Clinical trials: High Bleeding Risk Patients
Atrial Fibrillation, Anticoagulants and Bleeding Disorders
Left Atrial Appendage Occlusion for AF Patients Unable to Use Oral Anticoagulation Therapy
Up to 5% of Atrial Fibrillation (AF) patients may have or develop contraindications to use oral anticoagulation (OAC). Randomized controlled trial (RCT) data suggest that Left Atrial Appendage Occlusion (LAAO) may provide a…
- Trial name
- COMPARE-LAAO (NCT04676880)
- Testing
- Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)
- Where
- 14 sites in Netherlands
- Volunteers
- 609 people
- Sponsor
- R&D Cardiologie
Stable Angina, Ischemic Heart Disease Silent
A Randomized Clinical Evaluation of the BioFreedom™ Stent
The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and…
- Conditions
- Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction, In-stent Coronary Artery Restenosis
- Trial name
- Leaders Free (NCT01623180)
- Testing
- Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
- Where
- Switzerland
- Volunteers
- 2,456 people
- Sponsor
- Biosensors Europe SA
Peptic Ulcer Hemorrhage
Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients
The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed…
- Trial name
- Eso_1y_R6PUB (NCT02456012)
- Testing
- oral esomeprazole 20 mg twice daily, oral esomeprazole 20 mg once daily
- Where
- Taiwan
- Volunteers
- 268 people
- Sponsor
- Hsiu-Chi Cheng
Early Gastric Cancer, Gastric Adenoma
Fibrin Glue After ESD for High Risk Patients of Bleeding
It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.
- Trial name
- NCT04602689
- Testing
- Human fibrinogen concentrate
- Where
- South Korea
- Volunteers
- 134 people
- Sponsor
- Seoul National University Hospital
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.
Intracranial Aneurysms, Subarachnoid Hemorrhage, Aneurysmal
Screening in Relatives With Elevated Risk for Unruptured Intracranial Aneurysms
The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms.
- Trial name
- SIREN (NCT07387575)
- Where
- Serbia
- Volunteers
- 300 people
- Sponsor
- University of Novi Sad
Blood Loss, Surgical, Blood Loss, Postoperative
Prophylactic Intravenous Calcium Gluconate to Decrease Blood Loss at Time of Cesarean Delivery in Pregnant Patients at High Risk for Uterine Atony
This research study is being done to learn what effect a single dose of calcium gluconate will have on blood loss at the time of cesarean delivery in pregnancy patients at high risk for uterine atony.
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative, Uterine Atony
- Trial name
- NCT07217899
- Testing
- Calcium Gluconate, Saline
- Where
- United States
- Volunteers
- 140 people
- Sponsor
- University of Michigan
Pulmonary Embolism Subacute Massive, Thrombolytic Therapy
Effect of Thrombolysis on 30-day Mortality in Intermediate High Risk Pulmonary Patients With Low Bleeding Risk
The aim of investigators was to study the effect and safety of Thrombolysis in Intermediate high risk pulmonary embolism patients with low bleeding risk as regards Mortality and bleeding events.
- Trial name
- NCT07374978
- Testing
- Thrombolytic therapy for the study group in the form of streptokinase or recombinant tissue plasminogen activator, Unfractionated Heparin IV
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Ain Shams University
Coronary Disease, Heart Diseases
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Antiphospholipid Syndrome (APS), Direct Oral Anticoagulants (DOACs)
OBServaToIre interNational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
This registry will make it possible to collect large-scale data on SAPL patients, particularly those treated with DOACs, in order to better assess the frequency of thrombotic and hemorrhagic events in this population of…
- Conditions
- Antiphospholipid Syndrome (APS), Direct Oral Anticoagulants (DOACs), Thrombotic and Bleeding Events, Safety
- Trial name
- OBSTINATE 2 (NCT06929182)
- Testing
- "non-high risk" thrombotic APS patients treated with DOAC
- Where
- Spain
- Volunteers
- 500 people
- Sponsor
- Central Hospital, Nancy, France
Hemoptysis
Urokinase Like Plasminogen Activator Levels in Patients Undergoing Bronchoscopy
Some of the risk factors for bleeding following bronchoscopy is having a malignancy or an immunocompromised state. The etiology of this remains uncertain.
- Trial name
- NCT00929565
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Oklahoma
Obesity, Morbid, Obesity
CiNPT for Abdominoplasties in Post-bariatric Patients Study
The overarching goal of this research is to assess whether the post-operative use of closed-incision Negative Pressure Therapy (ciNPT) accelerates healing of surgical wounds, improves surgical outcomes, and reduces the rate of…
- Conditions
- Obesity, Morbid, Obesity, Obesity, Abdominal, Wound
- Trial name
- CAPS (NCT04214236)
- Testing
- ciNPT group, Control group
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliera, Ospedale Civile di Legnano
Gastroesophageal Varices
EUS-guided Glue Injection for Varices Study
Bleeding from gastroesophageal varices is one of the major complications of cirrhosis. After successful treatment of the acute bleeding episode, patients who do not receive follow-up treatment to prevent rebleeding were reported…
- Trial name
- NCT02672319
- Testing
- EUS-guided glue injection
- Where
- Hong Kong
- Volunteers
- 30 people
- Sponsor
- Chinese University of Hong Kong
Coronary Stenosis
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding.
- Trial name
- NCT03877848
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- Israel
- Volunteers
- 319 people
- Sponsor
- Medinol Ltd.
Abdominal Aortic Aneurism, Abdominal Aortic Rupture
Haemostasis Management of Abdominal Aortic Procedures
Comparative study on efficacy of haemostatic therapy guided either by standard laboratory coagulation parameters or point-of-care testing in patients undergoing vascular surgical procedures.
- Conditions
- Abdominal Aortic Aneurism, Abdominal Aortic Rupture, Perioperative/Postoperative Complications, Surgical Blood Loss
- Trial name
- NCT03426839
- Testing
- Coagulation tests
- Volunteers
- 40 people
- Sponsor
- University of Pecs
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
Postpartum Hemorrhage
Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH
The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child…
- Trial name
- NCT02604719
- Testing
- Tranexamic Acid and Ethamsylate
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Ahmed Alanwar