Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07333144

Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service des Urgences Adultes - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

François SÉVERAC, Statistician

SUB_INVESTIGATOR

Julien LE BLOAS, MD

SUB_INVESTIGATOR

Valérie WILME, MD

CONTACT

[email protected]

33 3 88 11 67 68

Valérie WILME, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Valérie WILME, MD

CONTACT

[email protected]

33 3 88 11 67 68

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: HEMOD-AOD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.