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Randomized Controlled Trial
. 2025 Jun 1;32(3):180-187.
doi: 10.1097/MEJ.0000000000001199. Epub 2024 Nov 6.

Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial

Delphine Douillet  1   2   3 , Karim Tazarourte  4 , Emilie Dehours  5 , Christian Brice  6 , Hery Andrianjafy  7 , Albert Trinh-Duc  8 , Sigismond Lasocki  2   9 , Matthieu Labriffe  10 , Jérémie Riou  11   12 , Pierre-Marie Roy  1   2   3
Affiliations
Randomized Controlled Trial

Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial

Delphine Douillet et al. Eur J Emerg Med. .

Abstract

Background and importance: Traumatic brain injury (TBI) in patients on vitamin K antagonists (VKAs) is linked to a high rate of intracranial hemorrhage (ICH). Rapid reversal can reduce ICH progression and mortality, but its effectiveness depends on the time between bleeding onset and coagulation normalization.

Objective: The PREVACT study aimed to assess the efficacy and safety of prompt systematic reversal of anticoagulation in patients presenting to emergency departments (EDs) for recent mild-TBI while receiving a VKA.

Intervention: A randomized, open-label, blinded-endpoint clinical trial was conducted in 21 French EDs. Patients receiving a VKA, having experienced a TBI within the last 6 h, and presenting a Glasgow Coma Score ≥13 were included. Patients were randomized to systematic immediate VKA reversal with 25 IU/kg of four-factor prothrombin complex concentrate (4f-PCC) before any investigation (intervention group) or standard-of-care signifying reversal only if the initial cranial computed tomography (CT) scan indicated ICH (control group). The primary outcome was the rate of ICH detected on a cranial CT scan 24 h post-inclusion.

Results: The study was prematurely stopped for logistic reasons after the randomization of 202 patients (101 and 101 in the intervention and control groups, respectively, mean age 90; 51.8% female). On the 24-h cranial CT scan, 6 of 98 patients (6.1%) in the intervention group manifested ICH vs. 12 of 99 patients (12.1%) in the control group [odds ratio: 0.47 (95% confidence interval: 0.14-1.44); P = 0.215].

Conclusion: 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. However, the study was prematurely stopped and does not exclude a clinically relevant benefit of the strategy tested.

Trial registration: Clinicaltrials.gov (NCT01961804).

Keywords: anticoagulants/adverse effects; blood coagulation factors; emergency medicine; intracranial hemorrhage; reversal; traumatic brain injury; vitamin K antagonist.

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References

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