gordox: Drugs having as their active substance aprotinin (trasylol, gordox); gordox and contrycal are distinct molecules that both act as kallikrenin protease inhibitors [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]
| ID Source | ID |
|---|---|
| PubMed CID | 16130295 |
| MeSH ID | M0011905 |
| Synonym |
|---|
| inhibin |
| trazinin |
| bayer a 128 |
| zymofren |
| rp-9921 |
| rpdfcleppytgpckariiryfynakaglcqtfvyggcrakrnnfksaedcmrtcgga |
| riker 52g |
| iniprol |
| protimbin |
| onquinin |
| trypsin-kallikrein inhibitor (kunitz) |
| basic protease inhibitor |
| kunitz and northrop inhibitor |
| trascolan |
| kir richter |
| antikrein |
| contrykal |
| tzalol |
| rp 9921 |
| pancreatic trypsin inhibitor |
| basic pancreatic trypsin inhibitor |
| aprotinina [inn-spanish] |
| gordox |
| antagosan |
| antilysine |
| aprotinine [inn-french] |
| aprotinin bovine |
| einecs 232-994-9 |
| bpti |
| pantinol |
| pancreatic basic trypsin inhibitor |
| repulson |
| pancreatic trypsin inhibitor (kunitz) |
| fosten |
| kallikrein-trypsin inactivator |
| trypsin inhibitor |
| trypsin inhibitor, pancreatic basic |
| aprotininum [inn-latin] |
| baya0128 |
| aprotinina |
| aprotinine |
| aprotininum |
| unii-04xpw8c0fl |
| hsdb 7502 |
| aprotinin [usan:usp:inn:ban] |
| 04xpw8c0fl , |
| gtpl6570 |
| basic protease inhibitor (bpi) |
| Assay ID | Title | Year | Journal | Article |
|---|---|---|---|---|
| AID1345923 | Human plasminogen (S1: Chymotrypsin) | 2007 | Journal of thrombosis and haemostasis : JTH, Oct, Volume: 5, Issue:10 | Evaluation of aprotinin and tranexamic acid in different in vitro and in vivo models of fibrinolysis, coagulation and thrombus formation. |
| [information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||||
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 10 (41.67) | 18.7374 |
| 1990's | 7 (29.17) | 18.2507 |
| 2000's | 6 (25.00) | 29.6817 |
| 2010's | 1 (4.17) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 5 (13.51%) | 5.53% |
| Reviews | 2 (5.41%) | 6.00% |
| Case Studies | 1 (2.70%) | 4.05% |
| Observational | 0 (0.00%) | 0.25% |
| Other | 29 (78.38%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy [NCT02545153] | Phase 2 | 200 participants (Anticipated) | Interventional | 2009-01-31 | Recruiting | ||
| A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery [NCT00668031] | Phase 3 | 359 participants (Actual) | Interventional | 2005-02-28 | Completed | ||
| Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Trans [NCT00611845] | 0 participants | Expanded Access | No longer available | ||||
| An Exploratory Phase 2 Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 S-APR for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery [NCT00681824] | Phase 2 | 95 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving [NCT00257751] | 400 participants (Anticipated) | Interventional | 2004-03-31 | Completed | |||
| Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery [NCT00892957] | Phase 3 | 176 participants (Actual) | Interventional | 2009-07-31 | Completed | ||
| Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates [NCT00617955] | 462 participants (Actual) | Observational | 2007-09-30 | Completed | |||
| Phase I Study of Aprotinin in Advanced Breast Cancer [NCT00354900] | Phase 1 | 18 participants | Interventional | 2006-07-31 | Terminated(stopped due to The FDA changed the labeling for this agent, and we felt we could not offer it to patients on a non-surgical study.) | ||
| An Open, Randomised, Prospective, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy [NCT00290836] | Phase 4 | 120 participants | Interventional | 2004-05-31 | Completed | ||
| A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery [NCT00327379] | Phase 3 | 54 participants (Actual) | Interventional | 2006-02-27 | Terminated | ||
| Investigation of Leukocyte Trafficking Into Skin Blisters During Cardiopulmonary Bypass [NCT00131040] | 24 participants | Interventional | 2003-01-31 | Completed | |||
| The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization [NCT00396760] | Phase 3 | 220 participants | Interventional | 2005-01-31 | Active, not recruiting | ||
| [NCT00395369] | 30 participants | Interventional | 2007-12-31 | Not yet recruiting | |||
| An Exploratory Phase 2 Clinical Study to Evaluate Efficacy and Safety of the Adjuvant Use of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4) in Subjects Undergoing Rhytidectomy [NCT00708071] | Phase 2 | 45 participants (Actual) | Interventional | 2008-06-30 | Completed | ||
| A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy. [NCT00306150] | Phase 3 | 57 participants (Actual) | Interventional | 2005-12-31 | Terminated | ||
| A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer [NCT00306137] | Phase 3 | 104 participants (Actual) | Interventional | 2005-12-31 | Terminated | ||
| [NCT00357851] | Phase 1 | 120 participants (Anticipated) | Interventional | 2005-03-31 | Completed | ||
| An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19 [NCT04527133] | 30 participants (Actual) | Interventional | 2020-06-11 | Active, not recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage." (NCT00681824)
Timeframe: 33 +/- 3 days after surgery
| Intervention | percentage of participants (Number) |
|---|---|
| Standard of Care (SoC) | 74.07 |
| FS VH S/D 500 S-apr | 78.13 |
(NCT00681824)
Timeframe: within 1 month following surgery
| Intervention | percentage of participants (Number) |
|---|---|
| Standard of Care | 0.00 |
| FS VH S/D 500 S-apr | 2.17 |
"Study-relevant CSF leakage is defined as one or more of following:~Discrete subcutaneous or subgaleal CSF collection (pseudomeningocele) in surgical area confirmed by positive test for β2-transferrin, or by computed tomography (CT) or magnetic resonance imaging (MRI)~Epidural CSF collection in surgical area depicted by CT or MRI~Leakage of CSF through surgical wound observed during physical examination, confirmed by a positive test for β2-transferrin~Progressive pneumatocephalus (air in subarachnoidal space) depicted by repeat CT in absence of CSF drainage." (NCT00681824)
Timeframe: 33 +/- 3 days after surgery
| Intervention | participants (Number) |
|---|---|
| Standard of Care (SoC) | 20 |
| FS VH S/D 500 S-apr | 25 |
(NCT00681824)
Timeframe: within 1 month following surgery
| Intervention | participants (Number) |
|---|---|
| Standard of Care | 0 |
| FS VH S/D 500 S-apr | 1 |
The incidence of surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures (NCT00681824)
Timeframe: until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Surgical Revision | Compression Bandage | Liquor Drainage | |
| FS VH S/D 500 S-apr | 3.03 | 0 | 0 |
| Standard of Care (SoC) | 0 | 0 | 0 |
The number of participants with surgical revisions, number and duration of compression bandage applications and of liquor drainage procedures. (NCT00681824)
Timeframe: until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first
| Intervention | participants (Number) | ||
|---|---|---|---|
| Surgical Revision | Compression Bandage | Liquor Drainage | |
| FS VH S/D 500 S-apr | 1 | 0 | 0 |
| Standard of Care (SoC) | 0 | 0 | 0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 5
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 7
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 3
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | -0.2 |
"Difference between each side of the face are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Postoperative Day 3
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.00 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 1
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 10
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 14
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 3
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 5
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used MMS during examinations- postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color & affects limited area); Grade 2= Present, minimal (yellow color & covers ≤25% of operated area); Grade 3= Moderate (yellow color & covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color & covers more than just very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 7
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
Two-point discrimination test performed by investigators to assess nerve regeneration. Testing performed on each side of the face (SoC and FS VH S/D 4). Differences are calculated as: Postoperative Day - Day 0, reported as minimal distance at which participants were able to discern feeling at two distinct points (NCT00708071)
Timeframe: Postoperative Days 3, 7, 10, and 14
| Intervention | mm (Median) |
|---|---|
| FS VH S/D 4 - Day3 | 7 |
| SoC - Day 3 | 7 |
| FS VH S/D 4 - Day 7 | 5 |
| SoC - Day 7 | 6 |
| FS VH S/D 4 - Day 10 | 5 |
| SoC - Day 10 | 5 |
| FS VH S/D 4 - Day 14 | 0 |
| SoC - Day 14 | 5 |
(NCT00708071)
Timeframe: Through Postoperative Day 14 (± 1)
| Intervention | Adverse Events (Number) |
|---|---|
| Facelift Participants | 0 |
Investigators assessed each side of the face for the presence of hematoma/seroma (NCT00708071)
Timeframe: Through Postoperative Day 14 (± 1)
| Intervention | participants (Number) |
|---|---|
| Participants With Hematoma/Seroma on FS VH S/D 4 Side | 0 |
| Participants With Hematoma/Seroma on SoC Side | 6 |
| Participants With Hematoma/Seroma on Both Sides | 0 |
| Participants With No Hematoma/Seroma on Either Side | 27 |
(NCT00708071)
Timeframe: 24 hours postoperative
| Intervention | mL (Median) |
|---|---|
| Standard of Care (SoC) | 16 |
| FS VH S/D 4 | 5 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 1
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 2 |
| Participants With Less Ecchymosis Treated With SoC | 11 |
| Participants With Equal Ecchymosis On Both Sides | 16 |
| Participants With No Ecchymosis on Either Side | 0 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 10
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 7 |
| Participants With Less Ecchymosis Treated With SoC | 7 |
| Participants With Equal Ecchymosis On Both Sides | 14 |
| Participants With No Ecchymosis on Either Side | 0 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 14
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 5 |
| Participants With Less Ecchymosis Treated With SoC | 6 |
| Participants With Equal Ecchymosis On Both Sides | 14 |
| Participants With No Ecchymosis on Either Side | 1 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 7
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 9 |
| Participants With Less Ecchymosis Treated With SoC | 8 |
| Participants With Equal Ecchymosis On Both Sides | 14 |
| Participants With No Ecchymosis on Either Side | 0 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 3
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 5 |
| Participants With Less Ecchymosis Treated With SoC | 12 |
| Participants With Equal Ecchymosis On Both Sides | 11 |
| Participants With No Ecchymosis on Either Side | 0 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 10
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a numbness assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the numbness experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Days 1, 3, 5, 7,10, and 14
| Intervention | Scores on a scale (Median) | |||||
|---|---|---|---|---|---|---|
| Day 1 | Day 3 | Day 5 | Day 7 | Day 10 | Day 14 | |
| Facelift Participants | 0 | 0 | 0 | 0 | 0 | 0 |
"Differences are calculated as (Grade for SoC) - (Grade for FS VH S/D 4). Participants used a 10-point visual analogue scale to complete a pain assessment for each side of their face during each postoperative study visit (Days 1, 3, 5, 7, 10, and 14). The higher the number, the greater the pain experienced, i.e. 10 = worst, 1 = least.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Days 1, 3, 5, 7,10, and 14
| Intervention | Scores on a scale (Median) | |||||
|---|---|---|---|---|---|---|
| Day 1 | Day 3 | Day 5 | Day 7 | Day 10 | Day 14 | |
| Facelift Participants | 0 | 0 | 0 | 0 | 0 | 0 |
Investigators assessed each side of the face for the presence of hematoma/seroma (NCT00708071)
Timeframe: Days 0, 1, 3, 5, 7,10, and 14
| Intervention | Participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Day 0 | Day 1 | Day 3 | Day 5 | Day 7 | Day 10 | Day 14 | |
| FS VH S/D 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Standard of Care (SoC) | 2 | 1 | 2 | 1 | 1 | 2 | 1 |
Participants compared the levels of bruising on each side of their face and determine if they had a preference for the look of 1 side over another. (NCT00708071)
Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Day 1 | Day 3 | Day 5 | Day 7 | Day 10 | Day 14 | |
| FS VH S/D 4 Looks Better | 12 | 20 | 17 | 17 | 13 | 12 |
| No Difference | 5 | 1 | 2 | 2 | 5 | 5 |
| SoC Looks Better | 16 | 12 | 14 | 14 | 15 | 15 |
Resolution of ecchymosis (grade 0 on the Modified Marchac Scale for ecchymosis (Grade 0 = No bruising at all)) (NCT00708071)
Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| By Day 1 | By Day 3 | By Day 5 | By Day 7 | By Day 10 | By Day 14 | |
| Complete Resolution of Ecchymosis With FS VH S/D 4 But Not SoC | 0 | 0 | 1 | 1 | 1 | 1 |
| Complete Resolution of Ecchymosis With SoC But Not FS VH S/D 4 | 0 | 0 | 0 | 0 | 0 | 3 |
| Participants With Complete Resolution on Both Sides | 2 | 1 | 0 | 0 | 1 | 7 |
| Participants With No Resolution on Either Side | 31 | 32 | 32 | 32 | 31 | 22 |
Resolution of edema (grade 1 on the Marchac Scale for Edema (Grade 1 = Nil) (NCT00708071)
Timeframe: Postoperative Days 1, 3, 5, 7, 10, and 14
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| By Day 1 (n=32) | By Day 3 (n=33) | By Day 5 (n=33) | By Day 7 (n=33) | By Day 10 (n=32) | By Day 14 (n=32) | |
| Complete Resolution of Edema With FS VH S/D 4 But Not SoC | 3 | 0 | 0 | 1 | 1 | 4 |
| Complete Resolution of Edema With SoC But Not FS VH S/D 4 | 0 | 0 | 0 | 0 | 0 | 2 |
| Participants With Complete Resolution on Both Sides | 0 | 0 | 0 | 1 | 1 | 6 |
| Participants With No Resolution on Either Side | 29 | 33 | 33 | 33 | 30 | 20 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4.~Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil, Grade 2= Minor, Grade 3= Moderate, Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 1
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.00 |
Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. (NCT00708071)
Timeframe: Through Postoperative Day 5
| Intervention | participants (Number) |
|---|---|
| Participants With Less Ecchymosis Treated With FS VH S/D 4 | 5 |
| Participants With Less Ecchymosis Treated With SoC | 8 |
| Participants With Equal Ecchymosis On Both Sides | 14 |
| Participants With No Ecchymosis on Either Side | 0 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 14
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 3
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 5
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators used the modified Marchac grading to evaluate edema during participant examinations on postoperative Day 1, 3, 5, 7, 10, and 14. The evaluations were performed on both sides of the face. Differences are calculated as Grade for Standard of Care - Grade for FS VH S/D 4. Marchac Scale for Post Rhytidectomy (Facelift) Edema: Grade 1= Nil; Grade 2= Minor; Grade 3= Moderate; Grade 4= Marked/unusual amount.~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 7
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 1
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 10
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers >25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color)~The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests." (NCT00708071)
Timeframe: Through Postoperative Day 14
| Intervention | Scores on a scale (Median) |
|---|---|
| Facelift Participants | 0.0 |
"Investigators were shown videos of bleeding severities to standardize assessments.~Moderate bleeding defined as:~Either >25% of the suture line bleeds, or~≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or~1 pulsatile suture line bleeding was present." (NCT00892957)
Timeframe: 4 minutes post start of treatment application
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 75.9 |
| Control - Manual Compression With Surgical Gauze | 48.1 |
"Investigators were shown videos of bleeding severities to standardize assessments.~Severe bleeding defined as:~Either >50% of the suture line bleeds, or~≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or~>1 pulsatile suture line bleeding was present, or~≥1 spurting suture line bleeding was present." (NCT00892957)
Timeframe: 4 minutes post start of treatment application
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 53.7 |
| Control - Manual Compression With Surgical Gauze | 20.9 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | U/L (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 16.0 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 16.0 |
| Control Group: Preoperative Baseline | 14.0 |
| Control Group: Postoperative Day 14 | 13.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | U/L (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 21.0 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 20.5 |
| Control Group: Preoperative Baseline | 19.0 |
| Control Group: Postoperative Day 14 | 20.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | x10^6/µl (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 4.20 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 3.90 |
| Control Group: Preoperative Baseline | 4.10 |
| Control Group: Postoperative Day 14 | 3.90 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | percentage of red blood cells in blood (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 37.0 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 36.0 |
| Control Group: Preoperative Baseline | 38.5 |
| Control Group: Postoperative Day 14 | 37.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | g/dL (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 12.10 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 11.60 |
| Control Group: Preoperative Baseline | 12.20 |
| Control Group: Postoperative Day 14 | 11.80 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | ratio (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 1.00 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 1.00 |
| Control Group: Preoperative Baseline | 1.00 |
| Control Group: Postoperative Day 14 | 1.00 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | x10^3/µl (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 227.0 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 303.0 |
| Control Group: Preoperative Baseline | 239.0 |
| Control Group: Postoperative Day 14 | 283.0 |
Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 (NCT00892957)
Timeframe: Within 14 days prior to surgery through postoperative day 14
| Intervention | percent change (Median) |
|---|---|
| FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0 | -6.27 |
| Control: Preop Baseline - Intraoperative Day 0 | -2.12 |
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 | 5.44 |
| Control: Preop Baseline - Postoperative Day 1 | 4.84 |
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14 | 5.63 |
| Control: Preop Baseline - Postoperative Day 14 | 0.00 |
Percent Change in Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 (NCT00892957)
Timeframe: Within 14 days prior to surgery through postoperative day 14
| Intervention | percent change (Median) |
|---|---|
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 | -10.00 |
| Control: Preop Baseline - Postoperative Day 1 | -9.55 |
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14 | 0.00 |
| Control: Preop Baseline - Postoperative Day 14 | -6.07 |
Hemostasis at the study suture line must be maintained until closure of the surgical wound. (NCT00892957)
Timeframe: 10 minutes post start of treatment application
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 75.7 |
| Control - Manual Compression With Surgical Gauze | 55.7 |
Hemostasis at the study suture line must be maintained until closure of the surgical wound. (NCT00892957)
Timeframe: 4 minutes post start of treatment application
| Intervention | Percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 62.9 |
| Control - Manual Compression With Surgical Gauze | 31.4 |
Hemostasis at the study suture line must be maintained until closure of the surgical wound. (NCT00892957)
Timeframe: 6 minutes post start of treatment application
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 71.4 |
| Control - Manual Compression With Surgical Gauze | 42.9 |
Determined clinically and defined as absence of blood flow through the graft. (NCT00892957)
Timeframe: post-op discharge/day 1, post-op day 14 and day 30
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 7.1 |
| Control - Manual Compression With Surgical Gauze | 11.4 |
(NCT00892957)
Timeframe: post-op discharge/day 1, post-op day 14 and day 30
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 10.0 |
| Control - Manual Compression With Surgical Gauze | 7.1 |
Intraoperative rebleeding at the study suture line after occurrence of hemostasis. (NCT00892957)
Timeframe: Intraoperative day 0
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 5.7 |
| Control - Manual Compression With Surgical Gauze | 1.4 |
Any rebleeding requiring surgical re-exploration (NCT00892957)
Timeframe: Postoperative through day 30 ± 5
| Intervention | percentage of participants (Number) |
|---|---|
| FS VH S/D 500 S-apr | 0 |
| Control - Manual Compression With Surgical Gauze | 0 |
(NCT00892957)
Timeframe: Within 14 days prior to date of surgery
| Intervention | breaths per minute (Median) |
|---|---|
| FS VH S/D 500 S-apr | 18.0 |
| Control - Manual Compression With Surgical Gauze | 18.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | mg/dL (Median) | ||
|---|---|---|---|
| Creatinine | Bilirubin | BUN | |
| Control Group: Postoperative Day 14 | 4.40 | 0.30 | 30.0 |
| Control Group: Preoperative Baseline | 2.90 | 0.30 | 22.0 |
| FS VH S/D 500 S-apr: Baseline | 1.80 | 0.30 | 23.0 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 2.20 | 0.30 | 23.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | x10^3/µl (Median) | |||||
|---|---|---|---|---|---|---|
| Leukocytes | Basophils | Eosinophils | Lymphocytes | Neutrophils | Monocytes | |
| Control Group: Postoperative Day 14 | 7.980 | 0.050 | 0.220 | 1.750 | 5.150 | 0.460 |
| Control Group: Preoperative Baseline | 6.760 | 0.040 | 0.160 | 1.700 | 4.560 | 0.400 |
| FS VH S/D 500 S-apr: Baseline | 7.105 | 0.040 | 0.180 | 1.805 | 4.585 | 0.370 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 8.260 | 0.040 | 0.200 | 1.800 | 5.570 | 0.430 |
"Infections were recorded according to:~Grade I: only dermis affected~Grade II: infection invades subcutaneous region but not the arterial implant~Grade III: the arterial implant is infected" (NCT00892957)
Timeframe: post-op discharge/day 1, post-op day 14 and day 30
| Intervention | participants (Number) | ||
|---|---|---|---|
| Grade I | Grade II | Grade III | |
| Control - Manual Compression With Surgical Gauze | 3 | 1 | 1 |
| FS VH S/D 500 S-apr | 5 | 2 | 0 |
Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14 (NCT00892957)
Timeframe: Within 14 days prior to surgery through postoperative day 14
| Intervention | percent change (Median) | |
|---|---|---|
| Systolic BP | Diastolic BP (Control Postoperative Day 14 N=64) | |
| Control: Preop Baseline - Intraoperative Day 0 | -12.46 | -16.87 |
| Control: Preop Baseline - Postoperative Day 1 | -7.72 | -16.84 |
| Control: Preop Baseline - Postoperative Day 14 | -2.94 | -7.30 |
| FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0 | -15.63 | -17.29 |
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1 | -8.33 | -11.58 |
| FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14 | -2.59 | -2.64 |
(NCT00892957)
Timeframe: Within 14 days prior to date of surgery
| Intervention | mm Hg (Median) | |
|---|---|---|
| Systolic blood pressure | Diastolic blood pressure | |
| Control - Manual Compression With Surgical Gauze | 143.5 | 76.5 |
| FS VH S/D 500 S-apr | 139.5 | 73.0 |
(NCT00892957)
Timeframe: Within 14 days prior to date of surgery
| Intervention | beats per minute (Median) |
|---|---|
| FS VH S/D 500 S-apr | 75.0 |
| Control - Manual Compression With Surgical Gauze | 75.0 |
(NCT00892957)
Timeframe: Preoperative baseline through postoperative Day 14
| Intervention | seconds (Median) |
|---|---|
| FS VH S/D 500 S-apr: Baseline | 24.40 |
| FS VH S/D 500 S-apr: Postoperative Day 14 | 25.10 |
| Control Group: Preoperative Baseline | 25.20 |
| Control Group: Postoperative Day 14 | 25.80 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| thiosulfates Thiosulfates: Inorganic salts of thiosulfuric acid possessing the general formula R2S2O3.. thiosulfate(2-) : A divalent inorganic anion obtained by removal of both protons from thiosulfuric acid. | 3.37 | 1 | 1 | divalent inorganic anion; sulfur oxide; sulfur oxoanion | human metabolite |
| pirenzepine Pirenzepine: An antimuscarinic agent that inhibits gastric secretion at lower doses than are required to affect gastrointestinal motility, salivary, central nervous system, cardiovascular, ocular, and urinary function. It promotes the healing of duodenal ulcers and due to its cytoprotective action is beneficial in the prevention of duodenal ulcer recurrence. It also potentiates the effect of other antiulcer agents such as CIMETIDINE and RANITIDINE. It is generally well tolerated by patients. | 1.96 | 1 | 0 | pyridobenzodiazepine | anti-ulcer drug; antispasmodic drug; muscarinic antagonist |
| tranexamic acid Tranexamic Acid: Antifibrinolytic hemostatic used in severe hemorrhage. | 7.43 | 2 | 0 | amino acid | |
| spironolactone Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. | 3.37 | 1 | 1 | 3-oxo-Delta(4) steroid; oxaspiro compound; steroid lactone; thioester | aldosterone antagonist; antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
| triamcinolone acetonide Triamcinolone Acetonide: An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.. triamcinolone acetonide : A synthetic glucocorticoid that is the 16,17-acetonide of triamcinolone. Used to treat various skin infections. | 3.36 | 1 | 1 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; cyclic ketal; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone | anti-allergic agent; anti-inflammatory drug |
| n-vinyl-2-pyrrolidinone N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source | 3.76 | 2 | 1 | pyrrolidin-2-ones | |
| epichlorohydrin Epichlorohydrin: A chlorinated epoxy compound used as an industrial solvent. It is a strong skin irritant and carcinogen.. epichlorohydrin : An epoxide that is 1,2-epoxypropene in which one of the methyl hydrogens is substituted by chlorine. | 1.97 | 1 | 0 | epoxide; organochlorine compound | |
| nandrolone decanoate Nandrolone Decanoate: Decanoic acid ester of nandrolone that is used as an anabolic agent to prevent or treat WASTING SYNDROME associated with severe chronic illness or HIV infection (HIV WASTING SYNDROME). It may also be used in the treatment of POSTMENOPAUSAL OSTEOPOROSIS. | 1.97 | 1 | 0 | steroid ester | |
| nandrolone Nandrolone: C18 steroid with androgenic and anabolic properties. It is generally prepared from alkyl ethers of ESTRADIOL to resemble TESTOSTERONE but less one carbon at the 19 position.. nandrolone : A 3-oxo Delta(4)-steroid that is estr-4-en-3-one substituted by a beta-hydroxy group at position 17. | 1.97 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; anabolic androgenic steroid | human metabolite |
| malondialdehyde Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form. | 1.96 | 1 | 0 | dialdehyde | biomarker |
| sodium hydroxide Sodium Hydroxide: A highly caustic substance that is used to neutralize acids and make sodium salts. (From Merck Index, 11th ed) | 1.97 | 1 | 0 | alkali metal hydroxide | |
| d-alpha tocopherol Vitamin E: A generic descriptor for all TOCOPHEROLS and TOCOTRIENOLS that exhibit ALPHA-TOCOPHEROL activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of ISOPRENOIDS.. tocopherol : A collective name for a group of closely related lipids that contain a chroman-6-ol nucleus substituted at position 2 by a methyl group and by a saturated hydrocarbon chain consisting of three isoprenoid units. They are designated as alpha-, beta-, gamma-, and delta-tocopherol depending on the number and position of additional methyl substituents on the aromatic ring. Tocopherols occur in vegetable oils and vegetable oil products, almost exclusively with R,R,R configuration. Tocotrienols differ from tocopherols only in having three double bonds in the hydrocarbon chain.. vitamin E : Any member of a group of fat-soluble chromanols that exhibit biological activity against vitamin E deficiency. The vitamers in this class consists of a chroman-6-ol core which is substituted at position 2 by a methyl group and (also at position 2) either a saturated or a triply-unsaturated hydrocarbon chain consisting of three isoprenoid units. The major function of vitamin E is to act as a natural antioxidant by scavenging free radicals and molecular oxygen.. (R,R,R)-alpha-tocopherol : An alpha-tocopherol that has R,R,R configuration. The naturally occurring stereoisomer of alpha-tocopherol, it is found particularly in sunflower and olive oils. | 1.96 | 1 | 0 | alpha-tocopherol | algal metabolite; antiatherogenic agent; anticoagulant; antioxidant; antiviral agent; EC 2.7.11.13 (protein kinase C) inhibitor; immunomodulator; micronutrient; nutraceutical; plant metabolite |
| sodium thiosulfate sodium thiosulfate: do not confuse synonym sodium hyposulfite with sodium hyposulfite, synonym for di-Na salt of dithionous acid. sodium thiosulfate : An inorganic sodium salt composed of sodium and thiosulfate ions in a 2:1 ratio. | 3.37 | 1 | 1 | inorganic sodium salt | antidote to cyanide poisoning; antifungal drug; nephroprotective agent |
| thymic factor, circulating thymalin: see also thymarin | 1.98 | 1 | 0 | ||
| sodium oxybate Sodium Oxybate: The sodium salt of 4-hydroxybutyric acid. It is used for both induction and maintenance of ANESTHESIA. | 3.37 | 1 | 1 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Blood Clot [description not available] | 0 | 2.03 | 1 | 0 |
| Thrombosis Formation and development of a thrombus or blood clot in the blood vessel. | 0 | 2.03 | 1 | 0 |
| Phlegmon [description not available] | 0 | 2.02 | 1 | 0 |
| Cellulitis An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions. | 0 | 2.02 | 1 | 0 |
| Recrudescence [description not available] | 0 | 3.4 | 1 | 1 |
| Acute Edematous Pancreatitis [description not available] | 0 | 5.37 | 5 | 1 |
| Acute Disease Disease having a short and relatively severe course. | 0 | 3.77 | 2 | 1 |
| Pancreatitis INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis. | 0 | 5.37 | 5 | 1 |
| Cardiovascular Stroke [description not available] | 0 | 5.19 | 4 | 1 |
| Injury, Myocardial Reperfusion [description not available] | 0 | 3.41 | 1 | 1 |
| Myocardial Infarction NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION). | 0 | 5.19 | 4 | 1 |
| Blood Poisoning [description not available] | 0 | 2.38 | 2 | 0 |
| Burns Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like. | 0 | 3.28 | 2 | 0 |
| Toxemia A condition produced by the presence of toxins or other harmful substances in the BLOOD. | 0 | 1.95 | 1 | 0 |
| Sepsis Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK. | 0 | 2.38 | 2 | 0 |
| Asthma, Bronchial [description not available] | 0 | 2.87 | 1 | 0 |
| Bacterial Disease [description not available] | 0 | 2.87 | 1 | 0 |
| Coagulation Disorders, Blood [description not available] | 0 | 2.87 | 1 | 0 |
| Grippe [description not available] | 0 | 2.87 | 1 | 0 |
| Carditis [description not available] | 0 | 2.87 | 1 | 0 |
| Circulatory Collapse [description not available] | 0 | 2.87 | 1 | 0 |
| Staphylococcal Pneumonia [description not available] | 0 | 2.87 | 1 | 0 |
| Asthma A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL). | 0 | 2.87 | 1 | 0 |
| Bacterial Infections Infections by bacteria, general or unspecified. | 0 | 2.87 | 1 | 0 |
| Blood Coagulation Disorders Hemorrhagic and thrombotic disorders that occur as a consequence of abnormalities in blood coagulation due to a variety of factors such as COAGULATION PROTEIN DISORDERS; BLOOD PLATELET DISORDERS; BLOOD PROTEIN DISORDERS or nutritional conditions. | 0 | 2.87 | 1 | 0 |
| Influenza, Human An acute viral infection in humans involving the respiratory tract. It is marked by inflammation of the NASAL MUCOSA; the PHARYNX; and conjunctiva, and by headache and severe, often generalized, myalgia. | 0 | 2.87 | 1 | 0 |
| Myocarditis Inflammatory processes of the muscular walls of the heart (MYOCARDIUM) which result in injury to the cardiac muscle cells (MYOCYTES, CARDIAC). Manifestations range from subclinical to sudden death (DEATH, SUDDEN). Myocarditis in association with cardiac dysfunction is classified as inflammatory CARDIOMYOPATHY usually caused by INFECTION, autoimmune diseases, or responses to toxic substances. Myocarditis is also a common cause of DILATED CARDIOMYOPATHY and other cardiomyopathies. | 0 | 2.87 | 1 | 0 |
| Pneumonia, Staphylococcal Pneumonia caused by infections with bacteria of the genus STAPHYLOCOCCUS, usually with STAPHYLOCOCCUS AUREUS. | 0 | 2.87 | 1 | 0 |
| Shock A pathological condition manifested by failure to perfuse or oxygenate vital organs. | 0 | 2.87 | 1 | 0 |
| alpha 1-Antitrypsin Deficiency Deficiency of the protease inhibitor ALPHA 1-ANTITRYPSIN that manifests primarily as PULMONARY EMPHYSEMA and LIVER CIRRHOSIS. | 0 | 2.87 | 1 | 0 |
| Necrosis The death of cells in an organ or tissue due to disease, injury or failure of the blood supply. | 0 | 2.36 | 2 | 0 |
| Intestinal Obstruction Any impairment, arrest, or reversal of the normal flow of INTESTINAL CONTENTS toward the ANAL CANAL. | 0 | 1.96 | 1 | 0 |
| Chronic Illness [description not available] | 0 | 2.38 | 2 | 0 |
| Obstructive Lung Diseases [description not available] | 0 | 1.98 | 1 | 0 |
| Pulmonary Consumption [description not available] | 0 | 1.98 | 1 | 0 |
| Bronchitis Inflammation of the large airways in the lung including any part of the BRONCHI, from the PRIMARY BRONCHI to the TERTIARY BRONCHI. | 0 | 1.98 | 1 | 0 |
| Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). | 0 | 2.38 | 2 | 0 |
| Lung Diseases, Obstructive Any disorder marked by obstruction of conducting airways of the lung. AIRWAY OBSTRUCTION may be acute, chronic, intermittent, or persistent. | 0 | 1.98 | 1 | 0 |
| Tuberculosis, Pulmonary MYCOBACTERIUM infections of the lung. | 0 | 1.98 | 1 | 0 |
| Bile Duct Obstruction [description not available] | 0 | 3.37 | 1 | 1 |
| Cholestasis Impairment of bile flow due to obstruction in small bile ducts (INTRAHEPATIC CHOLESTASIS) or obstruction in large bile ducts (EXTRAHEPATIC CHOLESTASIS). | 0 | 3.37 | 1 | 1 |
| Cornea Injuries [description not available] | 0 | 1.97 | 1 | 0 |
| Burns, Chemical Burns caused by contact with or exposure to CAUSTICS or strong ACIDS. | 0 | 2.67 | 3 | 0 |
| Eye Burns Injury to any part of the eye by extreme heat, chemical agents, or ultraviolet radiation. | 0 | 2.89 | 4 | 0 |
| Corneal Injuries Damage or trauma inflicted to the CORNEA by external means. | 0 | 1.97 | 1 | 0 |
| Cancer of Kidney [description not available] | 0 | 1.97 | 1 | 0 |
| Benign Neoplasms [description not available] | 0 | 1.97 | 1 | 0 |
| Bilateral Wilms Tumor [description not available] | 0 | 1.97 | 1 | 0 |
| Kidney Neoplasms Tumors or cancers of the KIDNEY. | 0 | 1.97 | 1 | 0 |
| Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. | 0 | 1.97 | 1 | 0 |
| Wilms Tumor A malignant kidney tumor, caused by the uncontrolled multiplication of renal stem (blastemal), stromal (STROMAL CELLS), and epithelial (EPITHELIAL CELLS) elements. However, not all three are present in every case. Several genes or chromosomal areas have been associated with Wilms tumor which is usually found in childhood as a firm lump in a child's side or ABDOMEN. | 0 | 1.97 | 1 | 0 |
| Retroperitoneal Neoplasms New abnormal growth of tissue in the RETROPERITONEAL SPACE. | 0 | 1.97 | 1 | 0 |
| Arthritis, Degenerative [description not available] | 0 | 3.36 | 1 | 1 |
| Osteoarthritis A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans. | 0 | 3.36 | 1 | 1 |
| Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 2 | 1 | 0 |