Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants

NCT07333144 | Recruiting

• 1 other identifier: 9612
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Bleeding

Keywords

Gastrointestinal bleeding; Hepatogastroenterology; Direct oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on direct oral anticoagulants admitted to the emergency department of Strasbourg University Hospital

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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 may not qualify if:

• Subject who has expressed their objection to the reuse of their data for scientific research purposes.
• Subject under guardianship, curatorship, or legal protection.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service des Urgences Adultes - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valérie WILME, MD

CONTACT

33 3 88 11 67 68; valerie.wilme@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: February 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

FR (1)