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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Service des Urgences Adultes - CHU de Strasbourg - France
Strasbourg, France
Start Date
February 28, 2025
Primary Completion Date
June 1, 2026
Completion Date
June 28, 2026
Last Updated
January 12, 2026
250
ESTIMATED participants
Lead Sponsor
University Hospital, Strasbourg, France
NCT07261228
NCT06515353
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