Clinical trials: Thrombin
Factor V Leiden, Prothrombin G20210A
Engagement Study for Participants With Factor V Leiden and Prothrombin G20210A Mutations
This study will enrol individuals who have, or may have, Factor V Leiden or Prothrombin G20210A mutations, which are genetic changes linked to an increased risk of blood clots.
- Trial name
- NCT07584265
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Richmond Research Institute
Spinal Tumor, Spinal Injury
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery.
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis
- Trial name
- NCT07354178
- Testing
- CollaStat®, Floseal®
- Where
- 3 sites in South Korea
- Volunteers
- 130 people
- Sponsor
- DALIM TISSEN Co., Ltd.
Facial Rhytidectomy (Face-lift)
Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
The primary objective of this study is to evaluate the efficacy and safety of fibrin sealant with 4 IU/mL thrombin, vapor heated, solvent detergent treated (FS VH S/D 4) when used to reduce early postoperative bruising in…
- Trial name
- NCT00708071
- Testing
- Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
- Where
- 6 sites in United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Bleeding
A Two-part Study in Edoxaban-treated Healthy Subjects to Establish a Punch Biopsy Bleeding Model and to Evaluate the Effect of a 4-factor Prothrombin Complex Concentrate on Anticoagulation
This Phase 1 study consists of 2 parts. Part 1 will be an open-label, randomized, 2 treatment, 2-way crossover study. Part 2 will be a double-blind (Sponsor unblinded), randomized, placebo controlled, sequential descending…
- Trial name
- NCT02047565
- Testing
- 60mg edoxaban, 180mg edoxaban, 50 IU/kg Beriplex P/N
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Detection and Genotyping of Factor V and Factor II Point Mutations
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA
As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites.
- Trial name
- NCT00959504
- Volunteers
- 275 people, healthy volunteers welcome
- Sponsor
- Illumina, Inc.
Complex Cardiovascular Surgery With Cardiopulmonary Bypass
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular…
- Trial name
- NCT07094087
- Testing
- BE1116, FFP
- Where
- 24 sites in United States, Canada and 2 more
- Volunteers
- 200 people
- Sponsor
- CSL Behring
Heparin-induced Thrombocytopenia Type II
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral…
- Trial name
- NCT00861692
- Testing
- argatroban
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Tanabe Pharma Corporation
Bleeding Cardiac Surgery Patients
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
This is a multicenter, active-control randomized, prospective, Phase 3 study in adult cardiac surgery patients. 420 patients were randomized at 12 hospitals.
- Trial name
- FARES-2 (NCT05523297)
- Testing
- Octaplex, Frozen Plasma Product, Human
- Where
- 13 sites in United States, Canada
- Volunteers
- 420 people
- Sponsor
- Octapharma
Coronary Disease
Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32
The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission).
- Trial name
- NCT00116012
- Testing
- rNAPc2
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- ARCA Biopharma, Inc.
Severe Hemophilia A With Inhibitor
Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors
This is an observational, prospective, longitudinal, multicenter, cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class (devoid or rich of VWF) in…
- Trial name
- PredicTGA (NCT01505946)
- Testing
- TGA (Thrombin generation Assay)
- Where
- 15 sites in Italy
- Volunteers
- 25 people
- Sponsor
- Grifols Italia S.p.A
Surgical Hemostasis
Study of Recombinant Human Thrombin for Bleeding During Autologous Skin Grafting
The purpose of this study is to evaluate whether rThrombin is safe when used for controlling bleeding during skin graft surgery.
- Trial name
- NCT00371215
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- ZymoGenetics
Deep Partial or Full Thickness Wounds
Safety and Efficacy Study of FS 4 IU VH S/D (Fibrin Sealant With 4IU/mL Thrombin, Vapor Heated, Solvent/Detergent Treated) to Adhere Split Thickness Skin Grafts and Improve Wound Healing in Burn Patients
The primary objective of this study is to evaluate skin graft adherence and wound healing in burn patients to evaluate whether FS 4IU VH S/D is equivalent or superior to the current standard of care (staples).
- Trial name
- NCT00157131
- Testing
- Fibrin Sealant, ARTISS 4IU/ml VH SD, Staples
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Baxter Healthcare Corporation
Thrombin Inhibition
Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
- Trial name
- NCT01150812
- Testing
- AZD8165
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Atherosclerosis, Ischemia
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)
The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis…
- Conditions
- Atherosclerosis, Ischemia, Myocardial Infarction, Cerebrovascular Accident
- Trial name
- NCT00526474
- Testing
- Vorapaxar
- Volunteers
- 26,449 people
- Sponsor
- Merck Sharp & Dohme LLC
Blood Coagulation
Observational Study Assessing the Impact of Exposure to THROMBIN-JMI® on Coagulation Parameters.
The purpose of this study is to assess the effect of possible exposure to THROMBIN JMI® on activated partial thromboplastin time (aPTT) at 48 hours post surgery in subjects with likelihood of prior exposure to THROMBIN JMI®…
- Trial name
- MOSAIC (NCT00775398)
- Where
- 43 sites in United States
- Volunteers
- 553 people
- Sponsor
- Pfizer
Arthroplasty, Replacement, Prevention of Venous Thromboembolism
Treatment of Patients Undergoing Primary Unilateral Elective Total Knee or Hip Replacement With Dabigatran Etexilate
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip…
- Conditions
- Arthroplasty, Replacement, Prevention of Venous Thromboembolism, Moderate Renal Impairment (CrCl 30-50 mL/Min)
- Trial name
- NCT01184989
- Testing
- Dabigatran etexilate
- Where
- 10 sites in Austria, Canada and 4 more
- Volunteers
- 142 people
- Sponsor
- Boehringer Ingelheim
Factor V Leiden, Factor II
Determination of Performance Characteristics of the MassPLEX Factor II/V Leiden Test
To establish the overall agreement of the MassPLEX Factor II and Factor V Leiden Genotyping Test with bi-directional DNA sequencing for Factor II and Factor V Leiden.
- Conditions
- Factor V Leiden, Factor II, Thrombosis
- Trial name
- NCT01835483
- Where
- 3 sites in United States
- Volunteers
- 867 people
- Sponsor
- Sequenom, Inc.
Thrombin-specific Anticoagulant Bivalirudin During Percutaneous Coronary Intervention (PCI)
ImproveR International (BI-001-IM)
The objectives of this registry are to assess the use of the thrombin-specific anticoagulant bivalirudin during percutaneous coronary intervention (PCI) in a real life setting.
- Trial name
- NCT00290849
- Testing
- Bivalirudin
- Where
- Denmark
- Volunteers
- 4,000 people
- Sponsor
- Nycomed
Blood Loss, Surgical
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
- Trial name
- NCT00813904
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- ZymoGenetics
Hemoptysis
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
This is a multi-centre, randomised, double blind, placebo controlled clinical study which is designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to severe hemoptysis.
- Trial name
- NCT03270735
- Testing
- Snake venom thrombin (Treatment)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Lee's Pharmaceutical Limited