Clinical trials: Thrombin
Operation Site Bleed
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat.
- Trial name
- Control (NCT00652314)
- Testing
- Thrombi-Gel
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- Vascular Solutions LLC
Persistent or Permanent Nonvalvular Atrial Fibrillation
Long-term Safety in Atrial Fibrillation Patients
The purpose of this study is to provide safety and tolerability data for AZD0837 during long-term treatment (5 years) in patients with non-valvular atrial fibrillation (AF) and one or more additional risk factors for stroke and…
- Trial name
- NCT00645853
- Testing
- AZD0837, VKA INR 2-3
- Volunteers
- 523 people
- Sponsor
- AstraZeneca
Blood Coagulation Disorders, Acute Major Bleeding
Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
The purpose of this study is to evaluate efficacy, safety and tolerance of BERIPLEX® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by coumarin derivatives in subjects who require immediate…
- Trial name
- NCT00708435
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 69 sites in United States, Belarus and 4 more
- Volunteers
- 216 people
- Sponsor
- CSL Behring
End Stage Renal Disease, Thrombosis
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis
This study evaluates the safety and efficacy of AB002 (E-WE thrombin) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts.
- Trial name
- NCT03963895
- Testing
- AB002 Dose 1, AB002 Dose 2
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Aronora, Inc.
Persistent or Permanent Non-valvular Atrial Fibrillation
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
The purpose of this study is to assess the safety and tolerability of AZD0837 in patients with atrial fibrillation who are unable or unwilling to take vitamin K antagonist therapy for up to 3 months.
- Trial name
- NCT00623779
- Testing
- AZD0837, Aspirin
- Where
- 38 sites in Denmark, Norway and 4 more
- Volunteers
- 128 people
- Sponsor
- AstraZeneca
Myocardial Infarction
Novel Biomarkers of Thrombotic Risk
Treatment of patients who have had a heart attack with drugs that prevent formation of blood clots has been shown to reduce the patient's risk of subsequent cardiovascular events such as heart attack, stroke, and death.
- Trial name
- NCT02505217
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- University of Vermont
Bleeding, Blood Loss, Surgical
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and…
- Conditions
- Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates
- Trial name
- NCT02557672
- Testing
- Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Osteoarthritis, Knee
Combined Topical Tranexamic Acid With Floseal® in Total Knee Arthroplasty
Our purpose of this study therefore is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of combined topical application of these two hemostatic agents in different time during…
- Trial name
- NCT03328832
- Testing
- Topical tranexamic acid, Floseal®, rivaroxaban (10mg)
- Where
- Taiwan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Chang Gung Memorial Hospital
Nonvalvular Atrial Fibrillation
Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled…
- Trial name
- NCT00684307
- Testing
- AZD0837, Vitamin-K antagonist at INR 2-3
- Volunteers
- 1,084 people
- Sponsor
- AstraZeneca
Stroke, Secondary Prevention
Dabigatran Etexilate for Secondary Stroke Prevention in Patients With Embolic Stroke of Undetermined Source (RE-SPECT ESUS)
This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months.
- Trial name
- NCT02239120
- Testing
- optional ASA as comedication, ASA 100 mg
- Where
- 569 sites in United States, Argentina and 40 more
- Volunteers
- 5,390 people
- Sponsor
- Boehringer Ingelheim
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma
Thrombosis
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
- Trial name
- DESIR-ABLE (NCT00913133)
- Testing
- Desirudin
- Where
- 16 sites in United States
- Volunteers
- 516 people
- Sponsor
- Canyon Pharmaceuticals, Inc.
Venous Thromboembolism
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement, prevention or treatment…
- Trial name
- vMetrics-AMS (NCT00978445)
- Testing
- vMetrics protocol
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- ZIN Technologies, Inc.
Hemostasis, General Surgery
A Study Evaluating the Safety and Preliminary Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Elective Hepatic Surgery
The Study investigates a new product, sFilm-FS, aimed to help controlling body fluid leakage in general surgery procedures, proposing its use as an adjunct to hemostasis and/or sealing.
- Trial name
- NCT04660721
- Testing
- sFilm-FS, TACHOSIL®
- Where
- 4 sites in United States, Austria and 1 more
- Volunteers
- 33 people
- Sponsor
- Sealantium Medical Ltd.
Failed Total Knee Arthroplasty
Vitagel Revision Total Knee Arthroplasty
This prospective study will evaluate the effectiveness of Vitagel (VG) in reducing blood loss associated with Revision Total Knee Arthroplasty (RTKA) procedures by assessing the patient's change in hemoglobin/hematocrit.
- Trial name
- NCT01923805
- Testing
- Vitagel
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- The Cleveland Clinic
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Atherosclerosis, Myocardial Ischemia
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Particpants With Acute Coronary Syndrome (TRA•CER) (Study P04736)
The study is designed to determine whether vorapaxar, when added to the existing standard of care (eg, aspirin, clopidogrel) for preventing heart attack and stroke in patients with acute coronary syndrome, will yield additional…
- Conditions
- Atherosclerosis, Myocardial Ischemia, Myocardial Infarction
- Trial name
- NCT00527943
- Testing
- Vorapaxar
- Volunteers
- 12,944 people
- Sponsor
- Merck Sharp & Dohme LLC
Deep Venous Thrombosis
Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial
The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children.
- Trial name
- CRETE (NCT03003390)
- Testing
- Enoxaparin
- Where
- 6 sites in United States
- Volunteers
- 51 people
- Sponsor
- Yale University
Epistaxis
Trial Comparing Outcomes With Merocel Packing or Thrombin-JMI for Anterior Epistaxis
Epistaxis is a common problem among people of all ages and backgrounds. However, occasionally epistaxis can be severe enough to require emergency room admission.
- Trial name
- NCT00814333
- Testing
- Thrombin-JMI, Merocel pack
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Kansas Medical Center
Thrombosis
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
- Trial name
- NCT03453060
- Testing
- E-WE Thrombin- Dose 1, E-WE Thrombin- Dose 2, E-WE Thrombin- Dose 3
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Aronora, Inc.