Managing gastrointestinal bleeding in people taking direct oral anticoagulants
Official title: Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants: Analysis of Reversal Practices Using Prothrombin Complex at the Strasbourg University Hospitals
Run by University Hospital, Strasbourg, France · NCT07333144 · Data updated 2026-11-12
This project will see how doctors treat gastrointestinal bleeding in adults on direct oral anticoagulants and whether giving prothrombin complex concentrate (PCC) appears helpful and safe.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | February 28, 2025 |
| Main results expected | June 2026 |
| Study ends | June 28, 2026 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07333144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) who present to the CHU Strasbourg adult emergency department with gastrointestinal bleeding and who are taking a direct oral anticoagulant (dabigatran, apixaban, or rivaroxaban) and have not objected to reuse of their data are eligible.
✕Probably not a fit
People not taking DOACs (for example on warfarin), children, patients under legal guardianship or curatorship, and those who refuse data reuse are unlikely to benefit from this study's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study enrolls adults admitted to the emergency department at the University Hospital of Strasbourg with upper or lower gastrointestinal bleeding who are taking a direct oral anticoagulant (dabigatran, apixaban, or rivaroxaban). Investigators will collect clinical data on anticoagulant interruption, coagulation correction measures (including PCC, specific antidotes, and fresh frozen plasma), bleeding severity, and thrombotic risk without changing routine care. The project aims to describe real-world management patterns and gather safety and outcome data related to PCC use. As prior evidence is limited and methodologically heterogeneous, this single-center registry is intended to clarify current practice and generate hypotheses for future trials.
Why it matters
Potential benefit: If successful, the study could clarify whether PCC is a safe and effective option for reversing DOAC-related bleeding and help clinicians choose treatments that reduce complications and mortality.
How similar studies have gone: Existing studies on PCC for DOAC-associated bleeding are few, methodologically limited, and give mixed or inconclusive results, so the approach is not yet well proven.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Service des Urgences Adultes - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Valérie WILME, MD
- Email: valerie.wilme@chru-strasbourg.fr
- Phone: 33 3 88 11 67 68
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.