Actively Recruiting
Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants: Analysis of Reversal Practices Using Prothrombin Complex at Strasbourg University Hospitals
Led by University Hospital, Strasbourg, France · Updated on 2026-01-12
250
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastrointestinal bleeding (GIB) is a frequent emergency in liver and digestive health, with death rates between 5% and 10% depending on the study. GIB is divided into upper GIB and lower GIB, with upper cases making up 80%. Many factors increase the risk of GIB, including the use of blood thinners called direct oral anticoagulants (DOACs). When severe bleeding occurs under these medications, current guidelines recommend stopping the treatment and correcting blood clotting based on bleeding severity and clotting risk. However, the role, safety, and effectiveness of prothrombin complex concentrate (PCC) in this situation is uncertain due to limited research. This observational study analyzes how reversal treatments like PCC are used in patients with gastrointestinal bleeding who are taking DOACs. It focuses on patients admitted to the emergency department of Strasbourg University Hospital. The study tracks patients over 48 hours following admission to document treatment practices and outcomes without introducing new treatments or randomization. Participants will be monitored closely during their emergency department stay, with data collected on their bleeding management and anticoagulant reversal methods. Researchers will measure the proportion of patients on DOACs admitted for gastrointestinal bleeding and observe how coagulation is corrected. This will help understand current practices and outcomes related to PCC use and other treatments in this critical setting. The study runs until June 2026 and does not involve experimental interventions or placebo.
CONDITIONS
Brief Title
Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- Subject who has expressed their objection to the reuse of their data for scientific research purposes.
- Subject under guardianship, curatorship, or legal protection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 48 hours following patient admission
Participants who undergo routine care are observed for gastrointestinal bleeding while on direct oral anticoagulants.
1 to 2 visits depending on patient status
Trial Site Locations
Total: 1 location
1
Service des Urgences Adultes - CHU de Strasbourg - France
Strasbourg, France, 67091
Actively Recruiting
Research Team
V
Valérie WILME, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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