Early Versus Late Resumption of Anticoagulation in Patients With Both High Thrombosis Risk and Major HEmoRrhage
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
In patients with a high thromboembolic risk, withdrawing anticoagulant treatment is
recommended in some situations, including when major hæmorrhage occurs. But withdrawing
treatment can be risky. In patients on a curative dose of anticoagulant medicine, treatment
withdrawal heightens the risk of thromboembolic events occurring, with potentially major
consequences. For instance, mechanical valve thrombosis is fatal in 15% of patients.
Resumption of anticoagulation is therefore critical in patients at high risk for
thromboembolic events.
However, in these patients having presented major hæmorrhage, resumption of anticoagulation
heightens the risk of hæmorrhage recurrence. This risk is even higher when the original
hæmorrhage was not accessible via surgical, endoscopic or endoluminal hemostasis.
As far as investigators know, there is no data in the literature to rely on when the major
hæmorrhage is not accessible via hemostatic intervention and the risk of thrombosis is high.
When confronted with patients who need anticoagulation but have a high risk of hæmorrhage
recurrence, the question of when treatment should be resumed has not been resolved. This is
why investigators propose to conduct a randomised comparative study to evaluate two treatment
strategies - early resumption (H48 to H72) versus late resumption (H120 to H144) of
anticoagulation.
MAIN OBJECTIVE: The main objective of the present study is to evaluate in terms of bleeding
risk, thrombosis risk and mortality at one month, the effect of early vs. late resumption of
anticoagulation in patients having presented with serious hæmorrhage while on curative-dose
anticoagulants and facing a high thromboembolic risk.