Clinical trials: High Bleeding Risk
Coronary Artery Disease, High Bleeding Risk Patients
ULTRA LONG: BioFreedom Ultra
The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk…
- Trial name
- NCT05643430
- Testing
- BioFreedom Ultra
- Where
- 9 sites in France, United Kingdom
- Volunteers
- 86 people
- Sponsor
- Biosensors Europe SA
Cardiac Death, Myocardial Infarction
Leaders Free III: BioFreedom™ Clinical Trial
A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding
- Conditions
- Cardiac Death, Myocardial Infarction, Stent Thrombosis, Bleeding
- Trial name
- NCT03118895
- Testing
- BioFreedom™ BA9™ drug-coated stent
- Where
- 2 sites in France, Switzerland
- Volunteers
- 404 people
- Sponsor
- Biosensors Europe SA
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Venous Thromboembolism
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs)…
- Trial name
- NCT05819125
- Where
- United States
- Volunteers
- 21,000 people
- Sponsor
- Sanofi
Bloodloss, Surgical Procedures, Operative
Outcomes and Safety Trial Investigating Ecallantide's Effect on Reducing Surgical Blood Loss Volume in Subjects at High Risk of Bleeding Exposed to Cardio-pulmonary Bypass During Cardiac Surgery
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
- Trial name
- CONSERV-2 (NCT00888940)
- Testing
- Ecallantide, Cyklokapron(R)
- Where
- 34 sites in United States, Germany and 1 more
- Volunteers
- 243 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Non-Valvular Atrial Fibrillation
Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk
The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial…
- Trial name
- Omega (NCT04829929)
- Testing
- Omega™LAA Occluder implantation
- Where
- 13 sites in Denmark, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Eclipse Medical Ltd.
Coronary Artery Disease
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month DAPT treatment receiving…
- Trial name
- Onyx ONE (NCT03344653)
- Testing
- Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Biosensors BioFreedom BA9 Drug Coated Coronary Stent
- Where
- 89 sites in Australia, Austria and 21 more
- Volunteers
- 2,000 people
- Sponsor
- Medtronic Vascular
Bleeding Disorder, Stroke, Ischemic
XIENCE 28 Global Study
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of…
- Conditions
- Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease
- Trial name
- NCT03355742
- Testing
- XIENCE, DAPT
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 963 people
- Sponsor
- Abbott Medical Devices
Acute Gastrointestinal Bleeding
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
A prospective, multi-center, noninferiority randomized controlled trial designed to compare the efficacy of UI-EWD (Nexpowder™) hemostatic powder versus conventional endoscopic hemostatic therapy in patients presenting with acute…
- Trial name
- TREET (NCT06188585)
- Testing
- UI-EWD, Conventional therapy
- Where
- 14 sites in United States, Canada and 4 more
- Volunteers
- 278 people
- Sponsor
- Medtronic - MITG
Post Partum Haemorrhage, Maternal Care Patterns
Pivotal, Prospective, Multi-centre, Single-arm Study to Evaluate the Safety and Effectiveness of Oli for Identification of Patients, During the Intrapartum Period, Who Are at Higher Risk of Developing Abnormal Postpartum Uterine Bleeding, Including Postpartum Haemorrhage
Oli is a predictive, non-invasive device, intended to be placed on the participant's maternal abdomen during the intrapartum period, which can alert healthcare professionals of an impending cumulative blood loss of ≥500 ml…
- Conditions
- Post Partum Haemorrhage, Maternal Care Patterns, High Risk Pregnancy
- Trial name
- NCT06655207
- Testing
- Oli is a non-invasive, wearable device, designed to provide clinicians with an early indication if the participant is at a higher risk of developing abnormal postpartum uterine bleeding
- Where
- 7 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- Baymatob Operations Pty Ltd
Acute Kidney Injury
Nafamostat Efficacy in Phase 3 Registrational CRRT Study
A prospective, randomized, placebo-controlled clinical study to investigate the safety and efficacy of Niyad (nafamostat mesylate) for anticoagulation of extracorporeal blood circulating through a dialysis filter in patients…
- Trial name
- NEPHRO (NCT06150742)
- Testing
- Niyad (nafamostat mesylate)
- Where
- 10 sites in United States
- Volunteers
- 70 people
- Sponsor
- Talphera, Inc
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Non-valvular Atrial Fibrillation
Safety and Effectiveness of Apixaban Compared to Warfarin in Patients With Non-valvular Atrial Fibrillation (a Type of Irregular Heart Rhythm) at Higher Chance of Bleeding
The purpose of this study is to compare effectiveness and safety of warfarin and apixaban among non-valvular atrial fibrillation (NVAF) patients at higher chance of bleeding using a Japanese nation-wide administrative claims…
- Trial name
- NCT05471505
- Where
- Japan
- Volunteers
- 120,722 people
- Sponsor
- Pfizer