dalteparin has been researched along with Intracranial Hemorrhages in 29 studies
Dalteparin: A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed)
Intracranial Hemorrhages: Bleeding within the SKULL, including hemorrhages in the brain and the three membranes of MENINGES. The escape of blood often leads to the formation of HEMATOMA in the cranial epidural, subdural, and subarachnoid spaces.
| Excerpt | Relevance | Reference |
|---|---|---|
| "We sought explore the relative benefits of unfractionated heparin (UFH) compared with enoxaparin, alone or in combination with clopidogrel, in ST-segment elevation myocardial infarction (STEMI) patients not undergoing reperfusion therapy." | 7.81 | Unfractionated heparin-clopidogrel combination in ST-elevation myocardial infarction not receiving reperfusion therapy. ( Badimon, L; Bugiardini, R; Calmac, L; Cenko, E; Daullxhiu, I; Dorobantu, M; Kedev, S; Knežević, B; Koller, A; Manfrini, O; Miličić, D; Puddu, PE; Ricci, B; Trninic, D; Vasiljevic, Z, 2015) |
| "Among hospitalized medically ill patients, extended-duration betrixaban demonstrated an ≈30% reduction in fatal or irreversible ischemic or bleeding events compared with standard-duration enoxaparin." | 5.24 | Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. ( Arbetter, D; Chi, G; Cohen, AT; Daaboul, Y; Gibson, CM; Gold, A; Goldhaber, SZ; Harrington, RA; Hernandez, AF; Hull, R; Jain, P; Korjian, S; Lopes, RD, 2017) |
| "We sought explore the relative benefits of unfractionated heparin (UFH) compared with enoxaparin, alone or in combination with clopidogrel, in ST-segment elevation myocardial infarction (STEMI) patients not undergoing reperfusion therapy." | 3.81 | Unfractionated heparin-clopidogrel combination in ST-elevation myocardial infarction not receiving reperfusion therapy. ( Badimon, L; Bugiardini, R; Calmac, L; Cenko, E; Daullxhiu, I; Dorobantu, M; Kedev, S; Knežević, B; Koller, A; Manfrini, O; Miličić, D; Puddu, PE; Ricci, B; Trninic, D; Vasiljevic, Z, 2015) |
| "Bleeding was predominantly gastrointestinal or intracranial." | 2.82 | Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors. ( Albaladejo, P; Beyer-Westendorf, J; Bronson, MD; Cohen, AT; Conley, PB; Connolly, SJ; Crowther, M; Curnutte, JT; Eikelboom, JW; Gibson, CM; Gold, A; Goodman, S; Leeds, J; Lim, WT; Lopez-Sendon, J; Lu, G; Meeks, B; Middeldorp, S; Milling, TJ; Nakamya, J; Schmidt, J; Siegal, DM; Verhamme, P; Wiens, BL; Zotova, E, 2016) |
| " The authors hypothesize that early chemoprophylaxis in patients with TBI is safe and efficacious." | 2.78 | Safety and efficacy of early thromboembolism chemoprophylaxis after intracranial hemorrhage from traumatic brain injury. ( Barnes, SL; Farooqui, A; Hiser, B; Litofsky, NS, 2013) |
| " The goal of this study was to determine whether enoxaparin for early venous thromboembolism (VTE) prophylaxis is safe for hemodynamically stable patients with TBIs." | 2.76 | Is early venous thromboembolism prophylaxis safe in trauma patients with intracranial hemorrhage. ( Davidson, MA; Guillamondegui, O; Koehler, DM; Shipman, J, 2011) |
| "No significant increase in major intracranial hemorrhage (p = 0." | 2.58 | Chemical venous thromboembolism prophylaxis in neurosurgical patients: an updated systematic review and meta-analysis. ( Khan, NR; Lee, SL; Patel, PG; Sharpe, JP; Sorenson, J, 2018) |
| "Multiple studies have addressed deep vein thrombosis chemoprophylaxis timing in traumatic brain injuries." | 2.52 | Timing for deep vein thrombosis chemoprophylaxis in traumatic brain injury: an evidence-based review. ( Abdel-Aziz, H; Dunham, CM; Hileman, BM; Malik, RJ, 2015) |
| "The incidence of pulmonary embolism (2." | 1.91 | Early venous thromboembolism prophylaxis in patients with trauma intracranial hemorrhage: Analysis of the prospective multicenter Consortium of Leaders in Traumatic Thromboembolism study. ( Chien, CY; Inaba, K; Knudson, MM; Martin, MJ; Matsushima, K; Moore, EE; Sauaia, A; Schellenberg, M; Wu, YT, 2023) |
| " Current literature suggests weight-based dosing is superior to standard dosing for adequate chemoprophylaxis." | 1.72 | Effective use of weight-based enoxaparin for deep vein thrombosis chemoprophylaxis in patients with traumatic brain injury. ( Huang, E; Martinez-Quinones, P; Robinson, T; Taylor, A; White, CQ, 2022) |
| "However, risk of increased intracranial hemorrhage in traumatic brain injury (TBI) population is of concern." | 1.48 | The impact of enoxaparin administration in relationship to hemorrhage in mild traumatic brain injury. ( Becker, G; Dhir, T; Kaplan, M; Kriza, C; Leung, P; McGreen, B; Minimo, C; Patel, N; Randhawa, S; Samuel, S; Weiss, E; Wolanin, K, 2018) |
| "Spontaneous intracranial hemorrhage (ICH) is also a frequent occurrence in these patients, but there is limited data on the safety of therapeutic anticoagulation." | 1.46 | Predicting the higher rate of intracranial hemorrhage in glioma patients receiving therapeutic enoxaparin. ( Mantia, C; Neuberg, D; Puligandla, M; Uhlmann, EJ; Weber, GM; Zwicker, JI, 2017) |
| "Delayed catheter-related intracranial hemorrhage is not rare after a ventriculoperitoneal (VP) or ventriculoatrial (VA) shunt for the treatment of hydrocephalus." | 1.46 | Delayed Catheter-Related Intracranial Hemorrhage After a Ventriculoperitoneal or Ventriculoatrial Shunt in Hydrocephalus. ( Gao, L; Pandey, S; Qian, Z; Wang, K, 2017) |
| "Aspirin (53." | 1.43 | Antithrombotic Medication Use and Misuse Among Patients with Intracranial Hemorrhage: A 16-Year, Lebanese, Single-Center Experience. ( Fahed, E; Ghauche, J; Maarrawi, J; Menassa-Moussa, L; Moussa, R; Nohra, G; Okais, N; Rahme, R; Rizk, T; Samaha, E, 2016) |
| "To assess the risk for intracranial hemorrhage associated with the administration of therapeutic doses of low-molecular-weight heparin, we performed a matched, retrospective cohort study of 293 patients with cancer with brain metastases (104 with therapeutic enoxaparin and 189 controls)." | 1.42 | Intracranial hemorrhage in patients with brain metastases treated with therapeutic enoxaparin: a matched cohort study. ( Campigotto, F; Coletti, E; Donato, J; Neuberg, D; Uhlmann, EJ; Weber, GM; Zwicker, JI, 2015) |
| "A patient with a history of intracranial hemorrhage who was hospitalized due to massive pulmonary thromboembolism (PTE) was presented." | 1.39 | [Intracranial hemorrhage due to pulmonary thromboembolism in heparin therapy and therapeutic management of patients hospitalized with massive pulmonary embolism after discharge]. ( Alişir, MF; Beşli, F; Güngören, F; Keçebaş, M, 2013) |
| "Patients with brain tumors including intracranial meningiomas are at increased risk for developing deep vein thrombosis (DVTs) and suffering thromboembolic events (VTEs)." | 1.35 | Adjuvant enoxaparin therapy may decrease the incidence of postoperative thrombotic events though does not increase the incidence of postoperative intracranial hemorrhage in patients with meningiomas. ( Berger, MS; Cage, TA; Chakalian, L; Frankfurt, A; Lamborn, KR; McDermott, MW; Ware, ML, 2009) |
| "Incidence, seriousness and causality of maternal, fetal and neonatal adverse events, pregnancy outcome, and incidence of venous thromboembolism." | 1.31 | Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies. ( Borel-Derlon, A; Borg, JY; Boudignat, O; Cohen, C; Conard, J; Darmon, JY; Francoual, C; Lepercq, J; Priollet, P; Schved, JF; Tournaire, M; Yvelin, N, 2001) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 10 (34.48) | 29.6817 |
| 2010's | 17 (58.62) | 24.3611 |
| 2020's | 2 (6.90) | 2.80 |
| Authors | Studies |
|---|---|
| Beşli, F | 1 |
| Keçebaş, M | 1 |
| Alişir, MF | 1 |
| Güngören, F | 1 |
| Wu, YT | 1 |
| Chien, CY | 1 |
| Matsushima, K | 1 |
| Schellenberg, M | 1 |
| Inaba, K | 1 |
| Moore, EE | 1 |
| Sauaia, A | 1 |
| Knudson, MM | 1 |
| Martin, MJ | 1 |
| Taylor, A | 1 |
| Martinez-Quinones, P | 1 |
| Huang, E | 1 |
| Robinson, T | 1 |
| White, CQ | 1 |
| Mantia, C | 1 |
| Uhlmann, EJ | 2 |
| Puligandla, M | 1 |
| Weber, GM | 2 |
| Neuberg, D | 2 |
| Zwicker, JI | 2 |
| Gibson, CM | 3 |
| Korjian, S | 1 |
| Chi, G | 1 |
| Daaboul, Y | 1 |
| Jain, P | 1 |
| Arbetter, D | 1 |
| Goldhaber, SZ | 1 |
| Hull, R | 1 |
| Hernandez, AF | 1 |
| Lopes, RD | 1 |
| Gold, A | 2 |
| Cohen, AT | 2 |
| Harrington, RA | 2 |
| Qian, Z | 1 |
| Gao, L | 1 |
| Wang, K | 1 |
| Pandey, S | 1 |
| Khan, NR | 1 |
| Patel, PG | 1 |
| Sharpe, JP | 1 |
| Lee, SL | 1 |
| Sorenson, J | 1 |
| Dhir, T | 1 |
| Weiss, E | 1 |
| Wolanin, K | 1 |
| Randhawa, S | 1 |
| Samuel, S | 1 |
| Minimo, C | 1 |
| Becker, G | 1 |
| McGreen, B | 1 |
| Kriza, C | 1 |
| Patel, N | 1 |
| Kaplan, M | 1 |
| Leung, P | 1 |
| Armstrong, PW | 2 |
| Gershlick, AH | 1 |
| Goldstein, P | 2 |
| Wilcox, R | 1 |
| Danays, T | 2 |
| Lambert, Y | 1 |
| Sulimov, V | 1 |
| Rosell Ortiz, F | 1 |
| Ostojic, M | 1 |
| Welsh, RC | 1 |
| Carvalho, AC | 1 |
| Nanas, J | 1 |
| Arntz, HR | 1 |
| Halvorsen, S | 1 |
| Huber, K | 1 |
| Grajek, S | 1 |
| Fresco, C | 1 |
| Bluhmki, E | 1 |
| Regelin, A | 1 |
| Vandenberghe, K | 1 |
| Bogaerts, K | 2 |
| Van de Werf, F | 2 |
| Farooqui, A | 1 |
| Hiser, B | 1 |
| Barnes, SL | 1 |
| Litofsky, NS | 1 |
| Abdel-Aziz, H | 1 |
| Dunham, CM | 1 |
| Malik, RJ | 1 |
| Hileman, BM | 1 |
| Donato, J | 1 |
| Campigotto, F | 1 |
| Coletti, E | 1 |
| Bugiardini, R | 1 |
| Dorobantu, M | 1 |
| Vasiljevic, Z | 1 |
| Kedev, S | 1 |
| Knežević, B | 1 |
| Miličić, D | 1 |
| Calmac, L | 1 |
| Trninic, D | 1 |
| Daullxhiu, I | 1 |
| Cenko, E | 1 |
| Ricci, B | 1 |
| Puddu, PE | 1 |
| Manfrini, O | 1 |
| Koller, A | 1 |
| Badimon, L | 1 |
| Kreuziger, LB | 1 |
| Fahed, E | 1 |
| Ghauche, J | 1 |
| Rahme, R | 1 |
| Okais, N | 1 |
| Samaha, E | 1 |
| Nohra, G | 1 |
| Rizk, T | 1 |
| Maarrawi, J | 1 |
| Menassa-Moussa, L | 1 |
| Moussa, R | 1 |
| Connolly, SJ | 1 |
| Milling, TJ | 1 |
| Eikelboom, JW | 2 |
| Curnutte, JT | 1 |
| Bronson, MD | 1 |
| Lu, G | 1 |
| Conley, PB | 1 |
| Verhamme, P | 1 |
| Schmidt, J | 1 |
| Middeldorp, S | 1 |
| Beyer-Westendorf, J | 1 |
| Albaladejo, P | 1 |
| Lopez-Sendon, J | 1 |
| Goodman, S | 1 |
| Leeds, J | 1 |
| Wiens, BL | 1 |
| Siegal, DM | 1 |
| Zotova, E | 1 |
| Meeks, B | 1 |
| Nakamya, J | 1 |
| Lim, WT | 1 |
| Crowther, M | 1 |
| Cage, TA | 1 |
| Lamborn, KR | 1 |
| Ware, ML | 1 |
| Frankfurt, A | 1 |
| Chakalian, L | 1 |
| Berger, MS | 1 |
| McDermott, MW | 1 |
| Giugliano, RP | 1 |
| Giraldez, RR | 1 |
| Morrow, DA | 2 |
| Antman, EM | 2 |
| Mohanavelu, S | 1 |
| Murphy, SA | 2 |
| McCabe, CH | 2 |
| Braunwald, E | 2 |
| Koehler, DM | 1 |
| Shipman, J | 1 |
| Davidson, MA | 1 |
| Guillamondegui, O | 1 |
| Phelan, HA | 1 |
| Wolf, SE | 1 |
| Norwood, SH | 1 |
| Aldy, K | 1 |
| Brakenridge, SC | 1 |
| Eastman, AL | 1 |
| Madden, CJ | 1 |
| Nakonezny, PA | 1 |
| Yang, L | 1 |
| Chason, DP | 1 |
| Arbique, GM | 1 |
| Berne, J | 1 |
| Minei, JP | 1 |
| Ruda, M | 1 |
| Sadowski, Z | 1 |
| Budaj, A | 1 |
| López-Sendón, JL | 1 |
| Guneri, S | 1 |
| Jiang, F | 1 |
| White, HD | 1 |
| Fox, KA | 1 |
| Chang, WC | 1 |
| Wallentin, L | 1 |
| Granger, CB | 1 |
| Alexander, JH | 1 |
| Ross, AM | 1 |
| Molhoek, P | 1 |
| Lundergan, C | 1 |
| Knudtson, M | 1 |
| Draoui, Y | 1 |
| Regalado, L | 1 |
| Le Louer, V | 1 |
| Bigonzi, F | 1 |
| Schwartz, W | 1 |
| de Jong, E | 1 |
| Coyne, K | 1 |
| Bagga, R | 1 |
| Sawhney, H | 1 |
| Saxena, SV | 1 |
| Aggarwal, N | 1 |
| Vasishta, K | 1 |
| Lepercq, J | 1 |
| Conard, J | 1 |
| Borel-Derlon, A | 1 |
| Darmon, JY | 1 |
| Boudignat, O | 1 |
| Francoual, C | 1 |
| Priollet, P | 1 |
| Cohen, C | 1 |
| Yvelin, N | 1 |
| Schved, JF | 1 |
| Tournaire, M | 1 |
| Borg, JY | 1 |
| Kleindienst, A | 1 |
| Harvey, HB | 1 |
| Mater, E | 1 |
| Bronst, J | 1 |
| Flack, J | 1 |
| Herenz, K | 1 |
| Haupt, WF | 1 |
| Schön, R | 1 |
| Macdonald, RL | 1 |
| Amidei, C | 1 |
| Baron, J | 1 |
| Weir, B | 1 |
| Brown, F | 1 |
| Erickson, RK | 1 |
| Hekmatpanah, J | 1 |
| Frim, D | 1 |
| Yusuf, S | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| (Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients[NCT01583218] | Phase 3 | 7,513 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
| STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within[NCT00623623] | Phase 3 | 1,899 participants (Actual) | Interventional | 2008-03-01 | Completed | ||
| STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction[NCT02777580] | Phase 4 | 609 participants (Actual) | Interventional | 2017-08-01 | Active, not recruiting | ||
| Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial[NCT04717986] | 188 participants (Actual) | Interventional | 2021-01-26 | Completed | |||
| Reperfusion Strategies in ST Elevation Myocardial Infarction Network - Sao Paulo Registry.[NCT02090712] | 3,000 participants (Anticipated) | Observational [Patient Registry] | 2010-01-31 | Enrolling by invitation | |||
| International Survey of Acute Coronary Syndromes in Transitional Countries[NCT01218776] | 36,000 participants (Anticipated) | Observational | 2010-09-28 | Recruiting | |||
| Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation[NCT03021928] | Phase 3 | 200 participants (Actual) | Interventional | 2017-06-14 | Active, not recruiting | ||
| Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)[NCT02329327] | Phase 3 | 479 participants (Actual) | Interventional | 2015-04-10 | Completed | ||
| Phase 1 Study in Humans Evaluating the Safety of Rectus Sheath Implantation of Diffusion Chambers Encapsulating Autologous Malignant Glioma Cells Treated With Insulin-Like Growth Factor Receptor-1 Antisense Oligodeoxynucleotide in 12 Patients With Recurre[NCT01550523] | Phase 1 | 13 participants (Actual) | Interventional | 2012-02-09 | Completed | ||
| A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolyt[NCT00077792] | Phase 3 | 20,506 participants (Actual) | Interventional | 2002-10-31 | Completed | ||
| Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses[NCT01828697] | Phase 4 | 1,110 participants (Actual) | Interventional | 2013-04-24 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 1: Between randomization and Day 42 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 1.30 |
| Enoxaparin | 1.90 |
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 2: Between randomization and Day 42 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 1.03 |
| Enoxaparin | 1.45 |
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 2: Between randomization and Day 47 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 4.70 |
| Enoxaparin | 6.02 |
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT: Between randomization and Day 42 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 0.94 |
| Enoxaparin | 1.45 |
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT: Between randomization and Day 47 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 4.43 |
| Enoxaparin | 5.99 |
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 1: Between randomization and Day 47 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 5.70 |
| Enoxaparin | 7.18 |
Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication. (NCT01583218)
Timeframe: Between randomization and Day 49 (max)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Betrixaban | 0.67 |
| Enoxaparin | 0.57 |
This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 50 |
| Primary PCI (Group B) | 43 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 59 |
| Primary PCI (Group B) | 73 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 100 |
| Primary PCI (Group B) | 123 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 117 |
| Primary PCI (Group B) | 135 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 77 |
| Primary PCI (Group B) | 85 |
This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 43 |
| Primary PCI (Group B) | 42 |
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS). (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 116 |
| Primary PCI (Group B) | 135 |
This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 31 |
| Primary PCI (Group B) | 32 |
This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 41 |
| Primary PCI (Group B) | 56 |
This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 57 |
| Primary PCI (Group B) | 72 |
This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 9 |
| Primary PCI (Group B) | 2 |
This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 6 |
| Primary PCI (Group B) | 3 |
This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 61 |
| Primary PCI (Group B) | 45 |
This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 206 |
| Primary PCI (Group B) | 191 |
This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 23 |
| Primary PCI (Group B) | 21 |
This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 45 |
| Primary PCI (Group B) | 41 |
This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 19 |
| Primary PCI (Group B) | 11 |
This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 1 |
| Primary PCI (Group B) | 2 |
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 32 |
| Primary PCI (Group B) | 38 |
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 10 |
| Primary PCI (Group B) | 29 |
This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 2 |
| Primary PCI (Group B) | 0 |
This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 7 |
| Primary PCI (Group B) | 4 |
This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 8 |
| Primary PCI (Group B) | 1 |
This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 267 |
| Primary PCI (Group B) | 236 |
This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported (NCT00623623)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|---|
| Tenecteplase (Group A) | 15 |
| Primary PCI (Group B) | 5 |
Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. The change from baseline was calculated as the reduction in anti-fXa activity from baseline to the on-treatment nadir (that is, the minimum value between end of bolus and end of infusion). Percent reduction was calculated as the ratio between the maximum change from baseline and the baseline value, multiplied by 100. (NCT02329327)
Timeframe: Baseline, 12 Hours (post infusion)
| Intervention | Percent Change (Median) |
|---|---|
| FXa Inhibitor: Apixaban | -93.3 |
| FXa Inhibitor: Rivaroxaban | -94.1 |
| FXa Inhibitor: Edoxaban | -71.3 |
| FXa Inhibitor: Enoxaparin | -75.41 |
| FXa Inhibitor: Rivaroxaban - Additional Participants | -96.3 |
Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons. These ratings were based on pre-specified criteria that were included in the EAC Charter. The EAC was blinded to anti-fXa activity levels. Participant results were classified as either success or failure based on the hemostatic efficacy rating (success = excellent/good, failure = poor/none). Participants rated by the EAC as non-evaluable due to administrative reasons were excluded from the analysis of hemostatic efficacy. (NCT02329327)
Timeframe: 12 Hours (post infusion)
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| Excellent/Good | Poor/None | |
| Andexanet: High Dose | 54 | 17 |
| Andexanet: High Dose - Additional Participant | 1 | 0 |
| Andexanet: Low Dose | 218 | 51 |
| Andexanet: Low Dose - Additional Participant | 1 | 0 |
| Bleed Type: Gastrointestinal | 61 | 13 |
| Bleed Type: Intracranial Hemorrhage | 193 | 51 |
| Bleed Type: Intracranial Hemorrhage - Additional Participants | 2 | 0 |
| Bleed Type: Other | 18 | 4 |
| FXa Inhibitor: Apixaban | 134 | 35 |
| FXa Inhibitor: Edoxaban | 22 | 6 |
| FXa Inhibitor: Enoxaparin | 14 | 2 |
| FXa Inhibitor: Rivaroxaban | 102 | 25 |
| FXa Inhibitor: Rivaroxaban - Additional Participants | 2 | 0 |
| Overall | 272 | 68 |
This outcome measure assessed the relationship between hemostatic efficacy and anti-fXa activity in participants receiving an FXa inhibitor who had acute major bleeding. Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons. (NCT02329327)
Timeframe: Baseline, 12 Hours (post infusion)
| Intervention | Percent Change (Median) |
|---|---|
| Excellent/Good | |
| FXa Inhibitor: Rivaroxaban - Additional Participants | -96.3 |
This outcome measure assessed the relationship between hemostatic efficacy and anti-fXa activity in participants receiving an FXa inhibitor who had acute major bleeding. Anti-fXa activity was measured to assess the ability of andexanet to reverse the anticoagulant effect of FXa inhibitors. Baseline was defined as the last value obtained prior to the start of the andexanet bolus. Hemostatic efficacy was achieved when the body had time to produce thrombin and a subsequent clot and was rated by the EAC as: excellent; good; poor/none; not evaluable due to non-administrative reasons; not evaluable due to administrative reasons. (NCT02329327)
Timeframe: Baseline, 12 Hours (post infusion)
| Intervention | Percent Change (Median) | |
|---|---|---|
| Excellent/Good | Poor/None | |
| FXa Inhibitor: Apixaban | -93.4 | -93.3 |
| FXa Inhibitor: Edoxaban | -75.8 | -65.2 |
| FXa Inhibitor: Enoxaparin | -75.20 | -78.44 |
| FXa Inhibitor: Rivaroxaban | -94.6 | -92.4 |
3 reviews available for dalteparin and Intracranial Hemorrhages
| Article | Year |
|---|---|
Chemical venous thromboembolism prophylaxis in neurosurgical patients: an updated systematic review and meta-analysis.
Topics: Anticoagulants; Enoxaparin; Evidence-Based Medicine; Hemorrhage; Heparin, Low-Molecular-Weight; Intr | 2018 |
Timing for deep vein thrombosis chemoprophylaxis in traumatic brain injury: an evidence-based review.
Topics: Anticoagulants; Brain Injuries; Enoxaparin; Humans; Intracranial Hemorrhages; Risk Factors; Venous T | 2015 |
Efficacy and safety of unfractionated heparin versus enoxaparin: a pooled analysis of ASSENT-3 and -3 PLUS data.
Topics: Area Under Curve; Drug Therapy, Combination; Emergency Treatment; Enoxaparin; Fibrinolytic Agents; H | 2006 |
10 trials available for dalteparin and Intracranial Hemorrhages
| Article | Year |
|---|---|
Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy.
Topics: Acute Disease; Adult; Aged; Anticoagulants; Benzamides; Cardiovascular Diseases; Double-Blind Method | 2017 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Safety and efficacy of early thromboembolism chemoprophylaxis after intracranial hemorrhage from traumatic brain injury.
Topics: Adult; Aged; Anticoagulants; Brain Injuries; Chemoprevention; Clinical Protocols; Cohort Studies; En | 2013 |
Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.
Topics: Acute Disease; Aged; Aged, 80 and over; Cardiovascular Diseases; Enoxaparin; Factor Xa; Factor Xa In | 2016 |
Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.
Topics: Acute Disease; Aged; Aged, 80 and over; Cardiovascular Diseases; Enoxaparin; Factor Xa; Factor Xa In | 2016 |
Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.
Topics: Acute Disease; Aged; Aged, 80 and over; Cardiovascular Diseases; Enoxaparin; Factor Xa; Factor Xa In | 2016 |
Andexanet Alfa for Acute Major Bleeding Associated with Factor Xa Inhibitors.
Topics: Acute Disease; Aged; Aged, 80 and over; Cardiovascular Diseases; Enoxaparin; Factor Xa; Factor Xa In | 2016 |
Relations between bleeding and outcomes in patients with ST-elevation myocardial infarction in the ExTRACT-TIMI 25 trial.
Topics: Aged; Cause of Death; Drug Therapy, Combination; Enoxaparin; Female; Fibrinolytic Agents; Hemorrhage | 2010 |
Is early venous thromboembolism prophylaxis safe in trauma patients with intracranial hemorrhage.
Topics: Adult; Age Factors; Anticoagulants; Enoxaparin; Female; Humans; Injury Severity Score; Intracranial | 2011 |
A randomized, double-blinded, placebo-controlled pilot trial of anticoagulation in low-risk traumatic brain injury: The Delayed Versus Early Enoxaparin Prophylaxis I (DEEP I) study.
Topics: Adult; Anticoagulants; Brain Injuries; Double-Blind Method; Enoxaparin; Female; Humans; Intracranial | 2012 |
Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction.
Topics: Aged; Anticoagulants; Drug Therapy, Combination; Electrocardiography; Enoxaparin; Female; Fibrinolyt | 2006 |
Randomized comparison of enoxaparin, a low-molecular-weight heparin, with unfractionated heparin adjunctive to recombinant tissue plasminogen activator thrombolysis and aspirin: second trial of Heparin and Aspirin Reperfusion Therapy (HART II).
Topics: Anticoagulants; Aspirin; Coronary Angiography; Coronary Circulation; Enoxaparin; Female; Heparin; He | 2001 |
Randomized, pilot study of intermittent pneumatic compression devices plus dalteparin versus intermittent pneumatic compression devices plus heparin for prevention of venous thromboembolism in patients undergoing craniotomy.
Topics: Adult; Aged; Anticoagulants; Combined Modality Therapy; Craniotomy; Dalteparin; Female; Heparin; Hum | 2003 |
16 other studies available for dalteparin and Intracranial Hemorrhages
| Article | Year |
|---|---|
[Intracranial hemorrhage due to pulmonary thromboembolism in heparin therapy and therapeutic management of patients hospitalized with massive pulmonary embolism after discharge].
Topics: Angiography; Anticoagulants; Embolectomy; Female; Heparin; Heparin, Low-Molecular-Weight; Humans; In | 2013 |
Early venous thromboembolism prophylaxis in patients with trauma intracranial hemorrhage: Analysis of the prospective multicenter Consortium of Leaders in Traumatic Thromboembolism study.
Topics: Anticoagulants; Enoxaparin; Heparin; Humans; Intracranial Hemorrhage, Traumatic; Intracranial Hemorr | 2023 |
Effective use of weight-based enoxaparin for deep vein thrombosis chemoprophylaxis in patients with traumatic brain injury.
Topics: Adult; Aged; Anticoagulants; Body Weight; Brain Injuries, Traumatic; Drug Dosage Calculations; Enoxa | 2022 |
Predicting the higher rate of intracranial hemorrhage in glioma patients receiving therapeutic enoxaparin.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Brain Neoplasms; Cohort Studies; Enoxaparin; Female; | 2017 |
Delayed Catheter-Related Intracranial Hemorrhage After a Ventriculoperitoneal or Ventriculoatrial Shunt in Hydrocephalus.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Brain; Cerebrospinal Fluid Shunts; Enoxaparin; Femal | 2017 |
The impact of enoxaparin administration in relationship to hemorrhage in mild traumatic brain injury.
Topics: Animals; Anticoagulants; Brain Concussion; Disease Models, Animal; Enoxaparin; Intracranial Hemorrha | 2018 |
Intracranial hemorrhage in patients with brain metastases treated with therapeutic enoxaparin: a matched cohort study.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Boston; Brain Neoplasms; Case-Control Studies; Enoxa | 2015 |
Unfractionated heparin-clopidogrel combination in ST-elevation myocardial infarction not receiving reperfusion therapy.
Topics: Aged; Anticoagulants; Clopidogrel; Drug Therapy, Combination; Enoxaparin; Europe; Female; Fibrinolyt | 2015 |
Balancing bleeding in brain metastases.
Topics: Anticoagulants; Brain Neoplasms; Enoxaparin; Female; Humans; Intracranial Hemorrhages; Male; Neoplas | 2015 |
Antithrombotic Medication Use and Misuse Among Patients with Intracranial Hemorrhage: A 16-Year, Lebanese, Single-Center Experience.
Topics: Acenocoumarol; Adult; Aged; Aged, 80 and over; Anticoagulants; Aspirin; Atrial Fibrillation; Cerebra | 2016 |
Adjuvant enoxaparin therapy may decrease the incidence of postoperative thrombotic events though does not increase the incidence of postoperative intracranial hemorrhage in patients with meningiomas.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Chemotherapy, Adjuvant; Enoxaparin; Female; Humans; | 2009 |
Advances in antithrombotic therapy in acute myocardial infarction: the ExTRACT-TIMI 25 and OASIS-6 Trials.
Topics: Angioplasty, Balloon, Coronary; Anticoagulants; Clinical Trials, Phase III as Topic; Drug Therapy, C | 2006 |
Intracranial bleed in a pregnant patient on oral anticoagulants for prosthetic heart valve.
Topics: Acenocoumarol; Adult; Anticoagulants; Aortic Valve; Enoxaparin; Female; Heart Valve Prosthesis; Huma | 2001 |
Venous thromboembolism during pregnancy: a retrospective study of enoxaparin safety in 624 pregnancies.
Topics: Adult; Anticoagulants; Cerebral Hemorrhage; Enoxaparin; Female; Humans; Infant, Newborn; Intracrania | 2001 |
Early antithrombotic prophylaxis with low molecular weight heparin in neurosurgery.
Topics: Adult; Aged; Aged, 80 and over; Brain Injuries; Brain Neoplasms; Cerebrospinal Fluid Shunts; Contrai | 2003 |
Management of unstable coronary-artery disease.
Topics: Anticoagulants; Coronary Disease; Dalteparin; Humans; Intracranial Hemorrhages | 2000 |