NCT01961804

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coagulation; Intravascular
• Craniocerebral Trauma
• Haemorrhage

Interventions

Type	Name	Description
DRUG	Reversion	Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Timeline

• Start date: 2014-03-01
• Primary completion: 2020-02-28
• Completion: 2020-09-03
• First posted: 2013-10-11
• Last updated: 2021-04-27

Locations

21 sites across 1 country: France