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

NCT01961804 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2021-04-27

No results posted yet for this study

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

DRUG

Reversion

Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • ROY Pierre-Marie, Professor · UH Angers

  • TAZAROURTE Karim, Pr · UH Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2020-02-28
Completion
2020-09-03

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01961804 on ClinicalTrials.gov