Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants

Gastrointestinal bleeding (GIB) is a common emergency in hepatology and gastroenterology, with an overall mortality rate ranging from 5% to 10% depending on the study. GIB is classified into two categories: upper GIB (80% of cases) and lower GIB (20% of cases). There are many risk factors for GIB, including anticoagulants. In cases of GD under anticoagulants, there are specific management recommendations. In particular, in cases of severe bleeding under direct oral anticoagulants (DOACs), it is recommended to stop treatment and correct coagulation parameters according to the severity of the bleeding and the associated thrombotic risk. Various treatments can be used for this purpose, including specific antidotes, fresh frozen plasma, and prothrombin complex concentrate (PCC). However, the role of PCC in this indication is uncertain, as is the efficacy and safety data for this drug, due to significant methodological limitations in the few studies conducted on the subject.

NCT Number	NCT07333144
Lead Sponsor	University Hospital, Strasbourg, France
Conditions	Gastrointestinal Bleeding
Enrollment	250 participants
Start Date	2025-02-28
Primary Completion	2026-06 (estimated)
Study Completion	2026-06-28 (estimated)
Updated on ClinicalTrials.gov	2026-01-12