Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants (HEMOD-AOD)

University Hospital, Strasbourg, France

Status: Enrolling

Conditions: Gastrointestinal Bleeding

Study type: Observational

Funder types: Other

Identifiers

NCT07333144

9612

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patient (≥ 18 years)
• Male or female
• Patient admitted to the emergency department for gastrointestinal bleeding (hematemesis, melena, rectal bleeding, or hematochezia)
• Taking a direct oral anticoagulant (dabigatran, apixaban, or rivaroxaban)

Exclusion criteria

• Subject who has expressed their objection to the reuse of their data for scientific research purposes.
• Subject under guardianship, curatorship, or legal protection.