Clinical trials: High Bleeding Risk Patients
Coronary Artery Disease
Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon
Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk.
- Trial name
- ULTIMATE-III (NCT04255043)
- Testing
- IVUS guidance, Angiography guidance
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Chronic Subdural Hematoma, At Risk of Post-operative Recurrence
Embolization of the Middle Meningeal Artery for the Prevention of Chronic Subdural Hematoma Recurrence in High Risk Patients (EMPROTECT)
Standard of care for the management of symptomatic chronic subdural hematomas (SDHs) is neurosurgical burr-hole evacuation followed by drainage. Post-operative recurrence rates may be as high as 10 to 20 %.
- Conditions
- Chronic Subdural Hematoma, At Risk of Post-operative Recurrence, Burr-hole Surgery
- Trial name
- EMPROTECT (NCT04372147)
- Testing
- MMA embolization
- Where
- 12 sites in France
- Volunteers
- 342 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Ulcer Bleeding
Second-look Endoscopy in High Risk Patients After Endoscopic Hemostasis to Their Bleeding Peptic Ulcers Improves Their Outcomes
Bleeding peptic ulcer is a common medical emergency. Endoscopic treatment stops bleeding in those actively bleeding from their peptic ulcers, reduces further bleeding, transfusion, surgery and deaths.
- Trial name
- NCT02352155
- Testing
- epinephrine injection or heater probe or hemoclips, Observation only
- Where
- 2 sites in China, Thailand
- Volunteers
- 157 people
- Sponsor
- Chinese University of Hong Kong
Coronary Artery Disease
Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex…
- Trial name
- NCT04138238
- Testing
- Supraflex Cruz Sirolimus-eluting Stent
- Where
- 26 sites in France, Germany and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Sahajanand Medical Technologies Limited
Carotid Artery Diseases
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
The optimal duration of dual antiplatelet therapy (DAPT) after carotid artery stenting (CAS) in patients at high bleeding risk (HBR) has not been established in randomized controlled trials.
- Trial name
- NCT06276374
- Testing
- Intervention 1(DAPT): Drug: Aspirin 100mg + Clopidogrel 75mg. Intervention 2(SAPT): Drug: Asprin 100mg or Clopidogrel 75mg
- Where
- South Korea
- Volunteers
- 1,556 people
- Sponsor
- Woo-Keun Seo
Atrial Fibrillation
High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France
This study is a retrospective analysis of observational cohorts using data from prospectively collected administrative/claims data to investigate treatment patterns, and safety and effectiveness outcomes in patients with NVAF…
- Trial name
- HELIOS-AF (NCT05038228)
- Testing
- Apixaban, Rivaroxaban, Dabigatran
- Where
- United Kingdom
- Volunteers
- 1 people
- Sponsor
- Pfizer
Hematuria, Urothelial Carcinoma
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
- Trial name
- DRIVE (NCT04943380)
- Testing
- Cxbladder
- Where
- 10 sites in United States
- Volunteers
- 682 people
- Sponsor
- Pacific Edge Limited
Coronary Artery Disease
Drug-Coated Balloon in Patients With High Bleeding Risk
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of…
- Trial name
- DCB-HBR (NCT05221931)
- Testing
- Percutaneous coronary intervention
- Where
- 17 sites in South Korea
- Volunteers
- 1,359 people
- Sponsor
- Samsung Medical Center
Gastrointestinal Hemorrhage
Predictive Role of Red Cell Distribution Width in Upper GI Bleeding Patients
Acute upper-gastrointestinal bleeding (UGIB) is a commonly encountered cause of admission in emergency department (ED). Early risk stratification allows appropriate therapy that may be helpful to advance the patient's morbidity…
- Trial name
- NCT03119987
- Testing
- Red cell distribution widths
- Volunteers
- 400 people
- Sponsor
- Konkuk University Medical Center
Non-ST-elevation Acute Coronary Syndrome, Unstable Angina
Ticagrelor or Prasugrel Versus Clopidogrel in Elderly Patients With an Acute Coronary Syndrome and a High Bleeding Risk: Optimization of Antiplatelet Treatment in High-risk Elderly
A randomized controlled, open label, multicenter trial with 1000 patients aged 70 years and older, presenting with Non-ST-elevation acute coronary syndrome.
- Conditions
- Non-ST-elevation Acute Coronary Syndrome, Unstable Angina, Non-ST-elevation Myocardial Infarction
- Trial name
- POPular AGE (NCT02317198)
- Testing
- Clopidogrel, Ticagrelor or Prasugrel
- Where
- Netherlands
- Volunteers
- 1,011 people
- Sponsor
- St. Antonius Hospital
High Bleeding Risk Patients, Cardiology
Dual Anti-Platelet Optimized Stent for High Bleeding Risk Patient
High risk of bleeding (HBR) is a determining factor for the duration of dual antiplatelet therapy (DAPT). Recent studies have shown that the use of one-month DAPT is beneficial in terms of ischemic as well as hemorrhagic events…
- Conditions
- High Bleeding Risk Patients, Cardiology, Stent Implantation, DAPT(Dual Antiplatelet Therapy)
- Trial name
- DIOHR (NCT07140133)
- Where
- France
- Volunteers
- 1,200 people
- Sponsor
- University Hospital, Grenoble
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
Hemorrhage
Pre-emptive Hemodynamic Optimization of High Risk Patients Undergoing Elective Major Surgical Procedures
Several recent clinical trials have documented that early aggressive resuscitation approached guided by defined hemodynamic variables using thoughtful protocols may improve outcome.
- Trial name
- NCT00725972
- Testing
- Augment O2 Delivery by hemodynamic protocol, High Risk Surgery
- Where
- United States
- Sponsor
- University of Pittsburgh
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
Coronary Artery Disease, Acute Coronary Syndrome
Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT
Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk.
- Trial name
- POEM (NCT03112707)
- Testing
- Aspirin, P2Y12 inhibitor
- Where
- Italy
- Volunteers
- 1,023 people
- Sponsor
- Humanitas Hospital, Italy
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
Bleeding After GI Endoscopy
Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Controlled Trial
Background： Colonoscopy can detect colon polyps and perform excision to the polyps to prevent colon cancer. However, delayed polypectomy bleeding is one of the complications to be noticed, which has an occurrence rate of about…
- Trial name
- NCT07257926
- Testing
- Sucralfate, Clip
- Volunteers
- 160 people
- Sponsor
- National Cheng-Kung University Hospital
Postpartum Hemorrhage, Uterine Atony
Oxytocin Bolus Versus Infusion in High-Risk Patients Undergoing Elective Cesarean Section (INBOX-HR)
The goal of this randomized, double-blind clinical trial is to learn if Oxytocin is most effective at achieving adequate uterine tone (important for preventing postpartum hemorrhage) when administered as a bolus or an infusion in…
- Conditions
- Postpartum Hemorrhage, Uterine Atony, Uterine Atony With Hemorrhage, Elective Cesarean Section
- Trial name
- INBOX-HR (NCT07688512)
- Testing
- Oxytocin Bolus or Oxytocin Infusion
- Volunteers
- 180 people
- Sponsor
- Stony Brook University
Proliferative Diabetic Retinopathy - High Risk
Immediate Postoperative Bevacizumab Administration in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy
Patients undergoing surgery for complications related to diabetes will be recruited.
- Trial name
- Postop IVA (NCT06899529)
- Testing
- Bevacizumab
- Where
- Mexico
- Volunteers
- 150 people
- Sponsor
- Christian Ophthalmic Surgery Expedition Network
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