Historical collection · First published Nov 6, 2024; added to EM Weekly Oct 28, 2026. This retrospective summary may be superseded by later evidence or guidance.
← All articlesSystematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial
Summary
PREVACT randomized 202 vitamin K antagonist-treated patients with mild traumatic brain injury (GCS at least 13 within 6 hours) across 21 French EDs to immediate 25 IU/kg four-factor prothrombin complex concentrate before imaging versus reversal only if the initial cranial CT showed intracranial hemorrhage. At 24 hours, ICH was present in 6/98 patients (6.1%) with immediate reversal versus 12/99 (12.1%) with CT-triggered reversal (OR 0.47, 95% CI 0.14-1.44; P=.215). The trial stopped early for logistical reasons, so it did not establish benefit and cannot exclude a clinically important effect.
Why it matters
This small, underpowered trial does not support treating routine pre-CT PCC reversal for every VKA-treated mild-TBI patient as proven superior to CT-triggered reversal. The wide confidence interval leaves substantial uncertainty, so current reversal guidance and local protocols remain important.
Study at a glance
- Design
- Randomized trial
- Population
- Adults receiving a vitamin K antagonist who presented to one of 21 French emergency departments within 6 hours of traumatic brain injury with Glasgow Coma Scale at least 13.
- Sample size
- 202
- Intervention
- Immediate systematic vitamin K antagonist reversal with 25 IU/kg four-factor prothrombin complex concentrate before any diagnostic investigation.
- Comparator
- Standard care with anticoagulation reversal only if the initial cranial CT demonstrated intracranial hemorrhage.
- Primary endpoint
- Intracranial hemorrhage detected on cranial CT 24 hours after inclusion.
Main findings
- Twenty-four-hour ICH occurred in 6/98 evaluable intervention patients (6.1%) versus 12/99 control patients (12.1%); OR 0.47 (95% CI 0.14-1.44), P=.215.
- The study was prematurely stopped for logistical reasons after 202 patients were randomized, leaving it underpowered for a clinically important treatment effect.
- The reviewed abstract did not provide detailed numerical adverse-event results.
Limitations
The trial stopped early after 202 randomized patients, had a mean participant age of 90 years, and was open-label with blinded endpoint assessment; the effect estimate was imprecise. Only the primary abstract was reviewed, and it did not provide detailed adverse-event estimates, so safety differences could not be independently quantified.
Read the primary source
Full text: Abstract available; full text paywalled.
Original sourceDOI: 10.1097/MEJ.0000000000001199
PMID: 40315031
Material reviewed: abstract.
Source retrieved Oct 28, 2026. Historical backfill. The current PubMed primary abstract record was reviewed and lists Epub 2024-11-06, DOI 10.1097/MEJ.0000000000001199, and PMID 40315031. A targeted DOI/title search did not identify a correction or retraction. No paywall was bypassed; detailed adverse-event estimates were not available in the reviewed abstract.
Corrections & review history
No corrections recorded. Human review: not yet human-reviewed.