal deep vein thrombosis [DVT], asymptomatic proximal DVT, fatal or symptomatic non-fatal pulmonary embolism [PE] or sudden death within 24 hours of onset of venous thromboembolism (VTE) symptoms. Occurrence of any ='Present', otherwise = 'Absent'. (NCT00445328)
Timeframe: Day 21
| Intervention | participants (Number) |
|---|
| Symptomatic DVT Present | Symptomatic DVT Absent | Symptomatic Proximal DVT Present | Symptomatic Proximal DVT Absent | Symptomatic Distal DVT Present | Symptomatic Distal DVT Absent | Asymptomatic Proximal DVT Present | Asymptomatic Proximal DVT Absent | Fatal pulmonary embolism Present | Fatal pulmonary embolism Absent | Symptomatic non-fatal pulmonary embolism Present | Symptomatic non-fatal pulmonary embolism Absent | Sudden Death within 24 hours of VTE Present | Sudden Death within 24 hours of VTE Absent |
|---|
| Dalteparin | 0 | 37 | 0 | 37 | 0 | 37 | 0 | 37 | 0 | 37 | 0 | 37 | 0 | 37 |
,| Unfractionated Heparin | 0 | 35 | 0 | 35 | 0 | 35 | 0 | 35 | 0 | 35 | 0 | 35 | 0 | 35 |
Bleeding - Major or Minor
Subjects with bleeding. Bleeding classified as major if it is: intraocular, spinal/epidural, intracranial or retroperitoneal; or if hemoglobin decreased by ≥ 2 g/dl(grams/deciliter); or if transfusion of ≥ 2 Units of blood or if significant medical or surgical intervention was required; or if it results in death. All other bleeding is classified as minor. (NCT00445328)
Timeframe: Day 21
| Intervention | participants (Number) |
|---|
| Major Bleeding | Minor Bleeding |
|---|
| Dalteparin | 0 | 0 |
,| Unfractionated Heparin | 1 | 0 |
Thrombocytopenia
Subjects with thrombocytopenia (low platelets). (NCT00445328)
Timeframe: Day 21
| Intervention | participants (Number) |
|---|
| Dalteparin | 35 |
| Unfractionated Heparin | 31 |
Stroke - Ischemic or Hemorrhagic
Subjects with stroke (either ischemic or hemorrhagic) based on results of CT (computed tomographic) pulmonary angiography (NCT00445328)
Timeframe: Day 21
| Intervention | participants (Number) |
|---|
| Dalteparin | 0 |
| Unfractionated Heparin | 0 |
All Cause Mortality
Subjects with death from any cause: end of study. (NCT00445328)
Timeframe: Day 14, Day 21 (End of Study)
| Intervention | participants (Number) |
|---|
| Dalteparin | 0 |
| Unfractionated Heparin | 1 |
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after PCI
| Intervention | participants (Number) |
|---|
| Heparin | 0 |
| Bivalirudin | 1 |
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after Fondaparinux administration, prior to randomization
| Intervention | participants (Number) |
|---|
| Heparin | 0 |
| Bivalirudin | 0 |
The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after randomization, during PCI
| Intervention | participants (Number) |
|---|
| Heparin | 0 |
| Bivalirudin | 0 |
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
(NCT00508924)
Timeframe: 5 - 10 min after initial bolus
| Intervention | second (Median) |
|---|
| ARG250 | 301.0 |
| ARG300 | 330.0 |
| ARG350 | 354.0 |
| Heparin | 237.5 |
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
"Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30~Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay" (NCT00508924)
Timeframe: 30 Days
| Intervention | participants (Number) |
|---|
| Composite end point (a) | Composite end point (b) | All cause death | Myocardial infarction | Urgent revascularization | Major bleeding |
|---|
| ARG250 | 1 | 1 | 0 | 0 | 1 | 0 |
,| ARG300 | 0 | 0 | 0 | 0 | 0 | 0 |
,| ARG350 | 1 | 1 | 0 | 1 | 1 | 0 |
,| Heparin | 1 | 2 | 0 | 1 | 0 | 1 |
Primary Assisted Patency
Primary assisted patency is defined as patency in the target lesion maintained by repeat intervention (one or more follow-up procedures) in an attempt to salvage the stent prior to complete occlusion (blockage) of the treated arterial segment, and also includes patients with primary patency. (NCT00541307)
Timeframe: 12 months
| Intervention | percentage of subjects (Number) |
|---|
| Gore Viabahn Endoprosthesis | 85.6 |
Primary Patency at 12 Months
Primary patency is defined as no evidence of restenosis (repeat narrowing) or occlusion (total blockage) within the originally treated lesion based on color-coded duplex sonography (color Doppler ultrasound (CDUS). The Peak Systolic Velocity Ratio must be less than 2.5 (PSVR: the result of taking the highest rate of blood flow within the stented region and dividing it by the highest rate of blood flow just above the stented area). (NCT00541307)
Timeframe: 12 months
| Intervention | percentage of subjects (Number) |
|---|
| Gore Viabahn Endoprosthesis | 72.9 |
Secondary Patency
Secondary patency is defined as patency in the target lesion maintained by repeat intervention (one more more follow-up procedures) after complete occlusion (blockage) of the treated arterial segment, and also includes patients that have primary and primary assisted patency. (NCT00541307)
Timeframe: 12 months
| Intervention | percentage of subjects (Number) |
|---|
| Gore Viabahn Endoprosthesis | 92.2 |
Clinical Events Defined as the Composite of 30-day Death, MI, Repeat Revascularization, Catheter Thrombus, Stroke, Thrombocytopenia, Bailout Use of Glycoprotein IIb/IIIa Inhibitors and Bleeding.
(NCT00543400)
Timeframe: 30 days
| Intervention | patients experiencing an event (Number) |
|---|
| 70 U/kg of Unfractionated Heparin Given IV | 47 |
| 50 IU/kg of M118 | 10 |
| 75 IU/KG of M118 | 43 |
| 100 IU/kg of M118 | 47 |
Rate of Catheter Clotting Measured as Requirement for tPA Usage to Maintain Blood Flow
The rate of thrombolytic agent use required to maintain blood flow adequate for dialysis was used as an objective measure of clinically significant catheter clotting. (NCT00571259)
Timeframe: 5 years
| Intervention | tPA use/1,000 catheter-days (Number) |
|---|
| 1: Heparin Lock | 3.42 |
| 2: Gentamicin Lock | 2.36 |
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 15 weeks
| Intervention | RBC Transfusions (Mean) |
|---|
| Usual Care | 2.3 |
| Exercise | 1.8 |
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Platelet transfusions (Mean) |
|---|
| Usual Care | 3.1 |
| Exercise | 2.3 |
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 15 weeks
| Intervention | g/dl (Mean) |
|---|
| Baseline | Before transplantation | During transplantation | At discharge |
|---|
| Exercise | 11.6 | 11.0 | 10.4 | 10.6 |
,| Usual Care | 12.1 | 10.8 | 10.1 | 10.6 |
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. (NCT00577096)
Timeframe: up to 30 weeks
| Intervention | g/dl (Mean) |
|---|
| Baseline | Before Transplantation | During Transplanation | At Discharge |
|---|
| Exercise | 11.7 | 12.0 | 10.8 | 11.0 |
,| Usual Care | 11.5 | 12.0 | 10.8 | 10.9 |
Total Number of Days of Stem Cell Collection (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Days (Mean) |
|---|
| Usual Care | 5.3 |
| Exercise | 4.0 |
Total Number of Days of Stem Cell Collection (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Days (Mean) |
|---|
| Usual Care | 4.9 |
| Exercise | 4.5 |
Number of Stem Cell Collection Attempts (Short Term)
(NCT00577096)
Timeframe: up to 15 weeks
| Intervention | Stem Cell Collection Attempts (Mean) |
|---|
| Usual Care | 1.4 |
| Exercise | 1.1 |
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank. (NCT00577096)
Timeframe: up to 30 weeks
| Intervention | RBC Transfusions (Mean) |
|---|
| Usual Care | 1.8 |
| Exercise | 1.0 |
Number of Stem Cell Collection Attempts (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Stem Cell Collection Attempts (Mean) |
|---|
| Usual Care | 1.3 |
| Exercise | 1.1 |
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
(NCT00577096)
Timeframe: up to 30 weeks
| Intervention | Platelet Transfusions (Mean) |
|---|
| Usual Care | 3.6 |
| Exercise | 2.0 |
Recurrence of Central Venous Line Infection Within 35 Days of Enrollment
(NCT00680459)
Timeframe: 35 days
| Intervention | # of pts with recurrent infection (Number) |
|---|
| 70% Ethanol Solution | 3 |
| Heparin Flush | 1 |
Preservation of Central Venous Line (Line Not Requiring Removal) by Day 35 of Study
(NCT00680459)
Timeframe: 35 days
| Intervention | number of lines preserved (Number) |
|---|
| 70% Ethanol Solution | 6 |
| Heparin Flush | 6 |
Clearance of Central Venous Line Infection by Day 6 of Study
(NCT00680459)
Timeframe: 6 days
| Intervention | number of CVL cleared (Number) |
|---|
| 70% Ethanol Solution | 7 |
| Heparin Flush | 6 |
Thromboembolic Events
(NCT00721136)
Timeframe: 30 days
| Intervention | participants (Number) |
|---|
| Moderate Risk Continuing Warfarin (Coumadin) | 0 |
| Moderate Risk Holding Warfarin (Coumadin) | 1 |
| High Risk Continuing Warfarin (Coumadin) | 0 |
| High Risk Holding Warfarin (Coumadin) | 0 |
Bleeding Complication
Significant bleeding was defined as extracardiac bleeding or pocket hematomas that required additional intervention and/or temporary discontinuation of anticoagulation therapy. (NCT00721136)
Timeframe: 30 days
| Intervention | participants (Number) |
|---|
| Moderate Risk Continuing Warfarin | 0 |
| Moderate Risk Holding Warfarin | 2 |
| High Risk Continuing Warfarin | 0 |
| High Risk Holding Warfarin | 2 |
Need for Antibiotics
(NCT00779558)
Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Intervention | participants (Number) |
|---|
| Study Drug | 14 |
| Placebo | 9 |
Thrombosis
Echocardiographic evidence of thrombosis while on study drug (NCT00779558)
Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
| Intervention | participants (Number) |
|---|
| Study Drug | 8 |
| Placebo | 6 |
Total PRBCs Transfused
(NCT00779558)
Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Intervention | mL/kg (Mean) |
|---|
| Study Drug | 8.8 |
| Placebo | 5.6 |
Days to Extubation
(NCT00779558)
Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Intervention | days (Mean) |
|---|
| Study Drug | 3.5 |
| Placebo | 3.3 |
Cardiac ICU Length of Stay
(NCT00779558)
Timeframe: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
| Intervention | days (Mean) |
|---|
| Study Drug | 10 |
| Placebo | 6.9 |
Progression-free Survival
Progression-free survival is the time from registration to disease progression or death. Patients alive without disease progression were censored at the time of the last disease assessment. (NCT00790842)
Timeframe: 56 months
| Intervention | Months (Median) |
|---|
| Group A=30-60 CrCl (mL/Min) | 12.6 |
| Group B=CrCL<30 mL/Min Not on Dialysis | 11.4 |
| Group C=CrCL<30 mL/Min and on Dialysis | NA |
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, <5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): >=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or to < 200 mg per 24 hours, >=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, >=50% reduction in bone marrow plasma cells, if baseline percentage was >=30%, >=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components (NCT00790842)
Timeframe: 56 months
| Intervention | percentage of participants (Number) |
|---|
| Group A CrCl 30-60 mL/Min | 60.0 |
| Group B CrCL<30 mL/Min, Not on Dialysis | 60.0 |
| Group C CrCL<30 mL/Min and on Dialysis | 20.0 |
Overall Survival Time
Overall survival is the time from registration to death from any cause. Patients alive at the time of analysis were censored at the date last known alive. (NCT00790842)
Timeframe: 56 months
| Intervention | months (Median) |
|---|
| Group A=30-60 CrCl (mL/Min) | 20.8 |
| Group B=CrCL<30 mL/Min Not on Dialysis | 20.0 |
| Group C=CrCL<30 mL/Min and on Dialysis | NA |
Number of Participants in Phase I Component With Dose Limiting Toxicities During the First Cycle of Therapy
"Dose Limiting Toxicity (DLT) was defined as any of the following events determined by the investigator to be possibly, probably, or definitely related to lenalidomide within the first cycle of therapy irrespective of whether the adverse events resolved:~Grade 3 or higher neutropenia with fever ≥38.5 degrees C~Grade 4 neutropenia ≥7 days~Grade 4 or higher thrombocytopenia~Other non-hematologic Grade 4 or higher adverse event not present prior to starting therapy or not due to underlying cause" (NCT00790842)
Timeframe: First cycle of therapy (28 days)
| Intervention | Participants (Count of Participants) |
|---|
| Group A Lenalidomide 10 mg/Day | 0 |
| Group A Lenalidomide 15 mg/Day | 0 |
| Group A Lenalidomide 25 mg/Day | 0 |
| Group B Lenalidomide 15 mg/2 Days | 0 |
| Group B Lenalidomide 25 mg/2 Days | 0 |
| Group B Lenalidomide 15 mg/Day | 0 |
| Group B Lenalidomide 25 mg/Day | 0 |
| Group C Lenalidomide 15 mg 3x/Week | 0 |
| Group C Lenalidomide 10 mg/Day | 0 |
| Group C Lenalidomide 15 mg/Day | 0 |
| Group C Lenalidomide 25 mg/Day | 0 |
Duration of Response
Duration of response was defined as time between the onset of response and disease progression in months, among patients treated at the recommended phase II dose who experienced a response to treatment. Per criteria of the International Myeloma Working Group, progressive disease was defined as one of the following: increase of 25% from best confirmed response in serum M-component, urine M-component, free light chain (FLC), bone marrow plasma cell percentage, or development of new or increase in size of bone lesions or soft tissue plasma cytomas. Development of hypercalcemia that can be attributed solely to the myeloma also constituted progression. (NCT00790842)
Timeframe: 56 months
| Intervention | Months (Median) |
|---|
| Group A=30-60 CrCl (mL/Min) | 21.8 |
| Group B=CrCL<30 mL/Min Not on Dialysis | 8.4 |
| Group C=CrCL<30 mL/Min and on Dialysis | 25.4 |
Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR
| Intervention | participants (Number) |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 59 |
| OL Fondaparinux Background + Standard Dose UFH During PCI | 39 |
Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
| Intervention | participants (Number) |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 48 |
| OL Fondaparinux Background + Standard Dose UFH During PCI | 58 |
Number of Participants With Major Bleeding During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
| Intervention | participants (Number) |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 14 |
| OL Fondaparinux Background + Standard Dose UFH During PCI | 12 |
Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
| Intervention | participants (Number) |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 33 |
| OL Fondaparinux Background + Standard Dose UFH During PCI | 43 |
Number of Participants With Minor Bleeding During the Peri-PCI Period
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)
| Intervention | participants (Number) |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 7 |
| OL Fondaparinux Background + Standard Dose UFH During PCI | 17 |
Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30
| Intervention | participants (Number) |
|---|
| Death during peri-PCI period | MI during peri-PCI period | TVR during peri-PCI period | Definite/Probable Stent Thrombosis during peri-PCI | Stroke during peri-PCI | Death at Day 30 | MI at Day 30 | TVR at Day 30 | Definite/Probable Stent Thrombosis at Day 30 | Stroke at Day 30 |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 1 | 20 | 3 | 1 | 3 | 8 | 31 | 9 | 12 | 5 |
,| OL Fondaparinux Background + Standard Dose UFH During PCI | 2 | 16 | 2 | 2 | 5 | 6 | 25 | 3 | 5 | 5 |
Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30
The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30
| Intervention | participants (Number) |
|---|
| Composite of death, MI, and TVR Peri-PCI | Composite of death, MI, and TVR at Day 30 |
|---|
| OL Fondaparinux Background + Low Dose UFH During PCI | 23 | 46 |
,| OL Fondaparinux Background + Standard Dose UFH During PCI | 19 | 29 |
Number of Participants With Bleeding Events
Bleeding is categorized using the TIMI criteria as major or minor bleeding. The time window for inclusion of bleeding events was up until 3 days post-procedure or discharge (whichever occurred first). (NCT00818753)
Timeframe: First administration until 7-14 days after PCI (Percutaneous Coronary Intervention)
| Intervention | participants (Number) |
|---|
| Dabigatran 110mg Bis in Die (BID) | 0 |
| Dabigatran 150mg Bis in Die (BID) | 0 |
| Heparin | 1 |
Percentage of Participants Who Experienced Abrupt Vessel Closure, New Thrombus With Reduced Reflow or no Reflow
Investigator reported outcome (NCT00818753)
Timeframe: From 22 to 165 minutes
| Intervention | Percentage of participants (Number) |
|---|
| Dabigatran 110mg Bis in Die (BID) | 10.5 |
| Dabigatran 150mg Bis in Die (BID) | 4.8 |
| Heparin | 0 |
Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00911157)
Timeframe: From Day 1 to Day 90 (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| Fondaparinux Sodium (FPX) | 0 |
| Unfractionated Heparin (UFH) | 0 |
Percentage of Participants With a Bleeding Event
Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). (NCT00911157)
Timeframe: Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).
| Intervention | percentage of participants (Number) |
|---|
| Major bleeding | Minor bleeding only | Any bleeding (major and/or minor bleedings) |
|---|
| Fondaparinux Sodium (FPX) | 3.4 | 3.4 | 6.9 |
,| Unfractionated Heparin (UFH) | 0 | 0 | 0 |
Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline
"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE." (NCT00911157)
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
| Intervention | percentage of participants (Number) |
|---|
| Improved | No Change | Worse |
|---|
| Fondaparinux Sodium (FPX) | 18.5 | 81.5 | 0 |
,| Unfractionated Heparin (UFH) | 11.1 | 88.9 | 0 |
Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)
VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE. (NCT00911157)
Timeframe: From Day 1 to Day 90 (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| Symptomatic DVT only | (Symptomatic) Non-fatal PE | (Symptomatic) Fatal PE | Asymptomatic DVT only | Asymptomatic PE |
|---|
| Fondaparinux Sodium (FPX) | 0 | 0 | 0 | 3.6 | 0 |
,| Unfractionated Heparin (UFH) | 0 | 0 | 0 | 0 | 0 |
Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10
Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). (NCT00911157)
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)
| Intervention | points on a scale (Mean) |
|---|
| Baseline | Change from Baseline |
|---|
| Fondaparinux Sodium (FPX) | 0.944 | 0.015 |
,| Unfractionated Heparin (UFH) | 0.959 | 0.004 |
Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Thrombus-negative par. until 4 days after EOT | Thrombus-positive par. until 4 days after EOT | Thrombus-negative participants until the FU | Thrombus-positive participants until the FU |
|---|
| Fondaparinux | 0 | 0 | 1 | 0 |
,| UFH/VKA | 1 | 0 | 1 | 0 |
Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days
Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants
| Intervention | participants (Number) |
|---|
| Fondaparinux | 3 |
| UFH/VKA | 2 |
Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed. (NCT00911300)
Timeframe: Day 1 until Day 3
| Intervention | participants (Number) |
|---|
| Fondaparinux | 137 |
| UFH/VKA | 133 |
Number of Participants Who Were Re-hospitalized
Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| until 4 days after EOT | until the FU |
|---|
| Fondaparinux | 14 | 18 |
,| UFH/VKA | 7 | 11 |
Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Clot-negative par. until 4 days after EOT | Clot-positive par. until 4 days after EOT | Clot-negative participants until the FU | Clot-positive participants until the FU |
|---|
| Fondaparinux | 109 | 5 | 105 | 4 |
,| UFH/VKA | 115 | 4 | 106 | 5 |
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Thrombus-negative par. until 4 days after EOT | Thrombus-positive par. until 4 days after EOT | Thrombus-negative participants until the FU | Thrombus-positive participants until the FU |
|---|
| Fondaparinux | 0 | 0 | 0 | 0 |
,| UFH/VKA | 0 | 0 | 0 | 0 |
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Thrombus-negative par. until 4 days after EOT | Thrombus-positive par. until 4 days after EOT | Thrombus-negative participants until the FU | Thrombus-positive participants until the FU |
|---|
| Fondaparinux | 3 | 0 | 3 | 1 |
,| UFH/VKA | 4 | 0 | 5 | 0 |
Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Thrombus-negative par. until 4 days after EOT | Thrombus-positive par. until 4 days after EOT | Thrombus-negative participants until the FU | Thrombus-positive participants until the FU |
|---|
| Fondaparinux | 3 | 0 | 4 | 0 |
,| UFH/VKA | 1 | 0 | 1 | 0 |
Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)
| Intervention | participants (Number) |
|---|
| Thrombus-negative par. until 4 days after EOT | Thrombus-positive par. until 4 days after EOT | Thrombus-negative participants until the FU | Thrombus-positive participants until the FU |
|---|
| Fondaparinux | 1 | 0 | 3 | 0 |
,| UFH/VKA | 0 | 0 | 0 | 0 |
Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE
Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF. (NCT00911300)
Timeframe: At second TEE (at Day 28+/-4)
| Intervention | participants (Number) |
|---|
| Fondaparinux | 3 |
| UFH/VKA | 7 |
Safety, Side Effects
collection of adverse events and safety information. Each participant was contacted either at a clinical visit or by phone every two weeks while enrolled in the study. (NCT00948441)
Timeframe: 7 months per study patient
| Intervention | participants (Number) |
|---|
| Ethanol Lock | 11 |
| Heparin Lock | 11 |
The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse
"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE." (NCT00981409)
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)
| Intervention | percentage of participants (Number) |
|---|
| Improved | No change | Worse |
|---|
| Fondaparinux Sodium (FPX) | 78.6 | 21.4 | 0 |
,| Unfractionated Heparin (UFH) | 90.0 | 10.0 | 0 |
The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)
VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00981409)
Timeframe: From Day 1 to Day 90 (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| Symptomatic DVT only | (Symptomatic) Non-fatal PE | (Symptomatic) Fatal PE | Asymptomatic DVT only | Asymptomatic PE |
|---|
| Fondaparinux Sodium (FPX) | 0 | 0 | 0 | 0 | 0 |
,| Unfractionated Heparin (UFH) | 0 | 0 | 0 | 0 | 0 |
Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10
The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). (NCT00981409)
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)
| Intervention | points on a scale (Mean) |
|---|
| Baseline | Change from baseline, Days 5-10 (+/-1) |
|---|
| Fondaparinux Sodium (FPX) | 0.654 | 0.101 |
,| Unfractionated Heparin (UFH) | 0.586 | 0.185 |
The Percentage of Participants With a Bleeding Event
Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). (NCT00981409)
Timeframe: FPX or UFH treatment period (Days 5-10, on average)
| Intervention | percentage of participants (Number) |
|---|
| Major bleeding only | Minor bleeding | Any bleeding (major and/or minor bleeding) |
|---|
| Fondaparinux Sodium (FPX) | 0 | 9.7 | 9.7 |
,| Unfractionated Heparin (UFH) | 0 | 0 | 0 |
The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00981409)
Timeframe: From Day 1 to Day 90 (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| Fondaparinux Sodium (FPX) | 0 |
| Unfractionated Heparin (UFH) | 0 |
Symptomatic Recurrent VTE, i.e., the Composite of DVT, Non-fatal PE, and Fatal PE
"Symptomatic recurrent Venous Thromboembolism (VTE), i.e., the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE occurring during the Overall Study Period.~Overall Study Period defined as The time from the reference date (randomization date/initial dose of study drug date) to the last study follow-up visit." (NCT00986154)
Timeframe: 12 months from time of randomization
| Intervention | number or participants with an event (Number) |
|---|
| Heparin/Edoxaban Tosylate | 130 |
| Heparin/Warfarin | 146 |
Clinically Relevant Bleeding (i.e., Major or Clinically Relevant Non-major Bleeding) Occurring During Treatment
Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment plus 3 days after their last dose for that time period. (NCT00986154)
Timeframe: 12 months from time of randomization
| Intervention | participants with an event (Number) |
|---|
| Heparin/Edoxaban Tosylate | 349 |
| Heparin/Warfarin | 423 |
The Composite Clinical Outcome of Symptomatic Recurrent VTE and All-cause Mortality
(NCT00986154)
Timeframe: 12 months from time of randomization
| Intervention | number of participants with event (Number) |
|---|
| Heparin/Edoxaban Tosylate | 228 |
| Heparin/Warfarin | 228 |
Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)
Live birth occurs when a fetus (> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord. (NCT01051778)
Timeframe: pregnancy > 24weeks gestation
| Intervention | Percentage of pregnancies (Number) |
|---|
| Enoxaparin 40 mg /Day Plus Low Dose Aspirin | 24 |
| Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin | 20 |
Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.
| Intervention | participants (Number) |
|---|
| Bleeding or hematoma as complication of a surgery | Epistaxis |
|---|
| Fondaparinux | 1 | 0 |
,| Low Molecular Weight Heparins (LMWHs) | 0 | 1 |
Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first
| Intervention | participants (Number) |
|---|
| Bleeding or hematoma as complication of a surgery | Epistaxis | Gastrointestinal bleeds | Hemarthrosis | Intracranial bleeds | Urinary tract bleeding |
|---|
| Fondaparinux | 7 | 0 | 0 | 0 | 0 | 1 |
,| Low Molecular Weight Heparins (LMWHs) | 10 | 3 | 9 | 2 | 1 | 1 |
The Incidence of Thrombocytopenia
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Thrombocytopenia was defined as a post-procedural platelet count <100,000 cells/millimeter cubed (cells/mm^3) in a participant with a baseline or pre-procedural platelet count >100,000 cells/mm^3. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 0.7 |
| Standard of Care: Heparins With Optional GPI | 1.4 |
The Incidence of Major Bleeding: Thrombolysis in MI (TIMI) and Global Utilization of Streptokinase and tPA for Occluded Coronary Arteries (GUSTO)
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Major bleeding based on TIMI criteria was defined as any intra-cranial bleeding, or any bleeding associated with clinically overt signs associated with a drop in Hb of >5 g/dL (or, when Hb was not available, an absolute drop in hematocrit [Hct] >15%). Major bleeding based on GUSTO criteria was defined as severe/life-threatening: intra-cranial hemorrhage or resulting in substantial hemodynamic compromise requiring treatment. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Major bleeding: TIMI | Major bleeding: GUSTO |
|---|
| Bivalirudin | 1.3 | 1.3 |
,| Standard of Care: Heparins With Optional GPI | 2.1 | 2.3 |
The Incidence of Minor Bleeding: TIMI and GUSTO
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Minor bleeding based on TIMI criteria was defined as any clinically overt sign of bleeding (including observation by imaging techniques) that was associated with a fall in Hb of ≥3 g/dL and ≤5 g/dL (or, when Hb was not available, an absolute drop in Hct of ≥9% and ≤15%). Minor bleeding based on GUSTO criteria was defined as other bleed not requiring blood transfusion or causing hemodynamic compromise. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Minor bleeding: TIMI | Minor bleeding: GUSTO |
|---|
| Bivalirudin | 6.5 | 6.5 |
,| Standard of Care: Heparins With Optional GPI | 11.2 | 11.0 |
The Incidence of Stroke
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stroke was defined as a sudden, focal neurological defect resulting from a cerebrovascular cause, resulting in death or lasting greater than 24 hours that was not due to a readily identifiable cause, such as a tumor, infection, or trauma. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 0.6 |
| Standard of Care: Heparins With Optional GPI | 1.0 |
The Incidence of Stent Thrombosis (Academic Research Consortium [ARC Definition])
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Stent thrombosis, based on the ARC definition, was defined as angiographic confirmation of stent thrombosis, non-occlusive thrombus, occlusive thrombus, or pathological confirmation of stent thrombosis. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 1.6 |
| Standard of Care: Heparins With Optional GPI | 0.5 |
The Composite Incidence of Death and Non-coronary Artery Bypass Graft (CABG) Major Bleeding
A participant was defined to have had a composite event if the participant experienced at least 1 of the 2 components (death or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any 1 of the following: intra-cranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in hemoglobin (Hb) concentration of >4 grams/deciliter (g/dL) without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding; re-intervention for bleeding, or use of any blood product transfusion. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 5.1 |
| Standard of Care: Heparins With Optional GPI | 8.5 |
The Composite Incidence of Death, Re-infarction (MI), or Non-CABG Major Bleeding
A participant had a composite event if the participant experienced at least 1 of the 3 components (death, re-infarction [MI], or non-CABG major bleeding) of the composite. Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. Non-CABG major bleeding was defined as any one of the following: intracranial, retroperitoneal, intraocular, access site hemorrhage requiring radiological or surgical intervention, reduction in Hb concentration of >4 g/dL without an overt source of bleeding, reduction in hemoglobin concentration of >3 g/dL with an overt source of bleeding, re-intervention for bleeding, use of any blood product transfusion. MI was defined as a positive diagnosis of re-infarction (new event) not associated with index PCI. (NCT01087723)
Timeframe: Within 30 days
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 6.6 |
| Standard of Care: Heparins With Optional GPI | 9.2 |
The Incidence of Death at 1 Year
Incidence=the number of participants to experience the event/total number of at risk participants x 100. Death was defined as death from any cause at any time. (NCT01087723)
Timeframe: Within 1 Year
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 5.4 |
| Standard of Care: Heparins With Optional GPI | 5.3 |
Subject Incidence of Proteinuria
"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result at the specified time point.~Incidence of proteinuria defined as urinary protein/creatinine ratio exceeding 200 mg/g was calculated at Day 4 and overall at any time point. Incidence was calculated by treatment as number of subjects with proteinuria divided by the total number of subjects." (NCT01163097)
Timeframe: Day 4
| Intervention | participants (Number) |
|---|
| Palifermin Alone | 0 |
| Untreated Control | 0 |
Ratio to Baseline of Protein/Creatinine
"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio." (NCT01163097)
Timeframe: Day 4
| Intervention | ratio (Geometric Mean) |
|---|
| Palifermin Alone | 0.076 |
| Untreated Control | 0.104 |
Ratio to Baseline of Protein/Creatinine
"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio." (NCT01163097)
Timeframe: Day 3
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.1 |
| Untreated Control | 1.1 |
Ratio to Baseline of Protein/Creatinine
"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio." (NCT01163097)
Timeframe: Day 2
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.0 |
| Untreated Control | 1.0 |
Ratio to Baseline of Protein/Creatinine
"Protein/creatinine ratio is the urinary protein (mg) divided by the urinary creatinine (g) result.~Ratio to baseline protein/creatinine ratio was calculated as protein/creatinine ratio at specified day divided by baseline protein/creatinine ratio." (NCT01163097)
Timeframe: Day 1
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.00 |
| Untreated Control | 1.00 |
Ratio to Baseline of Lipase.
Ratio to baseline lipase at Day 5 was calculated as Day 5 lipase divided by baseline lipase. (NCT01163097)
Timeframe: Day 5
| Intervention | ratio (Geometric Mean) |
|---|
| Palifermin - Heparin | -0.487 |
| Palifermin Alone | 0.499 |
Ratio to Baseline of Epithelial Cell Proliferation as Assessed by Ki67 Staining of Buccal Mucosal Tissue.
This outcome is a measure of the palifermin effect on the buccal mucosal cells. Ki67 is a measure of proliferation of cells in the buccal mucosa. This measure assess the number of cells per millimeter (mm) before and after palifermin treatment. (NCT01163097)
Timeframe: Day 4
| Intervention | ratio (Geometric Mean) |
|---|
| Palifermin - Heparin | 0.267 |
| Palifermin Alone | 0.414 |
Ratio to Baseline of Amylase
Ratio to baseline amylase at Day 5 was calculated as Day 5 amylase divided by baseline amylase. (NCT01163097)
Timeframe: Day 5
| Intervention | ratio (Geometric Mean) |
|---|
| Palifermin - Heparin | 0.242 |
| Palifermin Alone | 0.547 |
Palifermin Pharmacokinetic (PK) Parameters: Clearance (CL)
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 1
| Intervention | (mL/hr/kg) (Geometric Mean) |
|---|
| Palifermin - Heparin | 121.1 |
| Palifermin Alone | 527.8 |
Ratio to Baseline of Albumin/Creatinine
"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio." (NCT01163097)
Timeframe: Day 3
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.16 |
| Untreated Control | 0.99 |
Ratio to Baseline of Albumin/Creatinine
"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio." (NCT01163097)
Timeframe: Day 1
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.00 |
| Untreated Control | 1.00 |
Palifermin PK Parameters: Vss
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 3
| Intervention | mL/Kg (Geometric Mean) |
|---|
| Palifermin - Heparin | 361.7 |
| Palifermin Alone | 1318 |
Palifermin PK Parameters: Estimated Concentration at Time 0 (C0)
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 1
| Intervention | ng/mL (Geometric Mean) |
|---|
| Palifermin - Heparin | 229.1 |
| Palifermin Alone | 584.7 |
Palifermin PK Parameters: CL
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive PK parameters for palifermin CL for subjects assigned to Treatment A and Treatment B was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 3
| Intervention | (mL/hr/kg) (Geometric Mean) |
|---|
| Palifermin - Heparin | 121.9 |
| Palifermin Alone | 524.3 |
Palifermin PK Parameters: C0
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin C0 was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 3
| Intervention | ng/mL (Geometric Mean) |
|---|
| Palifermin - Heparin | 361.0 |
| Palifermin Alone | 563.2 |
Palifermin PK Parameters: AUC (0-24)
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation." (NCT01163097)
Timeframe: Day 3
| Intervention | ng*hr/mL (Geometric Mean) |
|---|
| Palifermin - Heparin | 328.1 |
| Palifermin Alone | 76.26 |
Palifermin PK Parameters: Area Under the Serum Curve (AUC) (0-24)
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin.~Descriptive pharmacokinetic parameters for palifermin AUC(0-24) was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was deleted from calculation." (NCT01163097)
Timeframe: Day 1
| Intervention | ng*hr/mL (Geometric Mean) |
|---|
| Palifermin - Heparin | 330.1 |
| Palifermin Alone | 75.80 |
Palifermin PK Parameters: Apparent Volume of Distribution at Steady State (Vss)
"Blood samples for palifermin PK was collected pre-dose on Days 1 and 3 of the treatment period; 2, 5, 15 and 30 minutes; and 1, 2, 4, 6, 12, 18 and 24 hours after the Day 1 and Day 3 dose of palifermin (Treatment A and Treatment B only).~Descriptive pharmacokinetic parameters for palifermin Vss was determined by linear/log trapezoidal method. Parameters was calculated from individual subject serum concentration-time data using actual subject blood collection times. Serum concentrations reported below the lower limit of quantification (LLOQ) was treated as zero." (NCT01163097)
Timeframe: Day 1
| Intervention | mL/kg (Geometric Mean) |
|---|
| Palifermin - Heparin | 411.5 |
| Palifermin Alone | 1586 |
Ratio to Baseline of Albumin/Creatinine
"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio." (NCT01163097)
Timeframe: Day 2
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.05 |
| Untreated Control | 0.95 |
Ratio to Baseline of Albumin/Creatinine
"The albumin/creatinine ratio is the urinary albumin (mg) divided by the urinary creatinine (g) result at the specified time point.~Ratio to baseline was calculated as albumin/creatinine ratio at specified day divided by baseline albumin/creatinine ratio." (NCT01163097)
Timeframe: Day 4
| Intervention | ratio (Mean) |
|---|
| Palifermin Alone | 1.56 |
| Untreated Control | 1.25 |
Subject Incidence of Treatment-emergent Adverse Event
Adverse events (AE) was considered treatment emergent if the AE started after the time of heparin titration (Treatment A), palifermin dosing on Day 1 (Treatment B), or set zero point (Treatment C). (NCT01163097)
Timeframe: Day 45
| Intervention | participants (Number) |
|---|
| Palifermin - Heparin | 9 |
| Palifermin Alone | 8 |
| Untreated Control | 3 |
Reduction of RV/LV Ratio
Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography. (NCT01166997)
Timeframe: 24 hours
| Intervention | Ratio (Mean) |
|---|
| Unfractionated Heparin (UFH) Alone | 0.03 |
| Unfractionated Heprin + EkoSonic Procedure | 0.30 |
Major Bleeding and Intracranial Bleeding at 30 Days.
Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy. (NCT01166997)
Timeframe: 30 days
| Intervention | participants (Number) |
|---|
| Ultrasound Accelerated Thrombolysis | 0 |
| Intravenous Unfractionated Heparin | 0 |
Filter Life
The primary endpoint for this study will be the difference in filter life in hours between the group receiving dilute heparin and the group receiving standard concentrated heparin. (NCT01318811)
Timeframe: 72 hours
| Intervention | hours (Mean) |
|---|
| Dilute Heparin | 22.46 |
| Standard Concentrated Heparin | 33 |
Number of Major Bleeding Complications
Information on major bleeding complications, and need for blood product transfusions will be collected. (NCT01318811)
Timeframe: 72 hours
| Intervention | clinical active major bleeding episodes (Number) |
|---|
| Dilute Heparin | 0 |
| Standard Concentrated Heparin | 0 |
VEINS-QOL
The VEINS-QOL is a questionnaire that represents a patient's quality of life, using measures like how well the patient can walk, sleep, and enjoy life. Responses are graded on a scale of 1-5, with 1 being very good, and 5 being very poor. The VEINS-QOL measure is defined by the count of participants that showed a decreased overall score following their procedure. (NCT01406795)
Timeframe: Up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 1 |
Stent Migration
Stent migration is reported as the count of participants with stent migration within 1 year following stent placement. (NCT01406795)
Timeframe: up to one year following the procedure 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Stent Migration
Stent migration is reported as the count of participants with stent migration within 1 month following stent placement. (NCT01406795)
Timeframe: up to 1 month following the procedure
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Secondary Patency
Secondary patency means that the initial intervention failed and a second intervention was performed to establish or maintain patency. Secondary patency is defined as the count of participants that required a second intervention to establish patency. (NCT01406795)
Timeframe: up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Primary Patency Rate
Patency refers to whether the stent is unoccluded (open). Primary patency rate was defined as the count of participants with >= 50% patency following initial stent placement, and is reported as the count of participants meeting this criteria. (NCT01406795)
Timeframe: up to 1 year following the procedure
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 1 |
Decrease in Swelling of Affected Extremity
The count of participants that experienced a decrease in swelling after the stent was placed. (NCT01406795)
Timeframe: up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Assisted-primary Patency
Patency refers to whether the stent is unoccluded (open). Primary refers to the first time a stent was placed (or the first time patency needed to be established). Assisted refers to the fact that a device (like a balloon) was used to open the stent. Assisted-primary patency is defined as the count of participants that demonstrated the need for an intervention to establish patency. (NCT01406795)
Timeframe: up to 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Adverse Events
Adverse events were reported as the count of participants that experienced an adverse event within two years of their procedure. (NCT01406795)
Timeframe: up to two years 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Venous Stent Arm | 0 |
Cumulative Incidence of Relapse in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Relapse was defined as new CLABSI with an identical organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with relapse is reported. (NCT01472965)
Timeframe: Up to 25 weeks after the start of treatment
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 6.3 |
| Control (Placebo) | 8.7 |
Adverse Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Adverse events attributable to lock therapy or related to the central venous access device (CVAD) were elicited from direct questioning at study visits and from the medical record. The percentage of evaluable participants with any potentially attributable adverse effect is reported. (NCT01472965)
Timeframe: Up to 37.5 weeks after the start of treatment.
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 60.4 |
| Control (Placebo) | 39.1 |
Cumulative Incidence of Reinfection in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Reinfection was defined as new CLABSI with a different organism occurring during the 24 week prophylaxis phase. The percentage of evaluable participants with reinfection is reported. (NCT01472965)
Timeframe: Up to 25 weeks after the start of treatment.
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 27.3 |
| Control (Placebo) | 24.4 |
Cumulative Incidence of Therapeutic Failure in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The cumulative incidence of therapeutic failure is reported. (NCT01472965)
Timeframe: Up to 25 weeks after the start of treatment
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 44.0 |
| Control (Placebo) | 43.9 |
Percentage of Therapeutic Failures (Early or Late Failure) in Children and Adolescents With CLABSI Receiving Standard Care Plus Ethanol Lock Therapy (ELT) vs. Standard Care Alone
Therapeutic failure was a pre-defined composite outcome comprising either 'early failure': central line removal, death, persistent positive blood cultures for >72 hours, development of new CLABSI, or initiation of other ALT) during the 5 day treatment phase, or 'late failure': relapse (new CLABSI with an identical organism), or reinfection (new CLABSI with a different organism) during the 24 week prophylaxis phase. The percentage of evaluable participants with therapeutic failure is reported. (NCT01472965)
Timeframe: Up to 25 weeks after the start of treatment.
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 43.8 |
| Control (Placebo) | 43.5 |
Rate of Central Venous Access Device (CVAD) Occlusion Events in Participants Receiving Standard Care Plus ELT vs. Standard Care Alone
Occlusion was defined as central line occlusion or dysfunction requiring thrombolytic therapy. The percentage of evaluable participants requiring thrombolytic therapy for central line occlusion is reported. (NCT01472965)
Timeframe: Up to 26 weeks after the start of treatment.
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ethanol) | 58.3 |
| Control (Placebo) | 32.6 |
Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization
(NCT01519518)
Timeframe: 28 days
| Intervention | percentage of total participants (Number) |
|---|
| Unfractionated Heparin | 5.7 |
| Bivalirudin | 8.7 |
Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition
(NCT01519518)
Timeframe: 28 days
| Intervention | percentage of total participants (Number) |
|---|
| Unfractionated Heparin | 10.8 |
| Bivalirudin | 9.2 |
Stent Thrombosis Rate (ARC Definite or Probable)
(NCT01519518)
Timeframe: 28 days
| Intervention | percentage of total participants (Number) |
|---|
| Unfractionated Heparin | 0.9 |
| Bivalirudin | 3.4 |
Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition
(NCT01519518)
Timeframe: 28 days
| Intervention | percentage of total participants (Number) |
|---|
| Unfractionated Heparin | 3.1 |
| Bivalirudin | 3.5 |
Change in Circulating Leptin Levels
The Leptin AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | ng*min/ml (Mean) |
|---|
| Placebo | 2050 |
| High Dose Fat Solution | 3639 |
| Low Dose Fat Solution | 5439 |
| Oral Fat | 4973 |
Change in Circulating Insulin Levels
The Insulin AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | mU*min/ml (Mean) |
|---|
| Placebo | 1765 |
| High Dose Fat Solution | 2072 |
| Low Dose Fat Solution | 2103 |
| Oral Fat | 3021 |
Change in Circulating Glucose Levels
The Glucose AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | mg*min/dl (Mean) |
|---|
| Placebo | 30683 |
| High Dose Fat Solution | 28735 |
| Low Dose Fat Solution | 32566 |
| Oral Fat | 31364 |
Change in Circulating Glucagon-like Peptide-1 (GLP-1) Levels
The GLP-1 area under the curve (AUC) was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | pM*min (Mean) |
|---|
| Placebo | 7147 |
| High Dose Fat Solution | 11725 |
| Low Dose Fat Solution | 11898 |
| Oral Fat | 28060 |
Change in Circulating Ghrelin Levels
The Ghrelin AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | pg*min/ml (Mean) |
|---|
| Placebo | 172886 |
| High Dose Fat Solution | 129451 |
| Low Dose Fat Solution | 207863 |
| Oral Fat | 166195 |
Change in Circulating Adiponectin Levels
The Adiponectin AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | ng*min/ml (Mean) |
|---|
| Placebo | 1546442 |
| High Dose Fat Solution | 2273306 |
| Low Dose Fat Solution | 1778846 |
| Oral Fat | 1970601 |
Change in Circulating Peptide Tyrosine Tyrosine (PYY) Levels
The PYY AUC was calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | pg*min/ml (Mean) |
|---|
| Placebo | 90016 |
| High Dose Fat Solution | 65131 |
| Low Dose Fat Solution | 82474 |
| Oral Fat | 144702 |
Change in Circulating Gastric Inhibitory Polypeptide (GIP) Levels
The GIP AUC fwas calculated from baseline to six hours (NCT01520454)
Timeframe: Baseline to 6 hours
| Intervention | pM*min/ml (Mean) |
|---|
| Placebo | 12894 |
| High Dose Fat Solution | 11830 |
| Low Dose Fat Solution | 19386 |
| Oral Fat | 60559 |
Primary Graft Patency Rate
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention. (NCT01601873)
Timeframe: 12 months
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 35 |
| Standard Graft | 33 |
Primary Graft Patency Rate
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention. (NCT01601873)
Timeframe: 24 months after graft placement
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 24 |
| Standard Graft | 25 |
Primary-Assisted Graft Patency Rate
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention. (NCT01601873)
Timeframe: 12 months
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 57 |
| Standard Graft | 60 |
Primary-Assisted Graft Patency Rate
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention. (NCT01601873)
Timeframe: 24 months after graft placement
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 26 |
| Standard Graft | 22 |
Secondary Graft Patency Rate
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm. (NCT01601873)
Timeframe: 12 months
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 62 |
| Standard Graft | 52 |
Secondary Graft Patency Rate
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm. (NCT01601873)
Timeframe: 24 months after graft placement
| Intervention | Percentage of participants (Number) |
|---|
| PROPATEN | 48 |
| Standard Graft | 38 |
Number of Participants With Complications or Morbidity Attributable to the Study
Complication/morbidity associated with both types of interventions (NCT01601873)
Timeframe: at least 1 year but up to two years
| Intervention | Participants (Count of Participants) |
|---|
| PROPATEN | 0 |
| Standard Graft | 0 |
Number of Postoperative Re-interventions
(NCT01601873)
Timeframe: at least 1 year but up to two years
| Intervention | post-operative re-interventions (Mean) |
|---|
| PROPATEN | 2.7 |
| Standard Graft | 2.0 |
Major Vascular Complications
The percentage of participants reporting a major vascular complications as defined by VARC is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| at 48 hours or before hospital discharge | at up to 30 days (±7 days) follow-up |
|---|
| Bivalirudin | 8.7 | 9.2 |
,| Unfractionated Heparin (UFH) | 9 | 9.5 |
New Onset Atrial Fibrillation/Flutter
The percentage of participants reporting new onset atrial fibrillation/flutter is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| at 48 hours or before hospital discharge | at up to 30 days (±7 days) follow-up |
|---|
| Bivalirudin | 3.2 | 5.4 |
,| Unfractionated Heparin (UFH) | 2.5 | 4 |
Timing Effect on Bleeding Event Rate up to 48 Hours or Hospital Discharge
The effect of timing on bleeding event rates (the percentage of participants with an incidence of major bleeding) is presented. (NCT01651780)
Timeframe: Up to 48 hours after procedure or at hospital discharge (but also includes any subsequent hospitalizations)
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin: First Half of Study Site's Enrolled Participants | 6.4 |
| Bivalirudin: Second Half of Study Site's Enrolled Participants | 6.4 |
| UFH: First Half of Study Site's Enrolled Participants | 11.6 |
| UFH: Second Half of Study Site's Enrolled Participants | 8.5 |
Acute Kidney Injury
The percentage of participants reporting acute kidney injury is presented. (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
| Intervention | percentage of participants (Number) |
|---|
| at 48 hours or before hospital discharge | at up to 30 days (±7 days) follow-up |
|---|
| Bivalirudin | 10.9 | 18.8 |
,| Unfractionated Heparin (UFH) | 6.5 | 13.8 |
Bleeding BARC 3a, BARC Types 1 or 2, and TIMI Minor
The percentage of participants with moderate bleeding as defined by BARC 3a and minor bleeding as defined as BARC type 1 and 2 and TIMI minor is presented. (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
| Intervention | percentage of participants (Number) |
|---|
| BARC 3a at 48 hours or hospital discharge | BARC types 1 and 2 at 48 hours or discharge | TIMI minor at 48 hours or hospital discharge | BARC 3a at 30 days | BARC types 1 and 2 at 30 days | TIMI minor at 30 days |
|---|
| Bivalirudin | 15.6 | 20.8 | 16.6 | 18.8 | 27.7 | 21.3 |
,| Unfractionated Heparin (UFH) | 13.3 | 21.1 | 14.3 | 17.3 | 25.6 | 19.3 |
Major Adverse Cardiac Events (MACE) Including Death, Non-fatal MI, and Stroke
The percentage of participants reporting a MACE overall and the individual components of MACE (including death, non-fatal MI, and stroke) are presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| MACE at 48 hours or before hospital discharge | Death at 48 hours or before hospital discharge | MI at 48 hours or before hospital discharge | Stroke at 48 hours or before hospital discharge | MACE at up to 30 days | Death at up to 30 days | MI at up to 30 days | Stroke at up to 30 days |
|---|
| Bivalirudin | 3.5 | 1.5 | 0 | 2 | 7.7 | 4.7 | 0.5 | 3.5 |
,| Unfractionated Heparin (UFH) | 4.8 | 1.8 | 1.3 | 2 | 8 | 4.8 | 1.8 | 2.8 |
Major Bleeding According to Additional Scales (VARC, TIMI, GUSTO, ACUITY/HORIZONS)
"Percentage of participants with major bleeding according to the following scales:~Valve Academic Research Consortium (VARC)=life threatening, disabling bleeding, or major bleeding~Thrombolysis in Myocardial Infarction (TIMI)=major bleeding~Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO)=severe or moderate~Acute Catheterization and Urgent Intervention Triage StrategY (ACUITY)/Harmonizing Outcomes with RevasculariZatiON and Stents (HORIZONS)=major bleeding" (NCT01651780)
Timeframe: at 48 hours or hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days) follow-up
| Intervention | percentage of participants (Number) |
|---|
| VARC at 48 hours or before hospital | TIMI at 48 hours or before hospital | GUSTO at 48 hours or hospital discharge | ACUITY/HORIZONS at 48 hours or hospital discharge | VARC at 30 days | TIMI at 30 days | GUSTO at 30 days | ACUITY/HORIZONS at 30 days |
|---|
| Bivalirudin | 21.8 | 4 | 13.9 | 26 | 26.5 | 5.7 | 16.3 | 33.4 |
,| Unfractionated Heparin (UFH) | 19.6 | 6.5 | 11.6 | 24.4 | 24.6 | 7.3 | 14.6 | 29.6 |
Transient Ischemic Attack
The percentage of participants reporting transient ischemic attack is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| at 48 hours or before hospital discharge | at up to 30 days (±7 days) follow-up |
|---|
| Bivalirudin | 0 | 0 |
,| Unfractionated Heparin (UFH) | 0 | 0 |
NACE at 48 Hours or Before Hospital Discharge
NACE at 48 hours or before hospital discharge is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, MI, and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 8.9 |
| Unfractionated Heparin (UFH) | 12.6 |
Major Bleeding (BARC ≥3b) at 48 Hours or Before Hospital Discharge
"Major bleeding (Bleeding Academic Research Consortium [BARC] type ≥3b) was defined as follows:~Bleeds that were evident clinically, or by laboratory or imaging results, which resulted in surgical intervention or administration of IV vasoactive drugs; overt bleeds with a hemoglobin drop of at least 5 grams per deciliter (g/dL); and bleeding that caused cardiac tamponade.~BARC 3c includes intracranial or intraocular bleeds that compromised vision.~BARC type 4 (Coronary Artery Bypass Grafting [CABG]-related bleeding) includes perioperative intracranial bleeding within 48 hours, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 units of whole blood or packed red blood cells within a 48 hour period; and chest tube output ≥2 liters (L) within a 24-hour period.~BARC type 5, fatal bleeding, describes bleeds that directly result in death with no other cause." (NCT01651780)
Timeframe: at 48 hours or discharge, whichever occurs first
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 6.9 |
| Unfractionated Heparin (UFH) | 9 |
Net Adverse Clinical Events (NACE) at up to 30 Days
The net adverse cardiac events (NACE) at 30 days is the composite of major adverse cardiovascular events (MACE) + major bleeding (BARC type ≥3b). The composite of MACE is defined as all-cause mortality, myocardial infarction (MI), and stroke. A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint. (NCT01651780)
Timeframe: up to 30 days after procedure
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 14.4 |
| Unfractionated Heparin (UFH) | 16.1 |
Acquired Thrombocytopenia
The percentage of participants reporting acquired thrombocytopenia is presented. (NCT01651780)
Timeframe: at 48 hours or before hospital discharge, whichever occurred earlier, and at up to 30 days (±7 days)
| Intervention | percentage of participants (Number) |
|---|
| at 48 hours or before hospital discharge | at up to 30 days (±7 days) |
|---|
| Bivalirudin | 16.6 | 24 |
,| Unfractionated Heparin (UFH) | 17.3 | 23.1 |
Number of Participants With Major Adverse Cardiovascular Events (MACE)
MACE is defined as a composite of non-fatal myocardial infarction (MI), non-fatal stroke, non-fatal systemic embolic event (SEE) and cardiovascular death (NCT01662908)
Timeframe: Initial dose of study drug up to 3 days after last dose
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 2 |
| Warfarin | 0 |
Number of Participants With Clinically Relevant Bleeding
Clinically relevant bleeding was defined as major or clinically relevant non-major bleeding (NCT01662908)
Timeframe: Initial dose of study drug up to 3 days after last dose
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 3 |
| Warfarin | 2 |
Number of Participants With Change From Baseline in the Presence or Absence of Thrombus by Vessel
(NCT01662908)
Timeframe: Baseline to final visit (Day 14-21)
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 0 |
| Warfarin | 0 |
Relative Change From Baseline in Thrombus Volume Assessed by MRI [Using the Magnetic Resonance Venography (MRV) Method]
Thrombus Volume (mm^3) was measured at baseline and between days 14 to 21 using MRI results as determined by Magnetic Resonance Venography (MRV) method, and the relative percentage change from baseline was calculated (NCT01662908)
Timeframe: Baseline to final visit (Day 14-21)
| Intervention | percentage of change (Mean) |
|---|
| Edoxaban | -46.6 |
| Warfarin | -51.4 |
Number of Participants With Recurrence of Venous Thromboembolism (VTE)
Number of participants with investigator-confirmed recurrent VTE events that start or worsen after the first dose of study drug and prior to the date of the final visit or telephone contact (inclusive) (NCT01662908)
Timeframe: Baseline to final visit (Day 14-21)
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 4 |
| Warfarin | 2 |
Pulmonary Embolus
Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain. (NCT01729559)
Timeframe: Within 30 days from admission to hospital
| Intervention | participants (Number) |
|---|
| 5000 Units Unfractionated Heparin Q 8 Hours | 1 |
| 30mg Enoxaparin Q12 Hours | 0 |
Lower Extremity Deep Vein Thrombosis
Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group. (NCT01729559)
Timeframe: Within 30 days of hospital admission
| Intervention | percentage of patients (Number) |
|---|
| 5000 Units Unfractionated Heparin Q 8 Hours | 4.8 |
| 30mg Enoxaparin Q12 Hours | 2.9 |
Heparin Induced Thrombocytopenia
The possible occurrence of heparin induced thrombocytopenia (HIT) was investigated when any patient (in either low molecular weight heparin [LMWH] or low dose unfractionated heparin [LDUH] study arm) had a platelet count drop of ≥50% (from a baseline value at the time of initiation of VTE prophylaxis) between day 5 and 14 following initiation of chemoprophylaxis per American College of Chest Physicians (ACCP) guidelines. (NCT01729559)
Timeframe: Within 30 of admission to hospital
| Intervention | participants (Number) |
|---|
| 5000 Units Unfractionated Heparin Q 8 Hours | 1 |
| 30mg Enoxaparin Q12 Hours | 0 |
Bleeding Event
Bleeding events will be classified by the Graafsma et al. severity of bleeding criteria (Major, Minor or No Bleeding). A major bleeding event will be defined as any overt bleeding following initiation of chemoprophylaxis associated with one or more of the following; a decrease in hemoglobin of ≥2 g/dL, bleeding leading to a transfusion of ≥2 units of packed red blood cells, a new retroperitoneal or intracranial bleed, or bleeding that warranted cessation of chemoprophylaxis treatment. Minor bleeding is defined as clinically evident bleeding not meeting criteria for major bleeding. (NCT01729559)
Timeframe: Within 30 days of admission to hospital
| Intervention | participants (Number) |
|---|
| 5000 Units Unfractionated Heparin Q 8 Hours | 2 |
| 30mg Enoxaparin Q12 Hours | 3 |
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
Computed tomography pulmonary angiography (CTPA) was used to assess thrombotic burden in the participants with PE and the results were classified as improved, no change, or worsened. The timings of CTPA examinations were Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| CTPA - Week 2 (n=18, n=17) | CTPA - Week 12 (n=18, n=16) | CTPA - Week 24 (n=16, n=15) |
|---|
| Apixaban | 0 | 0 | 0 |
,| Unfractionated Heparin (UFH)/Warfarin | 0 | 0 | 1 |
Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
Computed tomography venography (CTV) and compression ultrasound (CUS) were used to assess thrombotic burden in the participants with DVT and the results were classified as improved, no change, or worsened. The timings of CTV and CUS examinations were at Week 12 and Weeks 2, 12 and 24. (NCT01780987)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| CUS - Week 2 (n=22, n=22) | CTV - Week 12 (n=20, n=21) | CUS - Week 12 (n=21, n=22) | CUS - Week 24 (n=20, n=22) |
|---|
| Apixaban | 1 | 0 | 0 | 0 |
,| Unfractionated Heparin (UFH)/Warfarin | 2 | 0 | 0 | 1 |
Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. (NCT01780987)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| Apixaban | 3 |
| Unfractionated Heparin (UFH)/Warfarin | 11 |
Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. (NCT01780987)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| Apixaban | 0 |
| Unfractionated Heparin (UFH)/Warfarin | 2 |
Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
All bleeding events consisted of major bleeding (per Interactional Society on Thrombosis and Homeostasis ［ISTH］ Definition), clinically relevant non-major (CRNM) and minor bleeding. All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRMN bleeding were classified as minor bleeding. (NCT01780987)
Timeframe: Baseline to Week 24
| Intervention | participants (Number) |
|---|
| Apixaban | 7 |
| Unfractionated Heparin (UFH)/Warfarin | 17 |
Participants With Myocardial Infarction (MI), Stroke/Transient Ischemic Attack (TIA), Unplanned Repeat Revascularization (URV), Death, and Minor Bleeding Up to 48 h Post Study Drug Administration
"Outcome assessments at 48 h post study drug initiation include bleeding events defined as BARC Type 2 or greater (BARC ≥2), bleeding events defined as thrombolysis in myocardial infarction (TIMI) major and TIMI minor, and net adverse clinical events (NACE) as adjudicated by the CEC (NACE=death, MI, stroke/TIA, amputations, URV, or bleeding events defined as BARC ≥3).~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation." (NCT01913483)
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
| Intervention | participants (Number) |
|---|
| Bleed (BARC ≥ Type 2) | TIMI major | TIMI minor | Death | MI | Stroke/TIA | Amputation | URV | NACE |
|---|
| Bivalirudin | 47 | 0 | 4 | 0 | 0 | 0 | 0 | 2 | 7 |
,| Unfractionated Heparin | 42 | 4 | 1 | 1 | 0 | 0 | 0 | 2 | 6 |
Participants With MI, Stroke/TIA, URV, Death, or Minor Bleeding Up to Day 30
"Outcome assessments at Day 30 include NACE, Major Adverse Clinical Events (MACE=death, MI, stroke/TIA, amputation, or URV), and bleeding defined as BARC ≥2, as adjudicated by the CEC.~In addition to Type 3(a-c), 4, and 5, BARC ≥2 also includes Type 2 bleeding, which is any overt, actionable sign of hemorrhage (more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for Type 3, 4, or 5, but does meet at least one of the following criteria of: requiring nonsurgical, medical intervention by a health-care professional; leading to hospitalization or increased level of care; prompting evaluation." (NCT01913483)
Timeframe: Study drug initiation (Day 1) up to 30 days
| Intervention | participants (Number) |
|---|
| Bleed (BARC ≥ Type 2) | Bleed (BARC ≥ Type 3) | Death | MI | Stroke/TIA | Amputation | URV | MACE (Death/MI/Stroke/Amputation/URV) | NACE |
|---|
| Bivalirudin | 53 | 6 | 2 | 0 | 1 | 8 | 9 | 18 | 22 |
,| Unfractionated Heparin | 51 | 7 | 3 | 1 | 2 | 5 | 11 | 19 | 23 |
Participants With Bleeding Academic Research Consortium Type 3 or Greater (BARC ≥3) Events Up to 48 h or at Hospital Discharge, As Adjudicated by the Independent Clinical Events Committee (CEC)
"BARC ≥3 includes:~Type 3a-3c: clinical, laboratory, and/or imaging evidence of bleeding, which includes any transfusion with overt bleeding, bleeds that result in surgical intervention or administration of IV vasoactive drugs, overt bleeds with a hemoglobin drop greater than or equal to 3 grams (g)/deciliters (dL) to greater than or equal to 5 g/dL, cardiac tamponade caused by bleeding, intracranial hemorrhage, and intraocular bleeds that compromise vision.~Type 4: (Coronary Artery Bypass Grafting-related Bleeding) includes perioperative intracranial bleeding within 48 h, bleeds that result in reoperation following closure of sternotomy for the purpose of controlling bleeding, bleeds that result in treatment with transfusion of ≥5 U of whole blood or packed red blood cells within a 48-h period; and chest tube output ≥2 liters within a 24-h period.~Type 5: fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death." (NCT01913483)
Timeframe: Study drug administration (Day 1) up to 48 h post study drug initiation or at hospital discharge, whichever occurs first
| Intervention | percentage of participants (Number) |
|---|
| Bivalirudin | 1.5 |
| Unfractionated Heparin | 1.6 |
Number of Participants With Bleeding Complications
"Major bleeding defined as any intracranial or intraocular hemorrhage or bleeding from any site associated with >2g/dL drop in hemoglobin or transfusion of >2 unit packed RBCs (including operative site bleeding, unexpected upper or lower gastrointestinal hemorrhage, or retroperitoneal hemorrhage) or any hemorrhage needing surgical intervention/reoperation or leading to death.~Minor bleeding defined as wound hematoma, ecchymosis >10 cm, epistaxis of more than 2 minute duration, macroscopic hematuria, unexpected upper or lower GI hemorrhage associated with <2g/dL drop in hemoglobin or <2 unit packed RBC transfusion" (NCT01976988)
Timeframe: 30 day postop period
| Intervention | participants (Number) |
|---|
| Post-op Heparin | 58 |
| Pre-op Heparin | 47 |
Number of Participants With Postoperative VTE Within 48 Hours After Surgery
Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period (NCT01976988)
Timeframe: 48 hour postop period
| Intervention | participants (Number) |
|---|
| Post-op Heparin | 5 |
| Pre-op Heparin | 3 |
Hospital Stay
Length of postoperative hospital stay (NCT01976988)
Timeframe: 30 day postop period
| Intervention | days (Median) |
|---|
| Post-op Heparin | 5 |
| Pre-op Heparin | 4.5 |
Number of Participants With Surgical Complications
Major or minor medical and surgical complications (NCT01976988)
Timeframe: 30 day postop period
| Intervention | participants (Number) |
|---|
| Post-op Heparin | 76 |
| Pre-op Heparin | 72 |
Number of Participants With VTE Within 30-day After Surgery
any VTE occuring within 30-days after surgery - clinical or asymptomatic - detected by venous duplex ultrasound, vq scan or ct pulmonary angiogram. (NCT01976988)
Timeframe: 30 day postop period
| Intervention | participants (Number) |
|---|
| Post-op Heparin | 7 |
| Pre-op Heparin | 3 |
Number of Participants With Postoperative Thrombocytopenia
Thrombocytopenia defined as >50% or greater drop in platelet count (NCT01976988)
Timeframe: 30 day postop period
| Intervention | participants (Number) |
|---|
| Post-op Heparin | 0 |
| Pre-op Heparin | 5 |
PTS Assessment Completion
Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year
| Intervention | Participants (Count of Participants) |
|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | 17 |
Number of Participants With Post-thrombotic Syndrome
The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
| Intervention | Participants (Count of Participants) |
|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | 0 |
Biomarker Sample Collection
Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | 7 |
Number of Participants With Major Bleeding
Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
| Intervention | Participants (Count of Participants) |
|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | 1 |
Number of Participants With Recurrent Thrombosis
Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal
| Intervention | Participants (Count of Participants) |
|---|
| Low-molecular-weight Heparin or Direct Oral Anticoagulant | 0 |
Number of Subjects Who Achieved a Morphologic Complete Remission
"A secondary endpoint of this study was to determine whether there was preliminary evidence of an effect of dociparstat on remission rate following cytarabine and idarubicin induction in acute myeloid leukemia (AML) patients, which included complete remission (CR) rate (with neutrophil and platelet count recovery) after the first induction cycle.~Morphologic CR was defined as absolute neutrophil count (ANC) >1000/μL, platelet count >100,000/μL, <5% bone marrow blasts, no Auer rods, and no evidence of extramedullary disease." (NCT02056782)
Timeframe: Day 1 to Day 35 (35 days)
| Intervention | Participants (Count of Participants) |
|---|
| Dociparstat | 11 |
Time (Days) to Transfusion-independent Platelet Recovery (Platelet Counts Values ≥ 20,000/μL and ≥ 50,000/μL Without a Platelet Transfusion)
A primary endpoint of this study was evidence of an effect of dociparstat on transfusion independent platelet recovery time. The time (days) to transfusion-independent platelet recovery will be defined as the number of days from the first day of chemotherapy until the first of 5 consecutive days with platelet counts values ≥ 20,000/μL and ≥ 50,000/μL without a platelet transfusion. (NCT02056782)
Timeframe: Day 1 to Day 35 (35 days)
| Intervention | days (Mean) |
|---|
| Platelet count of ≥20,000/µL | Platelet count of ≥50,000/µL |
|---|
| Dociparstat | 21.3 | 23.1 |
Number of Participants With Adjudicated Major Bleeding Events While on Treatment
The primary safety endpoint was major bleeding events during the On-Treatment Study Period (defined as on-study drug or up to 3 days after the last dose of study drug). (NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 32 |
| Dalteparin Group | 16 |
Number of Participants With Recurrent VTE, Major Bleed or All-Cause Death
(NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 235 |
| Dalteparin Group | 228 |
Number of Participants With Recurrent Venous Thromboembolism (VTE) During the Overall Study Period
(NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 41 |
| Dalteparin Group | 59 |
Number of Participants With Recurrent Non-Fatal Pulmonary Embolism (PE) During the Overall Study Period
(NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 21 |
| Dalteparin Group | 24 |
Number of Participants With Recurrent Deep Vein Thrombosis (DVT) During the Overall Study Period
(NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 19 |
| Dalteparin Group | 35 |
Number of Participants With Adjudicated Recurrent Venous Thromboembolism (VTE) or Major Bleeding Event
(NCT02073682)
Timeframe: 12 months
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban Group | 67 |
| Dalteparin Group | 71 |
Opioid Administration Per Participant
Total dose of opioids per participant (NCT02098993)
Timeframe: 7 days
| Intervention | mg (Mean) |
|---|
| Unfractionated Heparin | 3,446.75 |
| Standard of Care | 1,166.67 |
Duration of Fever Assessed by Body Temperature
Body temperature greater than or equal to 38.0 degrees Celsius (NCT02098993)
Timeframe: 7 days
| Intervention | hours (Mean) |
|---|
| Unfractionated Heparin | 24.90 |
| Standard of Care | 0 |
Time to Hospital Discharge
Duration of hospitalization (NCT02098993)
Timeframe: Until hospital discharge
| Intervention | hours (Mean) |
|---|
| Unfractionated Heparin | 279.43 |
| Standard of Care | 127.31 |
Units of Red Blood Cells Administered
Total number of units of red blood cells (NCT02098993)
Timeframe: 7 days
| Intervention | units (Number) |
|---|
| Unfractionated Heparin | 5 |
| Standard of Care | 4 |
Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain
Score of 4 or greater on the Visual Analog Scale for pain (NCT02098993)
Timeframe: 7 days
| Intervention | hours (Mean) |
|---|
| Unfractionated Heparin | 88.68 |
| Standard of Care | 117.52 |
Duration of Hypoxemia Assessed by Arterial Oxygen Saturation
Arterial oxygen saturation less than 90% (NCT02098993)
Timeframe: 7 days
| Intervention | hours (Mean) |
|---|
| Unfractionated Heparin | 117.62 |
| Standard of Care | 51.49 |
Percentage of Participants Requiring Mechanical Ventilation
(NCT02098993)
Timeframe: 7 days
| Intervention | percent of participants (Number) |
|---|
| Unfractionated Heparin | 0 |
| Standard of Care | 0 |
Percentage of Participants Transferred to Intensive Care Unit
(NCT02098993)
Timeframe: 7 days
| Intervention | percent of participants (Number) |
|---|
| Unfractionated Heparin | 0 |
| Standard of Care | 33 |
Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome
Acute development of 2 or more organs or organ systems unable to maintain homeostasis in a critically ill individual (NCT02098993)
Timeframe: 7 days
| Intervention | percent of participants (Number) |
|---|
| Unfractionated Heparin | 0 |
| Standard of Care | 0 |
Duration of Leukocytosis Assessed by White Blood Cell Count
White blood cell count greater than 10,000 per liter (NCT02098993)
Timeframe: 7 days
| Intervention | hours (Mean) |
|---|
| Unfractionated Heparin | 117.52 |
| Standard of Care | 53.11 |
Number of Participants With Different Type of Cardioversion Events
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using different type of cardioversion events i.e. electrical and pharmacologic. Electrical cardioversion was a procedure in which an electric current was used to reset the heart's rhythm back to its regular pattern (normal sinus rhythm). Pharmacologic cardioversion, also called chemical cardioversion, used antiarrhythmia medication instead of an electrical shock. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | participants (Number) |
|---|
| Electrical | Pharmacologic |
|---|
| Apixaban | 461 | 35 |
,| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 464 | 30 |
Duration of Hospital Stay of Participants
Duration of hospital stay was defined as the number of hours from hospital admission to hospital discharge followed by early cardioversion. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | hours (Median) |
|---|
| Apixaban | 45.36 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 49.47 |
Number of Participants Who Used Image Guidance Approach
An image-guided approach helped cardioversion earlier than the conventional minimum of 3 weeks of anticoagulation that would normally be required prior to cardioversion. Transesophageal echocardiography (TEE or TOE) and computed tomography (CT) were 2 image-guided approaches that were used in this study. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | participants (Number) |
|---|
| Apixaban | 383 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 399 |
Number of Participants With Acute Stroke Event
An acute stroke was defined as a new, important neurological insufficiency of rapid onset that lasted for at least 24 hours and that was not due to a readily identifiable non-vascular cause (like brain tumor or trauma). (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
| Intervention | participants (Number) |
|---|
| Apixaban | 0 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 |
Number of Participants With All Cause Death
(NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
| Intervention | participants (Number) |
|---|
| Apixaban | 2 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 1 |
Number of Participants With Clinically Relevant Non-Major Bleeding Events
Clinically relevant non-major bleeding was defined as the clinically evident bleeding that consisted of any bleeding that compromised hemodynamics, that led to hospitalization, subcutaneous hematoma larger than 25/100 centimeter square if there was a traumatic cause, intramuscular hematoma documented by ultrasonography, epistaxis, gingival bleeding occurred spontaneously, hematuria that was macroscopic and was spontaneous, macroscopic gastrointestinal hemorrhage included at least one episode of melena or hematemesis, rectal blood loss, hemoptysis or any other bleeding type considered to have clinical consequences for a participant, such as medical intervention, the need for unscheduled contact with a physician, or temporary cessation of a study drug, or associated with pain or impairment of activities of daily life. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
| Intervention | participants (Number) |
|---|
| Apixaban | 11 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 13 |
Number of Participants With Major Bleeding Event
Major bleeding was defined as clinically evident bleeding that was accompanied by one or more of the following: a decrease in hemoglobin of 2 gram per deciliter or more, a transfusion of 2 or more units of packed red blood cells, bleeding that was fatal or bleeding that occurred in at least one of the following critical sites: intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed was not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
| Intervention | participants (Number) |
|---|
| Apixaban | 3 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 6 |
Number of Participants With Systemic Embolism Event
Systemic embolism occurred in participant when there was a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), which was supported by evidence of embolism from surgical specimens, autopsy, angiography, or other objective testing. (NCT02100228)
Timeframe: Baseline up to 30 days post cardioversion (or up to 90 days after randomization, if cardioversion was not performed within that time frame)
| Intervention | participants (Number) |
|---|
| Apixaban | 0 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 0 |
Time to First Attempt of Cardioversion
Cardioversion was an effective method of converting an abnormally fast heart rate (tachycardia) or other cardiac arrhythmia to normal rhythm using electricity or drugs. First attempt of cardioversion was defined as the first time the participant was admitted for the cardioversion procedure. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | days (Median) |
|---|
| Apixaban | 2.0 |
| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 2.0 |
Number of Cardioversion Attempt of Participants
Cardioversion attempts were defined as the number of times the participant was admitted to hospital for the cardioversion procedure and not the number of attempts during a single hospital admission. (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | participants (Number) |
|---|
| No Cardioversion Attempt | 1 Cardioversion Attempt | More than 2 Cardioversion Attempts |
|---|
| Apixaban | 234 | 488 | 31 |
,| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 224 | 496 | 27 |
Number of Participants With Their Rhythm Status
Rhythm status was further distinguished into sinus rhythm, atrial fibrillation and atrial flutter. Sinus rhythm was defined as a normal heartbeat. Atrial fibrillation was an irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications and atrial flutter was a common abnormal heart rhythm that was usually associated with a fast heart rate (100 or more heart beats per minute). (NCT02100228)
Timeframe: Baseline up to Day of first attempt of cardioversion procedure (Visit 2, up to 130 days)
| Intervention | participants (Number) |
|---|
| Normal Sinus | Atrial Fibrillation | Atrial Flutter |
|---|
| Apixaban | 1 | 715 | 3 |
,| Parenteral Heparin/Oral Vitamin K Antagonist (Usual Care) | 2 | 704 | 6 |
Change in Oxidative Stress: Baseline to 4 Hours
Measure F-2 isoprostanes as a marker of oxidation (NCT02365285)
Timeframe: Baseline to 4 hours
| Intervention | pg/ml (Mean) |
|---|
| Galantamine 16 mg (African-American) | 0 |
| Galantamine 16 mg(White) | -0.008 |
| Placebo (African-American) | 0.003 |
| Placebo(White) | -0.008 |
Change in Oxidative Stress: Baseline to 2 Hours
Measure F-2 isoprostanes as a marker of oxidation (NCT02365285)
Timeframe: Baseline to 2 hours
| Intervention | pg /ml (Mean) |
|---|
| Galantamine 16 mg (African-American) | -0.003 |
| Galantamine 16 mg (White) | -0.006 |
| Placebo (African-American) | 0.01 |
| Placebo (White) | -0.006 |
CMR Assessment Of LVEF At Day 90
Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 90 are presented. (NCT02565147)
Timeframe: 90 days post PPCI
| Intervention | Percentage of Blood (Mean) |
|---|
| PPCI With Bivalirudin | 54.6 |
| PPCI With Heparin | 49.1 |
TIMI Flow And Myocardial Blush Grade (MBG) At End Of PPCI
"TIMI flow (grade 0-3) is an angiographic determination of briskness of epicardial coronary blood flow: TIMI 0 flow (no perfusion); TIMI 1 flow (penetration without perfusion); TIMI 2 flow (partial reperfusion); TIMI 3 flow (complete perfusion/normal flow).~MBG (grade 0-3) is an angiographic method for determination of blood flow in the distal myocardial vascular bed. Blush grades: 0 = failure of dye to enter the micro-vasculature; 1 = dye slowly enters but fails to exit the micro-vasculature; 2 = delayed entry and exit of dye from the micro-vasculature; 3 = normal entry and exit of dye from the micro-vasculature. Blush that is only mildly intense throughout the washout phase, but fades minimally, is also classified as grade 3.~The number of participants and their mean reported TIMI flow and MBG grades at the end of PPCI are presented." (NCT02565147)
Timeframe: 1 day (end of PPCI)
| Intervention | Units on a Scale (Mean) |
|---|
| TIMI Flow Grade | MBG |
|---|
| PPCI With Bivalirudin | 2.8 | 1.8 |
,| PPCI With Heparin | 2.8 | 1.5 |
CMR Assessment Of Myocardial Salvage Index (MSI) At Day 5
MSI is a CMR-derived parameter of myocardial recovery and treatment efficacy that allows comparisons among infarcts of different sizes. MSI is calculated as the difference between the area at risk (AAR) and the final infarct size, divided by the AAR, and it is expressed as a percentage of AAR. An MSI of 100% indicates maximum treatment success, whereas an MSI of 0% indicates no treatment benefit. The number of participants and their mean-reported MSI at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI
| Intervention | Percentage of AAR (Mean) |
|---|
| PPCI With Bivalirudin | 39.4 |
| PPCI With Heparin | 51.2 |
Percentage of Participants With In-Hospital Net Adverse Cardiac Events (NACE) At Day 5
"The NACE at 5 days is the composite of major bleeding (Bleeding Academic Research Consortium Type 3 or greater [BARC type ≥3]), death, re-infarction, and ischaemia driven revascularization (IDR).~In brief, BARC ≥3 includes: Type 3a-3c, clinical, laboratory, and/or imaging evidence of bleeding; Type 4, coronary artery bypass grafting-related bleeding; Type 5, fatal bleeding that directly results in death that is either clinically suspicious or is confirmed as the cause of death.~A participant was defined to have a composite event if the participant experienced at least 1 of the components. If the participant did not have any of the components, then he or she did not have the composite endpoint. If a participant had more than 1 of the components, he or she was only counted once in the determination of the total number of participants experiencing the composite endpoint.~The percentage of participants with in-hospital NACE up to Day 5 is presented." (NCT02565147)
Timeframe: 5 days post PPCI or at discharge, whichever occurs first
| Intervention | Percentage of Participants (Number) |
|---|
| PPCI With Bivalirudin | 7.1 |
| PPCI With Heparin | 8.3 |
CMR Assessment Of Left Ventricular Ejection Fraction (LVEF) At Day 5
Percentage of cardiac LVEF as assessed by CMR. LVEF is a measurement of the percentage of blood ejected out of the left ventricle with each contraction. The number of participants and their mean reported LVEF, as a percentage of blood, at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI
| Intervention | Percentage of Blood (Mean) |
|---|
| PPCI With Bivalirudin | 48.5 |
| PPCI With Heparin | 48.6 |
CMR Assessment Of Infarct Size At Day 5
Size of cardiac infarct, expressed as grams, as assessed by CMR. The use of CMR has dramatically improved the ability for accurate infarct size estimations and is therefore currently considered the gold standard. The number of participants and their mean reported infarct size, as grams, at Day 5 are presented. (NCT02565147)
Timeframe: 5 days post PPCI
| Intervention | Grams (Mean) |
|---|
| PPCI With Bivalirudin | 25.0 |
| PPCI With Heparin | 27.1 |
CMR Assessment Of Micro-vascular Obstruction (MVO) At Day 5
"Early and late assessment of MVO, expressed as grams, as assessed by CMR. MVO is an established complication of coronary reperfusion therapy for acute myocardial infarction. MVO occurs in the setting of reperfusion following prolonged myocardial ischemia and provides incremental prognostic information beyond infarct size, to which it is related. Early MVO is a prolonged (approximately 60 s) perfusion deficit in dynamic gadolinium (Gd) first-pass images that is determined within 2 minutes (min) of administration of the Gd-based contrast agent. Late MVO is usually assessed as a hypointense infarct core on late-Gd-enhancement images acquired 10 min after contrast administration.~The number of participants and their mean reported early and late MVO, as grams, at Day 5 are presented." (NCT02565147)
Timeframe: 5 days post PPCI
| Intervention | Grams (Mean) |
|---|
| CMR Early MVO Assessment | CMR Late MVO Assessment |
|---|
| PPCI With Bivalirudin | 5.3 | 3.7 |
,| PPCI With Heparin | 7.7 | 4.2 |
Index Of Microcirculatory Resistance (IMR)
"IMR, a predictor of clinical outcome, is a readily available, quantitative, and reproducible method for invasively assessing coronary microvascular function. It is measured using the thermodilution technique and defined as mean distal coronary pressure, expressed in millimeters (mm) of mercury (Hg), multiplied by the mean hyperemic transit time (s) (mmHg*s). Higher IMR values indicate poorer microcirculation and are associated with a worse clinical outcome. A cutoff point of 32 (associated with better clinical outcomes) was selected as the threshold. Only participants at study locations with previous experience in IMR measurements participated in this sub study.~The number of participants and their mean reported IMR at the end of PPCI are presented." (NCT02565147)
Timeframe: 1 day (end of PPCI)
| Intervention | mmHg*s (Mean) |
|---|
| PPCI With Bivalirudin | 43.49 |
| PPCI With Heparin | 68.66 |
Death At Day 90
Participant survival during the clinical follow-up period is presented as the number of participants with reported death at 90 days post PPCI. (NCT02565147)
Timeframe: 90 days post PPCI
| Intervention | Participants (Number) |
|---|
| PPCI With Bivalirudin | 0 |
| PPCI With Heparin | 1 |
Participants With a Study Catheter Removal for Any Reason
Analysis of all catheter removals during the study or until the catheter was removed (NCT02651428)
Timeframe: The event time was the number of days from randomization until catheter removal for any reason or until the subject was censored. The mean participant duration of exposure to study drug was 174 days (range 4-884 days).
| Intervention | Participants (Count of Participants) |
|---|
| Neutrolin Arm | 236 |
| Heparin Arm | 225 |
Change in LH Pulse Amplitude Before and After Acute or Chronic FFA Administration
LH-Luteinizing Hormone Pulse Amplitude before and after administration of FFAs. This is a measure of the post supplementation frequent blood sampling session and the baseline session. (NCT02653092)
Timeframe: First 4 hours of the frequent blood sampling study before and after FFA administration
| Intervention | IU/L (Mean) |
|---|
| Aim 1-Supplementation of FFAs in an Acute or Chronic Model. | 2.33 |
| Aim 2-Hyperinsulinemic Euglycemic Clamp. | 2.4 |
C Reactive Protein (CRP) Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
C-reactive protein (CRP) is an inflammation marker produced by the liver. An increase in CRP value may means inflammation in the body. (NCT02755818)
Timeframe: "This is a cross sectional study; only one measurement collected, termed baseline"
| Intervention | mg/dL (Mean) |
|---|
| Control | 0.26 |
| Chronic Kidney Disease, Stage 5 (CKD5) | 0.74 |
| Chronic Kidney Disease, Stage 4 (CKD4) | 1.6 |
| Chronic Kidney Disease, Stage 3b (CKD3b) | 0.25 |
LDL Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
LDL (low-density lipoprotein), is a type of cholesterol (fat) circulating in the blood vessels, and can form plaques. High levels of LDL cholesterol may raise your risk for heart disease and stroke. (NCT02755818)
Timeframe: "This is a cross sectional study; only one measurement collected, termed baseline"
| Intervention | mg/dL (Mean) |
|---|
| Control | 105.93 |
| Chronic Kidney Disease, Stage 5 (CKD5) | 75.29 |
| Chronic Kidney Disease, Stage 4 (CKD4) | 235 |
| Chronic Kidney Disease, Stage 3b (CKD3b) | 112.50 |
HDL (High Density Lipoprotein) Level in Control and Chronic Kidney Disease (CKD 3b, 4, 5) Groups
"HDL (high-density lipoprotein), is called good cholesterol. It binds to cholesterols marked for disposal back to the liver to be digested and disposed by the body. High HDL level may lower your risk for heart disease and stroke." (NCT02755818)
Timeframe: "HDL (high density lipoprotein) (mg/dL) -- this is a cross sectional study; only one measurement collected, termed baseline"
| Intervention | mg/dL (Mean) |
|---|
| Control | 46.77 |
| Chronic Kidney Disease, Stage 5 (CKD5) | 38.79 |
| Chronic Kidney Disease 4 (CKD4) | 71 |
| Chronic Kidney Disease Stage 3b (CKD 3b) | 43.50 |
Body Mass Index (BMI) in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Body Mass Index (BMI) is calculated from subject's weight (kilogram) and height (meter) (NCT02755818)
Timeframe: "This is a cross sectional study; only one measurement collected, termed baseline"
| Intervention | kg/m2 (Mean) |
|---|
| Control | 25.72 |
| Chronic Kidney Disease, Stage 5 (CKD5) | 29.51 |
| Chronic Kidney Disease, Stage 4 (CKD4) | 32.87 |
| Chronic Kidney Disease, Stage 3b (CKD3b) | 26.83 |
Insulin Level in Control and Chronic Kidney Disease (CKD3b, CKD4, CKD5) Groups
Insulin is a hormone made by the pancreas that allows the body to use or store sugar (glucose) from the food eaten. Insulin regulates blood sugar level. (NCT02755818)
Timeframe: "This is a cross sectional study; only one measurement collected, termed baseline"
| Intervention | uU/mL (Mean) |
|---|
| Control | 8.52 |
| Chronic Kidney Disease, Stage 5 (CKD5) | 8.02 |
| Chronic Kidney Disease, Stage 4 (CKD4) | 8.3 |
| Chronic Kidney Disease, Stage 3b (CKD3b) | 4.9 |
Number of Participants With Pulmonary Embolism Events
Bases on imaging obtained for symptoms. (NCT02774265)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| VTE Prophylaxis With Enoxaparin 30mg BID | 6 |
| VTE Prophylaxis With Aspirin 81mg BID | 2 |
Number of Participants With Deep Venous Thromboembolism
DVT and how the diagnosis was made will be recorded. The number of events in participants in each arm will be compared to evaluate efficacy. (NCT02774265)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| VTE Prophylaxis With Enoxaparin 30mg BID | 5 |
| VTE Prophylaxis With Aspirin 81mg BID | 9 |
Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | Fatal PE | Non-fatal PE | Deep vein thrombosis (DVT) only | Fatal DVT | Non-fatal DVT | Unexplained death which VTE cannot be ruled out |
|---|
| Edoxaban | 1 | 0 | 1 | 6 | 0 | 5 | 1 |
,| Standard of Care | 1 | 0 | 1 | 1 | 0 | 0 | 1 |
Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Symptomatic recurrent VTE | PE with or without DVT | DVT only | Death as a result of VTE | Unexplained death which VTE cannot be ruled out | No change or extension of thrombotic burden |
|---|
| Edoxaban | 4 | 0 | 4 | 1 | 1 | 21 |
,| Standard of Care | 1 | 1 | 0 | 1 | 1 | 29 |
Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
Deep vein thrombosis was assessed by ultrasonography or magnetic resonance venography (MRV), catheter-related thrombosis was assessed by ultrasonography or echocardiography, sino-venous thrombosis was assessed by brain MRI, and pulmonary embolism was assessed by nuclear ventilation/perfusion (V/Q) scanning. (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Main Treatment: Participants with DVT only | Main Treatment: Participants with catheter-related thrombosis | Main Treatment: Participants with cerebral sino-venous DVT thrombosis | Main Treatment: Participants with PE with or without DVT | Extension Treatment: Participants with DVT | Extension Treatment: Participants with catheter-related thrombosis | Extension Treatment: Participants with sino-venous DVT thrombosis | Extension Treatment: Participants with PE | Overall Treatment: Participants with DVT | Overall Treatment: Participants with catheter-related thrombosis | Overall Treatment: Participants with sino-venous DVT thrombosis | Overall Treatment: Participants with PE |
|---|
| Edoxaban | 4 | 1 | 0 | 0 | 1 | 0 | 1 | 1 | 5 | 1 | 1 | 1 |
,| Standard of Care | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Symptomatic VTE | Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | Deep vein thrombosis (DVT) only |
|---|
| Edoxaban | 4 | 0 | 4 |
,| Standard of Care | 1 | 1 | 0 |
Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events. (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 25 |
| Standard of Care | 24 |
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 3 |
| Standard of Care | 5 |
Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 8 |
| Standard of Care | 5 |
Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 21 |
| Standard of Care | 29 |
Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 35 |
| Standard of Care | 47 |
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 5 |
| Standard of Care | 2 |
Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 7 |
| Standard of Care | 2 |
Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications. (NCT02798471)
Timeframe: From randomization up to Month 12
| Intervention | Participants (Count of Participants) |
|---|
| Participants with adjudicated all-cause mortality | Venous thromboembolism (VTE)-related death | Venous thromboembolism (VTE)-related death: Unexplained death which VTE cannot be ruled out | Other known causes of death | Other known causes of death: Cancer | Other known causes of death: Infectious disease | Other known causes of death: Other |
|---|
| Edoxaban | 2 | 1 | 1 | 1 | 0 | 0 | 1 |
,| Standard of Care | 3 | 1 | 1 | 2 | 1 | 1 | 0 |
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Pulmonary embolism (PE) with or without deep vein thrombosis (DVT) | Fatal PE | Non-fatal PE | Deep vein thrombosis (DVT) only | Fatal DVT | Non-fatal DVT | Unexplained death which VTE cannot be ruled out |
|---|
| Edoxaban | 0 | 0 | 0 | 5 | 0 | 4 | 1 |
,| Standard of Care | 1 | 0 | 1 | 1 | 0 | 0 | 1 |
Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: Randomization to Month 3
| Intervention | Participants (Count of Participants) |
|---|
| Death as a result of VTE | Unexplained death which VTE cannot be ruled out |
|---|
| Edoxaban | 1 | 1 |
,| Standard of Care | 1 | 1 |
Duration of Event-free Survival
Event-free survival was measured as date of randomization until treatment failure. Treatment failure was defined as failure to achieve composite completed morphological remission during the induction and re-induction phase of the study lasting up to 60 days, relapse from complete response, or death from any cause, whichever occurred first. (NCT02873338)
Timeframe: Randomization up to 30 months
| Intervention | days (Median) |
|---|
| Control (Idarubicin+Cytarabine) | 243.5 |
| Dociparstat 0.125 mg/kg | 1 |
| Dociparstat 0.25 mg/kg | 171.5 |
Number of Subjects Who Achieved Morphologic Complete Remission
Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) >1000/microliter; platelet count >100,000, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. (NCT02873338)
Timeframe: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)
| Intervention | Participants (Count of Participants) |
|---|
| Control (Idarubicin+Cytarabine) | 14 |
| Dociparstat 0.125 mg/kg | 8 |
| Dociparstat 0.25 mg/kg | 11 |
Duration of Morphologic Complete Remission
"The duration of morphologic complete remission was assessed only in subjects who had achieved morphologic complete remission and was defined as the time from achievement of complete response to the detection or relapse. Relapse was defined as the reappearance of leukemia blasts in the peripheral blood, >5% blasts in the bone marrow not attributable to another cause, or appearance/reappearance of extramedullary disease and with a bone marrow blast percentage of >5% but ≤20%. If the latter, a repeat bone marrow examination was performed at least 7 days after the first marrow examination; documentation of the bone marrow blast percentage of >5% was necessary to establish relapse. Assessments were performed every 3 months and continued until death or 18 months after the last subject was randomized, whichever occurred first.~Duration of morphologic complete remission (time from the achievement of complete response to the detection of relapse)" (NCT02873338)
Timeframe: Randomization to end of study (18 months)
| Intervention | days (Median) |
|---|
| Control (Idarubicin+Cytarabine) | 233 |
| Dociparstat 0.125 mg/kg | 494 |
| Dociparstat 0.25 mg/kg | 294 |
Number of Subjects Who Died by Day 30
Mortality (rate of death) of subjects by Day 30, measured from the first day of induction treatment to 30 days post-induction. (NCT02873338)
Timeframe: 30 days (from first day of induction treatment to 30 days after)
| Intervention | Participants (Count of Participants) |
|---|
| Control (Idarubicin+Cytarabine) | 2 |
| Dociparstat 0.125 mg/kg | 1 |
| Dociparstat 0.25 mg/kg | 3 |
Time to Platelet Recovery
Platelet recovery was measured from randomization to platelet recovery (platelet count >20,000/µL and >100,000/µL) (NCT02873338)
Timeframe: Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle
| Intervention | days (Median) |
|---|
| Recovery to >20,000µL | Recovery to >100,000µL |
|---|
| Control (Idarubicin+Cytarabine) | 35 | 38 |
,| Dociparstat 0.125 mg/kg | 36 | 50 |
,| Dociparstat 0.25 mg/kg | 29 | 32 |
Number of Subjects Who Died by Day 60.
Mortality (rate of death) of subjects by Day 60, measured from the first day of induction treatment to 60 days post-induction. (NCT02873338)
Timeframe: 60 days (from the first day of induction treatment to 60 days after)
| Intervention | Participants (Count of Participants) |
|---|
| Control (Idarubicin+Cytarabine) | 2 |
| Dociparstat 0.125 mg/kg | 2 |
| Dociparstat 0.25 mg/kg | 3 |
Number of Subjects Who Died by Day 90
Mortality (rate of death) of subjects at Day 90, measured from the first day of induction treatment to 90 days post-induction. (NCT02873338)
Timeframe: 90 days (from the first day of induction treatment to 90 days after)
| Intervention | Participants (Count of Participants) |
|---|
| Control (Idarubicin+Cytarabine) | 2 |
| Dociparstat 0.125 mg/kg | 3 |
| Dociparstat 0.25 mg/kg | 3 |
Time to Leukemia-free Survival
Leukemia-free survival was assessed as a secondary endpoint only in subjects who achieved composite complete remission and was measured from randomization until disease relapse or death from any cause, whichever occurred first. Assessments were performed every 3 months until death or 18 months after the last subject was randomized, whichever occurred first. (NCT02873338)
Timeframe: Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months
| Intervention | days (Median) |
|---|
| Control (Idarubicin+Cytarabine) | 292 |
| Dociparstat 0.125 mg/kg | 448 |
| Dociparstat 0.25 mg/kg | 166 |
Time to Recovery of Neutrophils
Neutrophil recovery was assessed from randomization to Absolute Neutrophil Count (ANC) recovery (ANC >500/µL and >1000/µL) for up to 60 days after the start of each treatment cycle. (NCT02873338)
Timeframe: Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle
| Intervention | days (Median) |
|---|
| Recovery to >500/µL | Recovery to >1000/µL |
|---|
| Control (Idarubicin+Cytarabine) | 32 | 37 |
,| Dociparstat 0.125 mg/kg | 43 | 42 |
,| Dociparstat 0.25 mg/kg | 29 | 35 |
Number of Subjects Who Achieved Composite Complete Remission
The composite complete remission (CR) rate included CR, CR without recovery of platelets (CRp), and CR without recovery of neutrophils and/or platelets (CRi), as defined by the International Working Group criteria during the induction and re-induction phases of treatment. CR was defined as an Absolute Neutrophil Count (ANC) >1000/μL, platelet count >100,000/μL, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. CRi was defined as an ANC <1000/μL and/or platelet count <100,000/, <5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease. (NCT02873338)
Timeframe: Up to 60 days after the start of each treatment cycle
| Intervention | Participants (Count of Participants) |
|---|
| Control (Idarubicin+Cytarabine) | 16 |
| Dociparstat 0.125 mg/kg | 9 |
| Dociparstat 0.25 mg/kg | 15 |
Number of Rate Adjustments
Heparin rate adjustments were made for out of range anti-Xa levels (<0.1 and >0.35) (NCT02970032)
Timeframe: Through study completion, an average of 1 year.
| Intervention | Rate adjustments (Mean) |
|---|
| Standard Heparin Dose Followed by Dose Adjustment | 4.5 |
Number of Participants With Anti-Xa Levels Within Target Range (0.1-0.35 IU/mL)
Anti-Xa levels are used to monitor anticoagulant therapy. (NCT02970032)
Timeframe: Through study completion, an average of 1 year.
| Intervention | Participants (Count of Participants) |
|---|
| Standard Heparin Dose | Dose adjustment |
|---|
| Standard Heparin Dose Followed by Dose Adjustment | 0 | 12 |
The Number of Participants With Adjudicated CRNM Bleeding
"The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:~overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition~bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 1 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 2 |
The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
"Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.~PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).~Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems." (NCT02981472)
Timeframe: from randomization up to 12 months after randomization
| Intervention | Score on a scale (Mean) |
|---|
| GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - BASELINE | GENERAL-SPECIFIC MODULE ASSESSED BY CHILD - MONTH 12 | GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - BASELINE | GENERAL-SPECIFIC MODULE ASSESSED BY PARENT - MONTH 12 | HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - BASELINE | HEART PROBLEMS AND TREATMENT ASSESSED BY CHILD - MONTH 12 | TREATMENT II ASSESSED BY CHILD - BASELINE | TREATMENT II ASSESSED BY CHILD - MONTH 12 | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - BASELINE | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY CHILD - MONTH 12 | TREATMENT ANXIETY ASSESSED BY CHILD - BASELINE | TREATMENT ANXIETY ASSESSED BY CHILD - MONTH 12 | COGNITIVE PROBLEMS ASSESSED BY CHILD - BASELINE | COGNITIVE PROBLEMS ASSESSED BY CHILD - MONTH 12 | COMMUNICATION ASSESSED BY CHILD - BASELINE | COMMUNICATION ASSESSED BY CHILD - MONTH 12 | HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - BASELINE | HEART PROBLEMS AND TREATMENT ASSESSED BY PARENT - MONTH 12 | TREATMENT II ASSESSED BY PARENT - BASELINE | TREATMENT II ASSESSED BY PARENT - MONTH 12 | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - BASELINE | PERCEIVED PHYSICAL APPEARANCE ASSESSED BY PARENT - MONTH 12 | TREATMENT ANXIETY ASSESSED BY PARENT - BASELINE | TREATMENT ANXIETY ASSESSED BY PARENT - MONTH 12 | COGNITIVE PROBLEMS ASSESSED BY PARENT - BASELINE | COGNITIVE PROBLEMS ASSESSED BY PARENT - MONTH 12 | COMMUNICATION ASSESSED BY PARENT - BASELINE | COMMUNICATION ASSESSED BY PARENT - MONTH 12 |
|---|
| Apixaban | 69.64 | 73.37 | 65.61 | 70.00 | 65.34 | 69.46 | 87.39 | 91.77 | 75.51 | 80.56 | 80.52 | 80.71 | 69.85 | 68.24 | 66.15 | 70.31 | 63.68 | 66.37 | 91.41 | 90.30 | 79.16 | 79.38 | 61.44 | 64.03 | 60.29 | 58.69 | 65.57 | 68.20 |
,| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 60.71 | 64.81 | 65.42 | 70.32 | 64.70 | 63.44 | 85.68 | 86.27 | 78.44 | 81.37 | 60.31 | 60.31 | 53.24 | 53.53 | 63.55 | 57.28 | 67.71 | 69.00 | 85.27 | 83.80 | 79.66 | 74.33 | 56.27 | 57.77 | 61.60 | 58.53 | 67.33 | 66.17 |
The Number of Participants With Adjudicated Major Bleeding
"The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding is defined as bleeding that satisfies one or more of the following criteria:~fatal bleeding~clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period~bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS~bleeding that requires surgical intervention in an operating suite, including interventional radiology" (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 1 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 1 |
Chromogenic FX Assay (Apparent FX Level)
"Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.~125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | Percent (Mean) |
|---|
| Day 1 (PREDOSE) | Day 1 (4 HRS POSTDOSE) | Week 2 (PREDOSE) | Week 2 (2 HRS POSTDOSE) | Month 3 (2 HRS POSTDOSE) | Month 6 (PREDOSE) |
|---|
| Apixaban | 58.87 | 18.90 | 35.88 | 21.26 | 18.25 | 36.57 |
Anti-FXa Activity
"Anti-FXa Activity was measured to assess participant plasma apixaban levels.~125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below." (NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | ng/mL (Mean) |
|---|
| Day 1 (4 HRS POSTDOSE) | Week 2 (PREDOSE) | Week 2 (2 HRS POSTDOSE) | Month 3 (2 HRS POSTDOSE) | Month 6 (PREDOSE) |
|---|
| Apixaban | 147.69 | 86.24 | 242.34 | 228.88 | 66.93 |
Trough Observed Concentration (Cmin)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | ng/mL (Geometric Mean) |
|---|
| Participants Weight Range 6 to < 9 kg | 57.9 |
| Participants Weight Range 9 to < 12 kg | 82.7 |
| Participants Weight Range 12 to < 18 kg | 64.3 |
| Participants Weight Range 18 to < 25 kg | 67.4 |
| Participants Weight Range 25 to < 35 kg | 73.1 |
| Participants Weight Range ≥ 35 kg | 72.7 |
Time of Maximum Observed Concentration (Tmax)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | hours (Median) |
|---|
| Participants Weight Range 6 to < 9 kg | 2.24 |
| Participants Weight Range 9 to < 12 kg | 2.47 |
| Participants Weight Range 12 to < 18 kg | 1.72 |
| Participants Weight Range 18 to < 25 kg | 1.74 |
| Participants Weight Range 25 to < 35 kg | 1.65 |
| Participants Weight Range ≥ 35 kg | 1.85 |
The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 7 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 1 |
The Number of Participants With All Adjudicated Bleeding
The number of participants with all adjudicated bleeding events (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 47 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 23 |
The Number of Participant Deaths in the Study
The number of participant deaths in the study. (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 0 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 0 |
Maximum Observed Concentration (Cmax)
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | ng/mL (Geometric Mean) |
|---|
| Participants Weight Range 6 to < 9 kg | 185 |
| Participants Weight Range 9 to < 12 kg | 218 |
| Participants Weight Range 12 to < 18 kg | 222 |
| Participants Weight Range 18 to < 25 kg | 244 |
| Participants Weight Range 25 to < 35 kg | 249 |
| Participants Weight Range ≥ 35 kg | 203 |
Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
"The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).~Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.~CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room." (NCT02981472)
Timeframe: From first dose to 2 days after last dose (Up to approximately 12 months)
| Intervention | Participants (Count of Participants) |
|---|
| Apixaban | 1 |
| Low Molecular Weight Heparin (LMWH)/Vitamin K Antagonists (VKA) | 3 |
Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
(NCT02981472)
Timeframe: From first dose up to 6 months after first dose
| Intervention | ng • h/mL (Geometric Mean) |
|---|
| Participants Weight Range 6 to < 9 kg | 1460 |
| Participants Weight Range 9 to < 12 kg | 1840 |
| Participants Weight Range 12 to < 18 kg | 1610 |
| Participants Weight Range 18 to < 25 kg | 1760 |
| Participants Weight Range 25 to < 35 kg | 1840 |
| Participants Weight Range ≥ 35 kg | 1630 |
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | ng.h/mL (Mean) |
|---|
| Treatment B | 783.5 |
| Treatment C | 2782.2 |
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; MAGNESIUM, SERUM MG MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
| Intervention | Participants (Count of Participants) |
|---|
| Calcium, Total (MG/DL) Abnormal low | Calcium, Total (MG/DL) Abnormal high | Phosphorus, Inorganic (MG/DL) Abnormal low | Phosphorus, Inorganic (MG/DL) Abnormal high | Magnesium, Serum (MEQ/L), Abnormal low | Magnesium, Serum (MEQ/L), Abnormal high | Magnesium, Serum (MEQ/L), Not reported |
|---|
| Treatment A | 1 | 0 | 2 | 0 | 1 | 0 | 0 |
,| Treatment B | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Treatment C | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Treatment D | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW < 0.95*LLN IF PRE-RX IS MISSING; < 0.95*LLN IF PRE-RX >= LLN; < 0.95*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.05*ULN IF PRE-RX IS MISSING; > 1.05*ULN IF PRE-RX <= ULN; > 1.05*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge
| Intervention | Participants (Count of Participants) |
|---|
| Sodium, Serum (MEQ/L), Abnormal low | Sodium, Serum (MEQ/L), Abnormal high | Potassium, Serum (MEQ/L), Abnormal low | Potassium, Serum (MEQ/L), Abnormal high | Potassium, Serum (MEQ/L), Not reported | Chloride, Serum (MEQ/L) Abnormal low | Chloride, Serum (MEQ/L) Abnormal high | Chloride, Serum (MEQ/L) Not reported |
|---|
| Treatment A | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
,| Treatment B | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Treatment C | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
,| Treatment D | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
URINALYSIS I; BLOOD, URINE UBLD N/A HIGH >= 2 IF PRE-RX IS MISSING; >= 2 IF PRE-RX < 1; >= 2 IF PRE-RX >= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
| Intervention | Participants (Count of Participants) |
|---|
| Blood, Urine (N/A) Abnormal high | Occult Blood Screen, Feces (N/A) Abnormal high |
|---|
| Treatment A | 0 | 0 |
,| Treatment B | 1 | 0 |
,| Treatment C | 1 | 0 |
,| Treatment D | 0 | 0 |
Pharmacokinetic Parameters of BMS-986177: Cmax
Cmax: Maximum observed plasma concentration (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | ng/mL (Mean) |
|---|
| Treatment B | 1120 |
| Treatment C | 3342 |
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
LIVER & KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.2*PRE-RX IF PRE-RX > ULN; CREATININE CREAT MG/DL HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.33*PRE-RX IF PRE-RX > ULN; (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
| Intervention | Participants (Count of Participants) |
|---|
| ALP (U/L) Abnormal high | AST (U/L) Abnormal high | AST (U/L) Not reported | ALT (U/L) Abnormal high | Bilirubin, Total (MG/DL) Abnormal high | Bilirubin, Direct (MG/DL) Abnormal high | Bilirubin, Direct (MG/DL), Not reported | Blood Urea Nitrogen (MG/DL) Abnormal high | Creatinine (MG/DL) Abnormal high | Creatinine (MG/DL) Not reported |
|---|
| Treatment A | 1 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 1 |
,| Treatment B | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
,| Treatment C | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
,| Treatment D | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 |
The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death (NCT03000673)
Timeframe: From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)
| Intervention | Participants (Number) |
|---|
| Adverse Events | Serious Adverse Events | Adverse Events Leading to Discontinuations | Deaths |
|---|
| Treatment A | 2 | 0 | 0 | 0 |
,| Treatment B | 4 | 0 | 0 | 0 |
,| Treatment C | 4 | 0 | 0 | 0 |
,| Treatment D | 3 | 0 | 0 | 0 |
The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
(NCT03000673)
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
| Intervention | beats/min (Mean) |
|---|
| 3 hours post hemodialysis | 24 hours post dose |
|---|
| Treatment A | 3.3 | NA |
,| Treatment B | 4.9 | 4.2 |
,| Treatment C | 4.0 | 1.1 |
,| Treatment D | 4.5 | NA |
The Change From Baseline in Vital Signs: Diastolic Blood Pressure
(NCT03000673)
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
| Intervention | mmHg (Mean) |
|---|
| 3 hours post Hemodialysis | 24 hours post dose |
|---|
| Treatment A | 0.5 | NA |
,| Treatment B | -3.7 | -2.8 |
,| Treatment C | 0.2 | -2.2 |
,| Treatment D | 0.1 | NA |
The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
(NCT03000673)
Timeframe: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
| Intervention | mmHg (Mean) |
|---|
| 3 hours post hemodialysis | 24 hours post dose |
|---|
| Treatment A | -5.8 | NA |
,| Treatment B | -6.6 | -8.4 |
,| Treatment C | 1.1 | -9.2 |
,| Treatment D | -0.2 | NA |
Pharmacokinetic Parameters of BMS-986177: Tmax
Time of maximum observed plasma concentration (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | h (Mean) |
|---|
| Treatment B | 4.531 |
| Treatment C | 4.855 |
The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. (NCT03000673)
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12
| Intervention | msec (Mean) |
|---|
| Day 1 | Day 5 | Day 8 | Day 12 |
|---|
| Treatment A | 5.7 | 9.9 | -2.1 | 1.0 |
,| Treatment B | -3.2 | 5.1 | -1.3 | 2.1 |
,| Treatment C | 1.7 | -4.9 | 6.2 | -9.9 |
,| Treatment D | -1.0 | -0.6 | 0.3 | 0.8 |
The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. (NCT03000673)
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.
| Intervention | msec (Mean) |
|---|
| Day 1 | Day 5 | Day 8 | Day 12 |
|---|
| Treatment A | 3.9 | 5.6 | -7.4 | -2.2 |
,| Treatment B | -3.7 | 8.4 | -1.8 | 0.7 |
,| Treatment C | -1.6 | -7.4 | 12.0 | -14.9 |
,| Treatment D | -3.1 | -2.8 | -3.6 | -0.7 |
The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. (NCT03000673)
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.
| Intervention | msec (Mean) |
|---|
| Day 1 | Day 5 | Day 8 | Day 12 |
|---|
| Treatment A | -3.1 | 0.6 | 0.3 | 2.0 |
,| Treatment B | -1.1 | -0.3 | -0.2 | 0.9 |
,| Treatment C | 5.7 | -0.2 | -1.8 | -0.1 |
,| Treatment D | -0.2 | -0.2 | -0.7 | -0.7 |
The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. (NCT03000673)
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.
| Intervention | msec (Mean) |
|---|
| Day 1 | Day 5 | Day 8 | Day 12 |
|---|
| Treatment A | 13.6 | -25.4 | -3.4 | -2.6 |
,| Treatment B | -1.3 | 12.6 | -1.2 | -27.7 |
,| Treatment C | -25.0 | -5.8 | 12.7 | -5.6 |
,| Treatment D | -6.9 | -5.1 | -22.6 | 8.8 |
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
"AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis.~Determined from blood samples entering and exiting the dialyzer)" (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | ng.h/mL (Mean) |
|---|
| Treatment B | 2847.4 |
| Treatment C | 8558.1 |
The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication. (NCT03000673)
Timeframe: Days -3 to -1, Days 1, 5, 8, and 12.
| Intervention | Beats/min (Mean) |
|---|
| Day 1 | Day 5 | Day 8 | Day 12 |
|---|
| Treatment A | -0.1 | 1.6 | 4.0 | 1.4 |
,| Treatment B | 1.8 | -2.1 | 0.0 | 0.4 |
,| Treatment C | 1.4 | 2.0 | -2.8 | 3.9 |
,| Treatment D | 0.4 | 2.0 | 2.3 | 0.8 |
The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85*PRE-RX; HEMATOCRIT HCT % LOW < 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; HIGH > 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF LLN <= PRE-RX <= ULN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF LLN <= PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW < 1.5 IF PRE-RX IS MISSING; < 1.5 IF PRE-RX >= 1.5; < 0.85*PRE-RX IF; PRE-RX < 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW < 0.75; HIGH > 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH > 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH > 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH > 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH > 1.5*ULN; APTT APTT SEC HIGH > 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH > 1.5*ULN; (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
| Intervention | Participants (Count of Participants) |
|---|
| Hematology I Hemoglobin (G/DL) Abnormal low | Hematocrit (%) Abnormal low | Platelet Count (X10*9 C/L) Abnormal low | Leukocytes (X10*3 C/UL) Abnormal low | Leukocytes (X10*3 C/UL): Abnormal high | Neutrophils (Absolute) (X10*3 C/UL) | Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low | Monocytes (Absolute) (X10*3 C/UL) Abnormal high | Basophils (Absolute) (X10*3 C/UL) Abnormal high | Eosinophils (Absolute) (X10*3 C/UL) | Prothrombin time (PT) (sec): Abnormal high | APTT (sec): Abnormal high | APTT (sec): Not reported | INR (fraction): Abnormal high |
|---|
| Treatment A | 1 | 2 | 1 | 2 | 1 | 1 | 5 | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
,| Treatment B | 3 | 3 | 1 | 2 | 0 | 0 | 3 | 0 | 0 | 1 | 1 | 4 | 1 | 0 |
,| Treatment C | 3 | 4 | 1 | 1 | 0 | 0 | 4 | 0 | 0 | 1 | 1 | 25 | 0 | 0 |
,| Treatment D | 2 | 2 | 2 | 0 | 1 | 2 | 3 | 0 | 0 | 2 | 2 | 1 | 0 | 0 |
Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)
AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | ng.h/mL (Mean) |
|---|
| AUC (0-T) | AUC (0-24) |
|---|
| Treatment B | 10406.6 | 10533.4 |
,| Treatment C | 36112.9 | 34028.0 |
Pharmacokinetic Parameters of BMS-986177: fu
Fraction of unbound drug (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | Percentage (Mean) |
|---|
| Treatment B | 7.644 |
| Treatment C | 7.868 |
Pharmacokinetic Parameters of BMS-986177: Cmaxfu
Maximum observed plasma concentration of free drug (NCT03000673)
Timeframe: Either Day 1, 5, 8, or 12 depending on the randomization sequence
| Intervention | ng/mL (Mean) |
|---|
| Treatment B | 84.32 |
| Treatment C | 257.9 |
The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
GLUCOSE, FASTING SERUM GLUCF MG/DL LOW < 0.8*LLN IF PRE-RX IS MISSING; < 0.8*LLN IF PRE-RX >= LLN; < 0.8*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.3*ULN IF PRE-RX IS MISSING > 1.3*ULN IF PRE-RX <= ULN; > 2*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PROTEIN, TOTAL TPRO G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; ALBUMIN ALB G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; CREATINE KINASE (CK) CK U/L HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; URIC ACID URIC MG/DL HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; LACTATE DEHYDR (LD) LD U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN (NCT03000673)
Timeframe: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
| Intervention | Participants (Count of Participants) |
|---|
| Glucose, Fasting serum (MG/DL) Abnormal low | Glucose, Fasting serum (MG/DL) Abnormal high | Protein, Total (G/DL) Abnormal low | Protein, Total (G/DL) Abnormal high | Albumin (G/DL) Abnormal low | Creatine Kinase (CK) (U/L) Abnormal high | Creatine Kinase (CK) (U/L) Not reported | Uric Acid (MG/DL) Abnormal High | LD (U/L) Abnormal high | LD (U/L) Not reported |
|---|
| Treatment A | 1 | 4 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
,| Treatment B | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Treatment C | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Treatment D | 1 | 4 | 1 | 0 | 1 | 0 | 1 | 0 | 3 | 1 |
Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms
Patients in each arm receiving postoperative diagnostic imaging for venous thromboembolism relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral CT angiography, V/Q scan). (NCT03006562)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Subcutaneous Heparin | 25 |
| Control | 31 |
Estimated Blood Loss During Surgery
The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery. (NCT03006562)
Timeframe: During surgery (usually between 2-3 hours of operative time)
| Intervention | milliliters (Median) |
|---|
| Subcutaneous Heparin | 150 |
| Control | 200 |
Number of Participants With Major Postoperative Bleeding
This additional primary outcome includes the development and diagnosis of any major clinically recognized bleeding event within 30 days after surgery requiring >1 unit of packed red blood cell transfusion, intervention to stop bleeding, or return to the operating room. (NCT03006562)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Subcutaneous Heparin | 4 |
| Control | 2 |
Number of Participants With Occurrence of Any Venous Thromboembolism
DVT or PE diagnosed for any reason within 30 days after surgery. This includes any diagnosed DVT or PE as described in the primary outcome plus any additional DVTs or PEs diagnosed at 30 day screening lower extremity ultrasound for patients opting to undergo screening bilateral lower extremity Duplex ultrasound at 30 days who do not have symptoms. (NCT03006562)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Subcutaneous Heparin | 4 |
| Control | 4 |
Number of Participants With Symptomatic Postoperative Fluid Collection
This outcome is defined as a surgical or pelvic fluid collection diagnosed as a hematoma (blood collection, with or without infection) or lymphocele (collection of lymph fluid in the pelvis) due to symptoms (fever, abdominal pain, nausea or vomiting, anemia, high surgical drain output) within 30 days after surgery. (NCT03006562)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Subcutaneous Heparin | 10 |
| Control | 9 |
Number of Participants With Symptomatic Venous Thromboembolism
Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum). (NCT03006562)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Subcutaneous Heparin | 2 |
| Control | 5 |
Surgical Drain Output After Surgery
The total output in milliliters from any surgical drain left in place (not all patients will necessarily have a surgical drain) after surgery and until discharge from the hospital (usually 1 to 2 days). Drain output, if one is left in place after discharge, will not count toward this secondary outcome. (NCT03006562)
Timeframe: Over length of stay in hospital (usually 1 to 2 days)
| Intervention | milliliters (Median) |
|---|
| Subcutaneous Heparin | 95 |
| Control | 100 |
Consent
Proportion of eligible subjects who provide consent. (NCT03100123)
Timeframe: 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Consented Eligible Patients | 1 |
Crossover Rate
Crossover rate between standard of care and experimental study arms. (NCT03100123)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Crossover Rate | 0 |
Eligibility
Proportion of screened patients who meet eligibility criteria (i.e. patients who meet inclusion criteria and are also eligible based on exclusion criteria). (NCT03100123)
Timeframe: 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Screened Patients Who Met Eligibility Criteria | 4 |
Withdrawals/Loss to Follow-up
Proportion of withdrawals/loss to follow-up among randomized patients. (NCT03100123)
Timeframe: 24 months
| Intervention | Participants (Count of Participants) |
|---|
| Withdrawal/Lost to Follow-up | 0 |
Study Feasibility: Mean Recruitment Rate Per Center Per Month
The primary feasibility outcome of the pilot trial is the mean recruitment rate per center per month. (NCT03100123)
Timeframe: 24 months
| Intervention | participants (Number) |
|---|
| Experimental Arm | 1 |
Study Drug Compliance
Level of compliance with study drug through patient recall and patient medication diary. (NCT03100123)
Timeframe: 52 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Standard of Care Arm | 0 |
| Experimental Arm | 1 |
Essential Documents
Proportion of sites requiring >18 months to obtain all required approvals/contracts from time of delivery of all study documents. (NCT03100123)
Timeframe: 18 months
| Intervention | Sites (Number) |
|---|
| Approval Timeline | 1 |
Nomogram Feasibility
Questionnaires evaluating pragmatic application of nomograms. Question 2: Overall, I am satisfied with the utilization and implementation of the heparin monitoring nomogram. (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | Surveys (Number) |
|---|
| Surveys Completed | Affirmative Responses |
|---|
| Anti-factor Xa Nomogram | 112 | 112 |
,| aPTT Nomogram | 136 | 136 |
Dosing Changes
Number of dosing changes during heparin therapy until first therapeutic (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | dosing changes (Median) |
|---|
| aPTT Nomogram | 4.0 |
| Anti-factor Xa Nomogram | 3.0 |
Success of Nomogram
Amount of time sustained in therapeutic anticoagulation range (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | % of time patients test was therapeutic (Median) |
|---|
| aPTT Nomogram | 39.8 |
| Anti-factor Xa Nomogram | 55.8 |
Time to Therapeutic Dose
Amount of time needed to achieve therapeutic dose from heparin initiation (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | hours (Median) |
|---|
| aPTT Nomogram | 48.0 |
| Anti-factor Xa Nomogram | 33.0 |
Nomogram Feasibility
Questionnaires evaluating pragmatic application of nomograms. Question 1: The current heparin nomogram using (aPTT or anti-Xa depending on group) monitoring is easy to follow. (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | Surveys (Number) |
|---|
| Surveys Completed | Affirmative Responses |
|---|
| Anti-factor Xa Nomogram | 112 | 111 |
,| aPTT Nomogram | 136 | 136 |
Nomogram Feasibility
Questionnaires evaluating pragmatic application of nomograms. Question 3: Overall, I feel that this dosing nomogram is feasible. (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | Surveys (Number) |
|---|
| Surveys Completed | Affirmative Responses |
|---|
| Anti-factor Xa Nomogram | 112 | 112 |
,| aPTT Nomogram | 136 | 135 |
Nomogram Feasibility
Questionnaires evaluating pragmatic application of nomograms. Question 4: When my patient is on the heparin nomogram, I follow the dosing and monitoring instructions exactly. (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | Surveys (Number) |
|---|
| Surveys Completed | Affirmative Responses |
|---|
| Anti-factor Xa Nomogram | 112 | 112 |
,| aPTT Nomogram | 136 | 136 |
Nomogram Feasibility
Questionnaires evaluating pragmatic application of nomograms. Question 5: I often had to seek clarification from a coworker, pharmacist, NP, or MD regarding the nomogram instructions. (NCT03143569)
Timeframe: 14 days of heparin therapy
| Intervention | Surveys (Number) |
|---|
| Surveys Completed | Affirmative Responses |
|---|
| Anti-factor Xa Nomogram | 112 | 22 |
,| aPTT Nomogram | 136 | 45 |
Number of Blood Products Transfused
Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate (NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks
| Intervention | mls/kg/day (Median) |
|---|
| pRBCs | Platelets | FFP | Cryoprecipitate |
|---|
| Bivalirudin Group | 6.29 | 4.55 | 1.15 | 0.1 |
,| Unfractionated Heparin Group | 12.2 | 13.58 | 0.16 | 0 |
Percentage of Time Spent at Goal Anticoagulation
(NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks
| Intervention | percentage of time (Median) |
|---|
| Unfractionated Heparin Group | 0.63 |
| Bivalirudin Group | 0.49 |
Number of Participants With One or More Major Bleeding Events
Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding (NCT03318393)
Timeframe: through study completion, an average of 1-2 weeks
| Intervention | participants (Number) |
|---|
| Unfractionated Heparin Group | 7 |
| Bivalirudin Group | 7 |
Number of Participants With Adjudicated Bleeding Events Within the Main Treatment Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of >2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding. (NCT03395639)
Timeframe: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
| Intervention | Participants (Count of Participants) |
|---|
| Major or CRNM bleeding events | Major bleeding events | All bleeding events (Major, CRNM, minor) |
|---|
| Edoxaban | 1 | 0 | 4 |
,| Standard of Care (SOC) | 1 | 0 | 2 |
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). (NCT03395639)
Timeframe: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
| Intervention | Participants (Count of Participants) |
|---|
| Thromboembolic event, Any Event | Deep vein thrombosis | Pulmonary embolism | Stroke | Systemic embolic event | Intracardiac thrombus | Myocardial infarction | Asymptomatic intracardiac thrombus identified by cardiac imaging | Death as a result of TE |
|---|
| Edoxaban | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Standard of Care (SOC) | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Symptomatic Thromboembolic Events (TE) in the Systemic Arterial or Venous Pathways During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). (NCT03395639)
Timeframe: Month 4 up to Month 13
| Intervention | Participants (Count of Participants) |
|---|
| Thromboembolic event, Any Event | Deep vein thrombosis | Pulmonary embolism | Stroke | Systemic embolic event | Intracardiac thrombus | Myocardial infarction | Asymptomatic intracardiac thrombus identified by cardiac imaging | Death as a result of TE |
|---|
| Edoxaban | 4 | 0 | 0 | 2 | 0 | 0 | 2 | 0 | 0 |
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) During the Extension Period
Death due to any cause (all-cause mortality) was assessed. (NCT03395639)
Timeframe: Month 4 up to Month 13
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 2 |
Number of Participants Who Died as a Result of Any Cause (All-Cause Mortality) Within the Main Treatment Period
Death due to any cause (all-cause mortality) was assessed. (NCT03395639)
Timeframe: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 0 |
| Standard of Care (SOC) | 0 |
Number of Participants Who Died as a Result of Thromboembolic Event During the Extension Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). (NCT03395639)
Timeframe: Month 4 up to Month 13
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 0 |
Number of Participants Who Died as a Result of Thromboembolic Event Within the Main Treatment Period
Symptomatic thromboembolic events (TE) in the systemic arterial or venous pathways include deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac thrombus, and myocardial infarction (MI). (NCT03395639)
Timeframe: Date of first dose of study drug up to the Month 4 or to the date of last dose of study drug if study treatment was discontinued, whichever was earlier
| Intervention | Participants (Count of Participants) |
|---|
| Edoxaban | 0 |
| Standard of Care (SOC) | 0 |
Number of Participants With Adjudicated Bleeding Events During the Extension Period
Adjudicated bleeding events included major and clinically-relevant non-major (CRNM) bleeding events per International Society on Thrombosis and Haemostasis (ISTH) definition occurring within the main treatment period. Based on modified ISTH recommendations, major bleeding is defined as a composite (ie, any) of the following: fatal bleeding; and/or symptomatic bleeding in a critical area or organ; and/or bleeding causing a decrease in hemoglobin level of >2 g/dL, or leading to transfusion of the equivalent of ≥2 units of whole blood or red cells. A CRNM bleed is an acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding, or a physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy. Minor bleeding is any other overt bleeding event that does not meet criteria for either major or CRNM bleeding. (NCT03395639)
Timeframe: Month 4 up to Month 13
| Intervention | Participants (Count of Participants) |
|---|
| Major or CRNM bleeding events | Major bleeding events | All bleeding events (Major, CRNM, minor) |
|---|
| Edoxaban | 1 | 1 | 4 |
Off Study Use of t-PA
off study use (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | doses (Median) |
|---|
| Alteplase | 0.5 |
| Heparin | 0 |
Episodes of CVC Dysfunction
Episodes of CVC dysfunction (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | episodes (Number) |
|---|
| Alteplase | 5 |
| Heparin | 2 |
Clinical Bleeding
clinically significant bleeding (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | episodes (Number) |
|---|
| Alteplase | 0 |
| Heparin | 0 |
Catheter-associated Venous Thrombosis
Catheter-associated Venous Thrombosis upon ICU discharge or 30 days (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | Participants (Count of Participants) |
|---|
| Alteplase | 3 |
| Heparin | 3 |
Catheter-associated Bloodstream Infection
CLABSI (NCT03672006)
Timeframe: 30 days or ICU discharge
| Intervention | Participants (Count of Participants) |
|---|
| Alteplase | 0 |
| Heparin | 0 |
Adverse Clinical Events
Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding (NCT03772613)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Low ACT Target | 2 |
| Medium ACT Target | 0 |
| High ACT Target | 2 |
Bleeding
Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V) (NCT03772613)
Timeframe: From date of randomization until the date of first documented bleeding event up to 24 hours
| Intervention | Participants (Count of Participants) |
|---|
| Low ACT Target | 14 |
| Medium ACT Target | 15 |
| High ACT Target | 15 |
Stent Thrombosis
Number of subjects to experience stent thrombosis (NCT03772613)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Low ACT Target | 1 |
| Medium ACT Target | 0 |
| High ACT Target | 0 |
Provider Adherence in Implementation of PE Prevention Strategies.
Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result. (NCT03862755)
Timeframe: Through study completion, an average of 1 month
| Intervention | Participants (Count of Participants) |
|---|
| Compliance | Non-compliance |
|---|
| Thromboprophylaxis | 306 | 275 |
Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE. (NCT03862755)
Timeframe: up to 8 weeks post operation
| Intervention | Participants (Count of Participants) |
|---|
| Thromboprophylaxis | 3 |
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
(NCT04042324)
Timeframe: 8 hours
| Intervention | h*ug/dL (Geometric Mean) |
|---|
| Triferic Post-dialyzer; UFH Via Continuous Infusion | 1040 |
| UFH and Triferic Admixture | 1050 |
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
(NCT04042324)
Timeframe: 4 hours
| Intervention | IU*hr/mL (Geometric Mean) |
|---|
| Triferic Post-dialyzer; UFH Via Continuous Infusion | 97.6 |
| UFH and Triferic Admixture | 98.0 |
| UFH Via Continuous Infusion Pre-dialyzer | 104 |
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
(NCT04042324)
Timeframe: 8 hours
| Intervention | ug/dL (Geometric Mean) |
|---|
| Triferic Post-dialyzer; UFH Via Continuous Infusion | 180 |
| UFH and Triferic Admixture | 174 |
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
(NCT04042324)
Timeframe: 4 hours
| Intervention | IU*hr/mL (Geometric Mean) |
|---|
| Triferic Post-dialyzer; UFH Via Continuous Infusion | 188 |
| UFH and Triferic Admixture | 196 |
| UFH Via Continuous Infusion Pre-dialyzer | 188 |
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
(NCT04042324)
Timeframe: 8 hours
| Intervention | IU*hr/mL (Geometric Mean) |
|---|
| UFH and Triferic Admixture | .798 |
| UFH Via Continuous Infusion Pre-dialyzer | .733 |
Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
(NCT04042324)
Timeframe: 4 hours
| Intervention | IU*hr/mL (Geometric Mean) |
|---|
| Triferic Post-dialyzer; UFH Via Continuous Infusion | .581 |
| UFH and Triferic Admixture | .600 |
| UFH Via Continuous Infusion Pre-dialyzer | .538 |
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples. (NCT04355728)
Timeframe: day 14 post first infusion
| Intervention | Participants (Count of Participants) |
|---|
| IgM72513537 | IgM72513536 | IgG72513536 | IgG72513537 |
|---|
| Positive | Negative | Borderline |
|---|
| UC-MSCs Group | 2 |
| Control Group | 2 |
| Control Group | 0 |
| UC-MSCs Group | 1 |
| UC-MSCs Group | 4 |
| UC-MSCs Group | 0 |
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Total number of adverse events and serious adverse events as assessed by treating physician (NCT04355728)
Timeframe: 90 days
| Intervention | Adverse Events (Number) |
|---|
| Number of Adverse Events (not including SAEs) | Number of Serious Adverse Events |
|---|
| Control Group | 37 | 16 |
,| UC-MSCs Group | 40 | 6 |
Survival at 60 Days Post First Infusion
Number of participants alive at 60 days post first infusion follow up. (NCT04355728)
Timeframe: 60 days
| Intervention | Participants (Count of Participants) |
|---|
| UC-MSCs Group | 9 |
| Control Group | 5 |
Survival at 31 Days Post First Infusion
Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion. (NCT04355728)
Timeframe: 31 Days
| Intervention | Participants (Count of Participants) |
|---|
| UC-MSCs Group | 10 |
| Control Group | 5 |
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma (NCT04355728)
Timeframe: day 6
| Intervention | pg/mL (Mean) |
|---|
| UC-MSCs Group | 26609.09 |
| Control Group | 23111.11 |
Carbon Dioxide (CO2)
Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel. (NCT04355728)
Timeframe: day 6
| Intervention | mmol/L (Mean) |
|---|
| UC-MSCs Group | 28.44 |
| Control Group | 26.44 |
Calcium
Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel. (NCT04355728)
Timeframe: day 6
| Intervention | mg/dL (Mean) |
|---|
| UC-MSCs Group | 8.5 |
| Control Group | 8.27 |
Number of Subjects With Serious Adverse Events by 31 Days After First Infusion
The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion). (NCT04355728)
Timeframe: 31 days
| Intervention | Participants (Count of Participants) |
|---|
| UC-MSCs Group | 2 |
| Control Group | 8 |
Alkaline Phosphatase
Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel. (NCT04355728)
Timeframe: day 6
| Intervention | U/L (Mean) |
|---|
| UC-MSCs Group | 136.2 |
| Control Group | 202.5 |
25-Hydroxy Vitamin D Levels
As assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | ng/ml (Mean) |
|---|
| UC-MSCs Group | 23.21 |
| Control Group | 27.58 |
Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | U/L (Mean) |
|---|
| UC-MSCs Group | 64.4 |
| Control Group | 65.67 |
Albumin
Albumin levels as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | g/dL (Mean) |
|---|
| UC-MSCs Group | 2.96 |
| Control Group | 2.73 |
Lymphocytes
Lymphocyte count as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | 10^3 cells/uL (Mean) |
|---|
| UC-MSCs Group | 1.38 |
| Control Group | 0.8 |
Neutrophils
the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | 10^3 cells/uL (Mean) |
|---|
| UC-MSCs Group | 9.74 |
| Control Group | 13.4 |
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. (NCT04355728)
Timeframe: day 14
| Intervention | Participants (Count of Participants) |
|---|
| Class I72513536 | Class I72513537 | Class II72513536 | Class II72513537 |
|---|
| PRA Positive | PRA Negative |
|---|
| UC-MSCs Group | 5 |
| Control Group | 3 |
| UC-MSCs Group | 0 |
| Control Group | 1 |
| UC-MSCs Group | 4 |
| UC-MSCs Group | 1 |
| Control Group | 2 |
Sodium
Sodium levels as assessed by serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | mmol/L (Mean) |
|---|
| UC-MSCs Group | 141.22 |
| Control Group | 141 |
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
As assessed via serum blood samples on day 6 (visit 8). (NCT04355728)
Timeframe: day 6
| Intervention | ratio of AA to EPA (Mean) |
|---|
| UC-MSCs Group | 33.6 |
| Control Group | 34.64 |
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. (NCT04355728)
Timeframe: day 3 post first infusion
| Intervention | Participants (Count of Participants) |
|---|
| Class I72513536 | Class I72513537 | Class II72513536 | Class II72513537 |
|---|
| PRA Negative | PRA Positive |
|---|
| UC-MSCs Group | 10 |
| Control Group | 11 |
| UC-MSCs Group | 2 |
| Control Group | 0 |
| UC-MSCs Group | 4 |
| Control Group | 6 |
| UC-MSCs Group | 8 |
| Control Group | 5 |
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants. (NCT04355728)
Timeframe: day 6
| Intervention | Participants (Count of Participants) |
|---|
| Class I72513536 | Class I72513537 | Class II72513536 | Class II72513537 |
|---|
| PRA Positive | PRA Negative |
|---|
| UC-MSCs Group | 9 |
| Control Group | 9 |
| UC-MSCs Group | 1 |
| Control Group | 2 |
| UC-MSCs Group | 5 |
| Control Group | 5 |
| Control Group | 6 |
Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | U/L (Mean) |
|---|
| UC-MSCs Group | 55.8 |
| Control Group | 47 |
Blood Urea Nitrogen (BUN)
Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel. (NCT04355728)
Timeframe: day 6
| Intervention | mg/dL (Mean) |
|---|
| UC-MSCs Group | 48 |
| Control Group | 47.67 |
Glomerular Filtration Rate
Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute. (NCT04355728)
Timeframe: day 6
| Intervention | mL/min/1.73 m^2 (Mean) |
|---|
| UC-MSCs Group | 60.59 |
| Control Group | 68.67 |
C-Reactive Protein Levels
As assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | mg/L (Mean) |
|---|
| UC-MSCs Group | 101.01 |
| Control Group | 112.55 |
Oxygenation Index (OI)
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen). (NCT04355728)
Timeframe: day 6
| Intervention | Index (Mean) |
|---|
| UC-MSCs Group | 9.62 |
| Control Group | 12.74 |
Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90
Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician. (NCT04355728)
Timeframe: 90 days
| Intervention | percentage of participants (Number) |
|---|
| UC-MSCs Group | 41.67 |
| Control Group | 66.67 |
Platelets Count
As assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | 10^3 cells/uL (Mean) |
|---|
| UC-MSCs Group | 342 |
| Control Group | 397.89 |
Potassium
Potassium levels as assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | mmol/L (Mean) |
|---|
| UC-MSCs Group | 4.25 |
| Control Group | 4.37 |
Respiratory Rate and Oxygenation Index (ROX Index)
Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia. (NCT04355728)
Timeframe: day 6
| Intervention | Index (Mean) |
|---|
| UC-MSCs Group | 9.57 |
| Control Group | 7.44 |
Sequential Organ Failure Assessment (SOFA) Scores
Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure). (NCT04355728)
Timeframe: Day 6
| Intervention | score on a scale (Mean) |
|---|
| UC-MSCs Group | 6.56 |
| Control Group | 6.82 |
Hematocrit
The percentage by volume of red cells in your blood as assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | percentage of red blood cells by volume (Mean) |
|---|
| UC-MSCs Group | 37.98 |
| Control Group | 36.73 |
Glucose
Glucose levels as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | mg/dL (Mean) |
|---|
| UC-MSCs Group | 153.11 |
| Control Group | 183.89 |
D-dimer Levels
As assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | mcg/ml FEU (Mean) |
|---|
| UC-MSCs Group | 6.2 |
| Control Group | 4.69 |
Creatinine
Creatinine levels as assessed via serum blood samples (NCT04355728)
Timeframe: day 6
| Intervention | mg/dL (Mean) |
|---|
| UC-MSCs Group | 1.21 |
| Control Group | 1.24 |
Total Bilirubin
Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel. (NCT04355728)
Timeframe: day 6
| Intervention | mg/dL (Mean) |
|---|
| UC-MSCs Group | 0.88 |
| Control Group | 0.77 |
Chloride
Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel. (NCT04355728)
Timeframe: day 6
| Intervention | mmol/L (Mean) |
|---|
| UC-MSCs Group | 101.56 |
| Control Group | 102.44 |
Total Protein
Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins. (NCT04355728)
Timeframe: Day 6
| Intervention | g/dL (Mean) |
|---|
| UC-MSCs Group | 5.88 |
| Control Group | 5.8 |
Tumor Necrosis Factor-alpha (TNFα)
Analysis of TNFα in peripheral blood plasma (NCT04355728)
Timeframe: day 6
| Intervention | pg/mL (Median) |
|---|
| UC-MSCs Group | 349 |
| Control Group | 451 |
Tumor Necrosis Factor-beta (TNFβ)
Analysis of TNFβ in peripheral blood plasma (NCT04355728)
Timeframe: day 6
| Intervention | pg/mL (Median) |
|---|
| UC-MSCs Group | 829 |
| Control Group | 1540 |
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Number of days participants were off ventilators during 28 days post second infusion. (NCT04355728)
Timeframe: 28 days post second infusion
| Intervention | days (Median) |
|---|
| UC-MSCs Group | 28 |
| Control Group | 0 |
Ventilator-Free Days Throughout 90 Days
Number of days participants were off ventilators within up to 90 days of hospitalization. (NCT04355728)
Timeframe: 90 days or hospital discharge, whichever is earlier
| Intervention | days (Median) |
|---|
| UC-MSCs Group | 90 |
| Control Group | 0 |
Viral Load by SARS-CoV-2 RT-PCR
Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR). (NCT04355728)
Timeframe: day 6
| Intervention | RNA copies/mL (Median) |
|---|
| UC-MSCs Group | 0 |
| Control Group | 0 |
White Blood Cell Count (WBC)
As assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | 10^3 cells/uL (Mean) |
|---|
| UC-MSCs Group | 13.43 |
| Control Group | 15.53 |
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Total number of adverse events plus serious adverse events categorized by severity. (NCT04355728)
Timeframe: 90 days
| Intervention | Adverse Events (Number) |
|---|
| Mild | Moderate | Severe |
|---|
| Control Group | 13 | 21 | 19 |
,| UC-MSCs Group | 15 | 22 | 9 |
Number of Participants With Pre-Specified Infusion Associated Adverse Events
"Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:~An increase in vasopressor dose greater than or equal to the following:~Norepinephrine: 10 μg/min~Phenylephrine: 100 μg/min~Dopamine: 10 μg/kg/min~Epinephrine: 10 μg/min~In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of >20%.~In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.~New cardiac arrhythmia requiring cardioversion~New ventricular tachycardia, ventricular fibrillation, or asystole~A clinical scenario consistent with transfusion incompatibility or transfusion-related infection~Cardiac arrest or death within 24h post infusion" (NCT04355728)
Timeframe: 6 and 24 hours
| Intervention | Participants (Count of Participants) |
|---|
| Number of subjects with an increase in vasopressor dose at 6 h | In subjects receiving mechanical ventilation, Number of subjects with worsening of hypoxemia at 6 h | In subjects on high flow oxygen therapy:worsening hypoxemia(req intubat, mechanical ventilat) at 6 h | Number of subjects with new cardiac arrhythmia requiring cardioversion at 6 h | Number of subjects with new ventricular tachycardia, ventricular fibrillation, or asystole at 6 h | A clinical scenario consistent with transfusion incompatibility or transfusion-rel infection at 6h | Number of subjects with cardiac arrest or death within 24 h post infusion |
|---|
| Control Group | 1 | 1 | 0 | 1 | 1 | 0 | 0 |
,| UC-MSCs Group | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6) (NCT04355728)
Timeframe: day 6
| Intervention | cm H2O (Mean) |
|---|
| PEEP | Plateau Pressure |
|---|
| Control Group | 11.67 | 24 |
,| UC-MSCs Group | 9.73 | 28.67 |
Subjects With Adverse Events and Serious Adverse Events by Severity
Total number of subjects with adverse events and serious adverse events categorized by severity. (NCT04355728)
Timeframe: 90 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild | Moderate | Severe |
|---|
| Control Group | 5 | 8 | 7 |
,| UC-MSCs Group | 7 | 7 | 5 |
Hemogoblin
Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples. (NCT04355728)
Timeframe: day 6
| Intervention | g/dL (Mean) |
|---|
| UC-MSCs Group | 11.93 |
| Control Group | 11.94 |
Time to Recovery
Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered. (NCT04355728)
Timeframe: 31 days
| Intervention | days (Number) |
|---|
| Days by which 75% of subjects were recovered | Days by which 50% of subjects were recovered | Days by which 25% of subjects were recovered |
|---|
| Control Group | NA | NA | 12 |
,| UC-MSCs Group | 23 | 15 | 8 |
Number of Participants Who Are Alive and Free of Invasive Mechanical Ventilation or ECMO Through Day 28
The primary efficacy endpoint was to be the proportion of participants who were alive and free of invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) through Day 28. Data also shows proportion of participants with invasive mechanical ventilation or ECMO, all-cause mortality, or early study discontinuation (NCT04389840)
Timeframe: Day 1 to Day 28 (28 days)
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 Dociparstat | 3 |
| Cohort 1 Placebo | 4 |
| Cohort 2 Dociparstat | 7 |
| Cohort 2 Placebo | 3 |
| Cohort 3 Dociparstat | 2 |
| Cohort 3 Placebo | 1 |
Re-hospitalization
Need for Re-hospitalization will be based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 1 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 3 |
Major Bleeding
Risk of major bleeding defined using the International Society of Thrombosis and Haemostasis (ISTH) criteria (NCT04401293)
Timeframe: Day 30 ± 2 days
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 6 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 2 |
Progression to Acute Respiratory Distress Syndrome (ARDS)
Progression to Acute Respiratory Distress Syndrome (ARDS) based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 11 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 6 |
Sepsis-induced Coagulopathy (SIC) Score
"Sepsis-induced coagulopathy (SIC) score predicts likelihood of sepsis-induced coagulopathy based on ISTH guidelines.~The score uses the following domains:~Platelets, K/uL (thousands per microliter)~INR (International Normalized Ratio)~D-Dimer Level~Fibrinogen~Platelet count > 100 cells x 10^9/L is 0 points, platelet count 50 to 100 cells x 10^9/L is 1 point and Platelet count < 50 cells x 10^9/L is 2 points. INR < 1.3 is 0 points, INR 1.3 to 1.7 is 1 point and INR > 1.7 is 2 points. D-Dimer level < 400 ng/mL is 0 points, D-Dimer level 400-4000 ng/mL is 2 points and D-Dimer level > 4000 ng/mL is 3 points. Fibrinogen level > 100 mg/dL is 0 points and fibrinogen level < 100 mg/dL is 1 point.~Calculated (SIC) scores yields a possible 0 to 6 points, where ≥4 predicts higher mortality rates within 30 days and greater risk of pulmonary embolism." (NCT04401293)
Timeframe: Day 30 ± 2 days.
| Intervention | units on a scale (Mean) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 2.35 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 2.31 |
Need for Intubation
Need for Intubation will be based on monitoring of patient conditions. (NCT04401293)
Timeframe: Day 30 ± 2 days.
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 17 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 21 |
Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Day 30 ± 2 Days.
Risk of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Day 30 ± 2 days. (NCT04401293)
Timeframe: Day 30 ± 2 days
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 25 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 31 |
Composite Outcome of Arterial Thromboembolic Events, Venous Thromboembolic Events and All-cause Mortality at Hospital Day 10 + 4
The composite of arterial thromboembolic events (including myocardial infarction, stroke, systemic embolism), venous thromboembolism (including symptomatic deep vein thrombosis (DVT) of the upper or lower extremity, asymptomatic proximal DVT of the lower extremity, non-fatal pulmonary embolism (PE)), and all-cause mortality at Hospital Day 10 + 4 (NCT04401293)
Timeframe: Day 10 + 4
| Intervention | Participants (Count of Participants) |
|---|
| Full Dose LMWH Anticoagulation Therapy | 2 |
| Prophylactic/Intermediate Dose LMWH or UFH Therapy | 3 |
Number of Major and Clinically Relevant Non-major Bleeding Events
Comparison of major and clinically-relevant non-major bleeding events on each treatment arm, as defined by the International Society of Thrombosis and Haemostasis (ISTH) criteria. (NCT04406389)
Timeframe: 6 months
| Intervention | Count of Events (Number) |
|---|
| Major Bleeding Events | Clinically Relevant Non-Major Bleeding Events |
|---|
| Intermediate Dose Prophylaxis | 1 | 1 |
,| Therapeutic Dose Anticoagulation | 1 | 2 |
Number of Documented Venous Thromboembolism (VTE), Arterial Thrombosis (Stroke, Myocardial Infarction, Other) and Microthrombosis Events
Comparison of number of documented VTE, arterial thrombosis and microthrombosis events on each treatment arm (NCT04406389)
Timeframe: 6 months
| Intervention | Count of Events (Number) |
|---|
| Venous Thromboembolism Events | Arterial Thrombosis Events | Microthrombosis Events |
|---|
| Intermediate Dose Prophylaxis | 1 | 1 | 0 |
,| Therapeutic Dose Anticoagulation | 0 | 0 | 1 |
30-day Mortality
Comparison of number of COVID-19 positive patients who have died within 30 days of starting treatment on each treatment arm (NCT04406389)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Intermediate Dose Prophylaxis | 0 |
| Therapeutic Dose Anticoagulation | 2 |
Length of Intensive Care Unit (ICU) Stay in Days
Comparison of length of ICU stay in days between each treatment arm. (NCT04406389)
Timeframe: 6 months
| Intervention | Days (Median) |
|---|
| Intermediate Dose Prophylaxis | 25.5 |
| Therapeutic Dose Anticoagulation | 25 |
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | hour * nanogram / milliliter (h*ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 369.21 |
| Part B: Alteplase, TPA-05 | 377.35 |
Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Maximum measured concentration of Alteplase in plasma (Cmax) is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | nanogram / milliliter (ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 738.35 |
| Part B: Alteplase, TPA-05 | 781.24 |
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of alteplase in plasma over the interval from 0 extrapolated to infinity is reported. (NCT04419493)
Timeframe: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
| Intervention | hour*nanogram/milliliter (h*ng/mL) (Geometric Least Squares Mean) |
|---|
| Part B: Alteplase, TPA -02 | 371.85 |
| Part B: Alteplase, TPA-05 | 379.90 |
Change in Fasting Glucagon in the Presence or Absence of Exendin-9,39
"Concentrations of glucagon Measured by immunoassay over the -30 to 0 minutes of study.~On one study day subjects received saline, on the other exendin-9,39. The infusion commenced at -120 minutes." (NCT04466618)
Timeframe: Average concentration over the -30 to 0 minutes of study
| Intervention | pmol/l (Mean) |
|---|
| Saline | Exendin 9-39 |
|---|
| No Diabetes | 7.4 | 7.8 |
,| Type 2 Diabetes | 7.9 | 10.2 |
Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14
Abnormally low platelet counts indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase. (NCT04490239)
Timeframe: Day 14, Chronic Phase
| Intervention | Participants (Count of Participants) |
|---|
| Participants with normal platelet counts (150,000 - 450,000 platelets/uL) | Participants with abnormal platelet counts (<150,000 or >450,000 platelets/uL) |
|---|
| Experimental Arm | 6 | 0 |
Number of Incidents of Epistaxis, Acute Phase
Number of incidents of blood coming from the nose during the acute phase (NCT04490239)
Timeframe: Day 0 through Day 2, acute phase
| Intervention | Reported incidents (Number) |
|---|
| Experimental Arm | 0 |
Number of Incidents of Epistaxis, Chronic Phase
Blood coming from the nose or pink tinged nasal secretions (NCT04490239)
Timeframe: Day 1 through Day 15, chronic phase
| Intervention | Reported incidents (Number) |
|---|
| Experimental Arm | 1 |
Other Adverse Effects, Acute Phase
Reports of mild, short-lived nasal irritation immediately after administration including mild burning sensation (NCT04490239)
Timeframe: Day 0 through Day 2, acute phase
| Intervention | Reported incidents (Number) |
|---|
| Experimental Arm | 2 |
Other Adverse Effects, Chronic Phase
Reports of mild, short-lived nasal irritation immediately after administration including mild burning sensation, itchiness or sneezing (NCT04490239)
Timeframe: Day 1 through Day 15, chronic phase
| Intervention | Reported incidents (Number) |
|---|
| Experimental Arm | 5 |
Percent Change in Platelet Count From Pre-dose Baseline
Indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase. (NCT04490239)
Timeframe: Pre-dose baseline, Day 14 chronic phase
| Intervention | percent change from baseline (Mean) |
|---|
| Experimental Arm | 2.2 |
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 2000 U intranasal dose of heparin (NCT04490239)
Timeframe: 24 hours after 2000 U dose intranasal heparin
| Intervention | Participants (Count of Participants) |
|---|
| Participants with normal aPTT (24-33 sec) | Participants with abnormal aPTT (<24 sec or >33 sec) |
|---|
| Experimental Arm | 6 | 0 |
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained immediately after the 14 consecutive day of daily 2000 U dose of intranasal heparin (NCT04490239)
Timeframe: Day 14, chronic phase
| Intervention | Participants (Count of Participants) |
|---|
| Participants with normal aPTT (24-33 sec) | Participants with abnormal aPTT (<24 sec or >33 sec) |
|---|
| Experimental Arm | 6 | 0 |
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained 24 hours after the 14 consecutive day of daily 2000 U dose of intranasal heparin (NCT04490239)
Timeframe: 24 hours after the last 2000 U dose of the chronic phase
| Intervention | Participants (Count of Participants) |
|---|
| Participants with normal aPTT (24-33 sec) | Participants with abnormal aPTT (<24 sec or >33 sec) |
|---|
| Experimental Arm | 6 | 0 |
Maximum Anti-Factor Xa Level Measured
(NCT04635839)
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
| Intervention | IU/mL (Median) |
|---|
| Standard Dosing | 0.09 |
| Gestational Age-Based Dosing | 0.09 |
Number of Participants Diagnosed With Venous Thromboembolism (Pulmonary Embolism and/or Deep Venous Thromboembolism)
(NCT04635839)
Timeframe: Assessed throughout hospitalization, an average length of 8 days, until 6 weeks after delivery
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 1 |
| Gestational Age-Based Dosing | 0 |
Number of Participants That Had a Delay in Timing of Delivery Due to Unfractionated Heparin
(NCT04635839)
Timeframe: Assessed at time of delivery
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 0 |
| Gestational Age-Based Dosing | 0 |
Number of Participants That Received a Blood Transfusion
(NCT04635839)
Timeframe: From time of delivery until 6 weeks after delivery
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 1 |
| Gestational Age-Based Dosing | 7 |
Number of Participants That Received General Anesthesia
(NCT04635839)
Timeframe: Assessed at time of delivery
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 1 |
| Gestational Age-Based Dosing | 0 |
Number of Participants Who Did Not Receive or Had a Delay of Neuraxial Anesthesia Due to Unfractionated Heparin
(NCT04635839)
Timeframe: Assessed at time of delivery
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 0 |
| Gestational Age-Based Dosing | 0 |
Maximum Activated Partial Thromboplastin Clotting Time Levels Measured
(NCT04635839)
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
| Intervention | seconds (Median) |
|---|
| Standard Dosing | 26.6 |
| Gestational Age-Based Dosing | 30.4 |
Number of Participants With Elevated Serum Activated Partial Thromboplastin Time Above the Normal Range (> 36.2 Seconds).
Surrogate marker for whether or not the patient would be eligible for neuraxial anesthesia based on guidelines for neuraxial anesthesia in pregnant women receiving VTE prophylaxis (NCT04635839)
Timeframe: Collected 6 hours after unfractionated heparin dose until patient was taken of unfractionated heparin, an average of 1 week
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dosing | 1 |
| Gestational Age-Based Dosing | 8 |
Mode of Delivery
(NCT04635839)
Timeframe: Assessed at time of delivery
| Intervention | Participants (Count of Participants) |
|---|
| Vaginal delivery | Cesarean delivery |
|---|
| Gestational Age-Based Dosing | 4 | 20 |
,| Standard Dosing | 6 | 14 |
Estimated Blood Loss From Delivery
(NCT04635839)
Timeframe: Assessed at time of delivery
| Intervention | cc (Median) |
|---|
| Standard Dosing | 654 |
| Gestational Age-Based Dosing | 593 |
Change in Antiphospholipid Antibodies Laboratory Values From Baseline Through Day 8 (Anti-Beta 2 Glycoprotein IgG) (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline. (NCT04655586)
Timeframe: 8 days
| Intervention | percentage change (Mean) |
|---|
| rNAPc2 Lower Dose | -24.04 |
| rNAPc2 Higher Dose | -274.3 |
| Heparin | 62.99 |
Change in High Sensitivity C-reactive Protein Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline. (NCT04655586)
Timeframe: 8 days
| Intervention | percent change (Mean) |
|---|
| rNAPc2 Lower Dose | -26.1 |
| rNAPc2 Higher Dose | 270.9 |
| Heparin | 12.8 |
Change in Interleukin-6 Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline. (NCT04655586)
Timeframe: 8 days
| Intervention | percentage change (Mean) |
|---|
| rNAPc2 Lower Dose | 317.4 |
| rNAPc2 Higher Dose | 768.1 |
| Heparin | 8.4 |
Change in Tissue Factor Laboratory Values From Baseline Through Day 8 (Phase 2b)
Central lab samples collected per protocol. Proportional change is represented as percent change, and is defined as: 100 × (Biomarker level at Day 8 or early discharge - Biomarker level at baseline)/Biomarker level at baseline. (NCT04655586)
Timeframe: 8 days
| Intervention | percentage change (Mean) |
|---|
| rNAPc2 Lower Dose | -21.2 |
| rNAPc2 Higher Dose | -1.8 |
| Heparin | 23.3 |
Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available. (NCT04655586)
Timeframe: 8 days
| Intervention | Percent change (Mean) |
|---|
| rNAPc2 Lower Dose | 137 |
| rNAPc2 Higher Dose | 41.4 |
| Heparin | 34.7 |
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b)
Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized. (NCT04655586)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| ISTH Major or Non-Major Clinically Relevant | ISTH Major | ISTH Non-major Clinically Relevant | ISTH Not Clinically Relevant | Subjects With Any ISTH if Major | TIMI Major | TIMI Minor | TIMI medical attention | TIMI Minimal |
|---|
| Heparin | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
,| rNAPc2 Higher Dose | 1 | 1 | 0 | 1 | 2 | 0 | 1 | 0 | 1 |
,| rNAPc2 Lower Dose | 1 | 0 | 1 | 2 | 3 | 0 | 0 | 1 | 2 |
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b)
Clinical events as reported by site. ISTH= International Society on Thrombosis and Haemostasis, TIMI= Thrombolysis in Myocardial Infarction. Heparin Dosing Strategy as indicated by Investigator. Where subjects have more than one bleeding event recorded, only the highest level of severity was summarized. (NCT04655586)
Timeframe: 8 days
| Intervention | Participants (Count of Participants) |
|---|
| ISTH Major or Non-Major Clinically Relevant | Subjects with any ISTH if Major | TIMI Major | TIMI Minor | TIMI Medical attention | TIMI Minimal |
|---|
| Heparin | 1 | 1 | 1 | 0 | 0 | 0 |
,| rNAPc2 Higher Dose | 0 | 0 | 0 | 0 | 0 | 0 |
,| rNAPc2 Lower Dose | 0 | 1 | 0 | 0 | 0 | 1 |
Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b)
Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 2/3 or early discharge - D-Dimer level at baseline)/D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory. (NCT04655586)
Timeframe: 2 days and 3 days
| Intervention | percentage change (Mean) |
|---|
| Day 2 (24h post D1 dose) | Day 3 (48h post D1 dose) |
|---|
| Heparin | 43.5 | 21.5 |
,| rNAPc2 Higher Dose | -0.1 | -2.3 |
,| rNAPc2 Lower Dose | 23.9 | 65.8 |
Mean PaO2/FiO2 Ratio
(NCT04842292)
Timeframe: Within the first 10 days of ICU stay or up until ICU discharge, whichever occurs first
| Intervention | units on a scale (Mean) |
|---|
| Participants | NA |
Incidence of Venous Thromboembolism
(NCT04842292)
Timeframe: Up to discharge or 3 months following enrollment, whichever occurs first
| Intervention | Incidence (Number) |
|---|
| Participants | NA |
Clinically Significant Bleeding
(NCT04842292)
Timeframe: Up to discharge or 3 months following enrollment, whichever occurs first
| Intervention | units on a scale (Mean) |
|---|
| Participants | NA |