Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants
ConditionGastrointestinal Bleeding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Subject who has expressed their objection to the reuse of their data for scientific research purposes.
Subject under guardianship, curatorship, or legal protection.
Trial 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)
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
48 hours following patient admissionSponsors and contacts
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Source ClinicalTrials.gov