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

December 30, 2025 updated by: University Hospital, Strasbourg, France

Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants: Analysis of Reversal Practices Using Prothrombin Complex at the Strasbourg University Hospitals

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service des Urgences Adultes - CHU de Strasbourg - France
        • Sub-Investigator:
          • François SEVERAC, Statistician
        • Contact:
        • Principal Investigator:
          • Valérie WILME, MD
        • Sub-Investigator:
          • Julien LE BLOAS, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients on direct oral anticoagulants admitted to the emergency department of Strasbourg University Hospital
Time Frame: 48 hours following patient admission
Proportion of patients on direct oral anticoagulants admitted to the emergency department of Strasbourg University Hospital for gastrointestinal bleeding who received prothrombin complex concentrate within the first 48 hours of admission.
48 hours following patient admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 28, 2026

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9612

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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