NCT07333144 Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants
| NCT ID | NCT07333144 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Gastrointestinal Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2025-02-28 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07333144 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07333144 currently recruiting?
Yes, NCT07333144 is actively recruiting participants. Contact the research team at valerie.wilme@chru-strasbourg.fr for enrollment information.
Where is the NCT07333144 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07333144 clinical trial?
NCT07333144 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 250 participants.