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
Acute Major Bleeding, Reversal of Coagulopathy
Study of a Prothrombin Complex Concentrate for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Japanese Subjects
The purpose of this study is to evaluate efficacy and safety of a Prothrombin Complex Concentrate (PCC), BE1116. BE1116 will be used for the rapid reversal of coagulopathy induced by vitamin K antagonists in Japanese subjects who…
- Trial name
- NCT02281201
- Testing
- BE1116 (Prothrombin Complex Concentrate)
- Where
- 11 sites in Japan
- Volunteers
- 11 people
- Sponsor
- CSL Behring
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
Acute Major Bleeding
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate…
- Trial name
- NCT04867837
- Testing
- Octaplex
- Where
- 63 sites in United States, Austria and 11 more
- Volunteers
- 100 people
- Sponsor
- Octapharma
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.
Hepatic Failure, Liver Failure
Cardiox Liver Function Test Pivotal Trial
Performance evaluation of LFT Dye Monitor System using ICG - plasma disappearance rate value (PDR) to assess liver function in normal patients as well as in patients with mild to severe hepatic impairment compared to manual Serum…
- Trial name
- LFT-0002 (NCT02552901)
- Testing
- 0.1 mg/kg ICG Dose, 0.5 mg/kg ICG dose
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Cardiox Corporation
Chronic Disease, Endocrine System Disease
Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways
This observation will look at patient care decisions of the primary healthcare provider utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9, 2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1.
- Conditions
- Chronic Disease, Endocrine System Disease, Cardiovascular Disease, Respiratory Tract Disease
- Trial name
- NCT02525887
- Testing
- Observation
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Bracane Company
Healthy
A Study to Assess the Effects of 2 Different Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban in Healthy Adult Volunteers
The purpose of this study is to assess the use of 2 different Prothrombin Complex Concentrates (PCCs) on their ability to reverse (normalize) the pharmacodynamic effects of rivaroxaban in healthy adult volunteers.
- Trial name
- NCT01656330
- Testing
- Rivaroxaban 20 mg twice daily, Rivaroxaban 20 mg once daily, Profilnine SD
- Where
- Belgium
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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
Factor V Leiden, Prothrombin G20210A
A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism
This is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of…
- Conditions
- Factor V Leiden, Prothrombin G20210A, Venous Thromboembolism (VTE)
- Trial name
- NCT07430397
- Testing
- CITY-FXI
- Where
- United Kingdom
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Healthy Volunteers
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact.
- Trial name
- NCT05205863
- Testing
- Cofact
- Where
- Netherlands
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Prothya Biosolutions
Healthy
A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume)…
- Trial name
- NCT02561923
- Testing
- Rivaroxaban, Tranexamic acid, Kcentra, a 4-factor PCC
- Where
- United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Janssen Scientific Affairs, LLC
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
Cardiovascular, Neurologic (Spine), and General Surgery
A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery
The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.
- Trial name
- NCT00196534
- Testing
- Human Thrombin, Bovine Thrombin
- Where
- 17 sites in United States
- Volunteers
- 304 people
- Sponsor
- Ethicon, Inc.
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.
Atrial Fibrillation, Pulmonary Embolism
Blood Donation From Warfarin Users for the Development of POC INR Monitor
This study is to further develop and optimise the design and manufacturing process of a handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy.
- Conditions
- Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis
- Trial name
- NCT02355730
- Testing
- Venepuncture
- Where
- United Kingdom
- Volunteers
- 1,560 people
- Sponsor
- Microvisk Technologies Ltd
Clotting Disorders
Study to Determine the Accuracy of Prothrombin Time of Warfarinised Blood
The purpose of this study is to measure prothrombin time (PT) expressed in International Normalised Ratio (INR) units in persons receiving coumadin (warfarin) treatment on an experimental device and a commercially available…
- Trial name
- NCT01375725
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Universal Biosensors Pty Ltd