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PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma — PREVACT  

Craniocerebral Trauma Clinical Trial

Official title:
Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment

Clinical Trial Summary

The occurence of a minor craniocerebral trauma in patients receiving vitamine K antagonist treatment leads to a high risk of bleeding. Current guidelines recommend to perform a CT scan, and, in case of intracranial bleeding, to reverse anticoagulation with concomitant administration of prothrombin complex concentrates (PCCs) and vitamin K. However, even if a reversion is performed, the prognostic of post-traumatic intracranial bleeding remain bad. The investigators hypothesize that, for patients admitted in an emergency department after a minor head trauma and receiving anticoagulant treatment, a systematic preventive reversion with PCCs can lead to a significant reduction of intracranial haemorrhage and can also improve the neurological prognostic of patients versus the current strategy. PREVACT will test this hypothesis, in an open label, randomized, multicentre, clinical trial involving 400 patients.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01961804
Study type Interventional
Source University Hospital, Angers
Contact
Status Terminated
Phase Phase 3
Start date March 2014
Completion date September 3, 2020
View Details
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