Management of Gastrointestinal Bleeding Under Direct Oral Anticoagulants

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

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

Trial sites (1)

More University Hospital, Strasbourg, France trials in France