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

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.

Timeline

Start

2014-03

Primary completion

2020-02-28

Completion

2020-09-03

Outcome

Missed primary endpoint

paper In patients with recent mild-TBI receiving a VKA, systematic prompt reversal with 4f-PCC did not statistically significantly reduce ICH rate at 24 h. PMID 40315031 ↗

Publications

• Douillet D, Tazarourte K, Dehours E, Brice C, Andrianjafy H, Trinh-Duc A, Lasocki S, Labriffe M, Riou J, Roy PM. Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial. Eur J Emerg Med. 2025 Jun 1;32(3):180-187. doi: 10.1097/MEJ.0000000000001199. Epub 2024 Nov 6.

Drugs

Indications