Clinical trials: Anticoagulants and Bleeding Disorders
Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage
Anticoagulation With Enhanced Gastrointestinal Safety
This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization (defined as either discontinuation of all…
- Conditions
- Upper Gastrointestinal Bleeding, Peptic Ulcer Hemorrhage, Anticoagulant-induced Bleeding
- Trial name
- AEGIS (NCT05563714)
- Testing
- Clinician Notification with Nurse Facilitation (CNNF), Wait list control
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- University of Michigan
Atrial Fibrillation, Stroke
Rivaroxaban vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation
This prospective, randomized, active-controlled, parallel arm study compares the safety and financial benefits of arterial thromboembolism prophylaxis with Warfarin vs.
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- NEW-AF (NCT03702582)
- Testing
- Rivaroxaban, Warfarin
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Massachusetts General Hospital
Venous Thromboembolism, Deep Venous Thrombosis
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus, Reconstructive Surgery
- Trial name
- NCT03212365
- Testing
- Fixed dose, Variable dose
- Where
- 2 sites in United States
- Volunteers
- 295 people
- Sponsor
- University of Utah
Arterial Occlusion, Cardiovascular Diseases
Comparing TR Band to Statseal in Conjunction With TR Band II
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures.
- Conditions
- Arterial Occlusion, Cardiovascular Diseases, Atherosclerosis, Hematoma
- Trial name
- Statseal II (NCT04046952)
- Testing
- Statseal with TR Band, TR band only
- Where
- United States
- Volunteers
- 443 people
- Sponsor
- VA Long Beach Healthcare System
Reversal of Coagulopathy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
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 vitamin K antagonists in subjects who require…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring
Acute Intracranial Hemorrhage
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
- Trial name
- NCT03661528
- Testing
- andexanet alfa, Usual Care
- Where
- 142 sites in United States, Austria and 22 more
- Volunteers
- 530 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
Acute Hypoxemic Respiratory Failure, Anticoagulant-induced Bleeding
Strategies for Anticoagulation During Venovenous ECMO
Moderate intensity titrated dose anticoagulation has been used in patients receiving extracorporeal membrane oxygenation (ECMO) to prevent thromboembolism and thrombotic mechanical complications.
- Conditions
- Acute Hypoxemic Respiratory Failure, Anticoagulant-induced Bleeding, Thromboembolism
- Trial name
- SAFE-ECMO (NCT04997265)
- Testing
- Low intensity anticoagulation, Moderate Intensity Anticoagulation
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Vanderbilt University Medical Center
Anticoagulants and Bleeding Disorders, Surgery
Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin
The main objective of this study is to determine the time interval following the last treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less than 0.2 international unit per milliliter (IU/mL)…
- Conditions
- Anticoagulants and Bleeding Disorders, Surgery, Regional Anesthesia Morbidity
- Trial name
- NCT03296033
- Testing
- Enoxaparin
- Where
- United States
- Volunteers
- 122 people
- Sponsor
- Wake Forest University Health Sciences
Venous Thromboembolism
Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
This study is a retrospective, observational, nationwide population-based cohort study utilizing the South Korea's Health Insurance and Review Assessment Service (HIRA) database.
- Trial name
- NCT05022563
- Testing
- Parenteral anticoagulant, Warfarin, Apixaban
- Where
- 2 sites in South Korea
- Volunteers
- 55,759 people
- Sponsor
- Pfizer
Osteoarthritis of the Knee, Coagulopathy
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic…
- Trial name
- ATCCTCP-1 (NCT01511939)
- Testing
- Pennsaid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Nathan Wei, MD, FACP, FACR:
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
Left Sided Heart Failure, Left Ventricular Assist Device
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD].
- Conditions
- Left Sided Heart Failure, Left Ventricular Assist Device, Anticoagulant Therapy, Gastro Intestinal Bleeding
- Trial name
- VAD-ANTIX (NCT03143569)
- Testing
- aPTT guided heparin management, Anti-factor Xa guided heparin management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Coronary Artery Disease, Ischemic Heart Disease
The Randomized OPTIMAL-ACT Trial
The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding, Coronary Syndrome
- Trial name
- NCT03772613
- Testing
- Unfractionated heparin
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Mayo Clinic
Reversal of Anticoagulant Treatment
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
- Trial name
- NCT00618098
- Testing
- Octaplex (human prothrombin complex concentrate), Fresh frozen plasma
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Octapharma
Healthy Volunteers
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Health Volunteers
Background: Rivaroxaban and apixaban are blood thinners. People with HIV may need to take them to treat or prevent blood clots. The anti-HIV drug darunavir (DRV) can increase the amount of these blood thinners in the body.
- Trial name
- NCT03864406
- Testing
- Cobicistat, Darunavir/Cobicistat, Rivaroxaban
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
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
Arterial Occlusion, Angina Pectoris
Comparing TR Band to Statseal in Conjunction With TR Band
The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural…
- Conditions
- Arterial Occlusion, Angina Pectoris, Cardiovascular Diseases, Atherosclerosis
- Trial name
- NCT03028025
- Testing
- StatSeal, TR Band
- Where
- United States
- Volunteers
- 184 people
- Sponsor
- VA Long Beach Healthcare System