Pilot Study and Registry on Restarting Direct Oral Anticoagulants After Major Gastrointestinal Bleeding in Patients at Moderate to High Risk

What this Trial Is About

Researchers are studying the safety of restarting direct oral anticoagulants DOACs after a major gastrointestinal GI bleeding event in patients who have a moderate to high risk of bleeding again or developing blood clots. This pilot study aims to evaluate a standardized plan for resuming DOACs based on the patients risk of clotting, helping to guide treatment decisions. A parallel registry will also compare patients who participate in the study with those who do not to understand any differences and explore challenges in enrolling patients. The study divides patients into two groups based on their thrombotic risk. Patients at high thrombotic risk will restart DOACs within 7 days after clinical hemostasis following GI bleeding. Those at moderate thrombotic risk will restart DOACs between 7 and 14 days after clinical hemostasis. The exact timing is determined by the clinical care team, and the type and dose of DOACs are chosen by the patient and their physician. No placebo or randomization is involved in this study. Participants will be monitored for 18 months to assess recruitment and adherence rates. During the study, researchers will evaluate outcomes such as repeat endoscopy, hospital readmissions, bleeding events, stroke, embolism, venous thromboembolism, mortality, functional status, and quality of life within 90 days after resuming DOACs. The study involves regular follow-up exams and data collection to assess these safety and clinical outcomes over time.

Anticoagulation After GI Bleeding Pilot Study and Registry