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

Last updated: April 26, 2021
Sponsor: University Hospital, Angers
Overall Status: Terminated

Phase

3

Condition

Hemorrhage

Brain Injury

Treatment

N/A

Clinical Study ID

NCT01961804
PHRC 2012-02
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Admission in an emergency departement for a recent and isolated minor head trauma withat least one of the following characteristic : a period of alteration in the level ofconsciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia,persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or anyother neurological sign such a convulsion or a localised neurological sign, wound ofthe scalp or the face testifying of the importance of the cranial trauma...
  • Subject receiving anticoagulant treatment with anti-vitamin K for the treatment ofatrial fibrillation (AF)
  • Initial ED Glasgow Coma Scale (GCS) score of ≥13
  • Achievable follow up
  • Informed consent form signed by the patient or if he/she isn't able an emergencyinclusion can be realised.

Exclusion

Exclusion Criteria:

  • Delay between the minor head trauma and the possible preventive PCC's administration > 6h
  • Subject receiving anticoagulant treatment other than anti vitamin K (heparin,fondaparinux, dabigatran, rivaroxaban, apixaban...)
  • Subject receiving anticoagulant treatment for other reason than a AF
  • Subject on antiplatelet treatment (except the use of low dose of aspirin (≤ 100mg/day)
  • Delocalised biology INR in capillary blood < 1.5 if it's available (only indepartement where this analyse is a usual practice)
  • Haemorrhage or suspected haemorrhage other than intracranial which could led to areversion of the anticoagulation
  • Head trauma associated with one or further potential haemorrhagic traumatic lesions
  • Subject who reject the use of products derived from human blood
  • Women who are pregnant
  • Subject with any condition that, as judged by the investigator, would place thesubject at increased risk of harm if he/she participated in the study
  • Subject without social security registered

Study Design

Total Participants: 202
Study Start date:
March 01, 2014
Estimated Completion Date:
September 03, 2020

Connect with a study center

  • CH Agen

    Agen,
    France

    Site Not Available

  • CHU Angers

    Angers, 49933
    France

    Site Not Available

  • Ch Annecy

    Annecy,
    France

    Site Not Available

  • CHU Beaumont sur Oise

    Beaumont Sur Oise,
    France

    Site Not Available

  • AVICENNE

    Bobigny,
    France

    Site Not Available

  • CHU Chateauroux

    Chateauroux,
    France

    Site Not Available

  • Ch Cholet

    Cholet,
    France

    Site Not Available

  • CHU Clermont Ferrand

    Clermont Ferrand,
    France

    Site Not Available

  • Chu Dijon

    Dijon,
    France

    Site Not Available

  • CHU Grenoble

    Grenoble,
    France

    Site Not Available

  • CHG du Mans

    Le Mans,
    France

    Site Not Available

  • Ch Les Sables D'Olonne

    Les Sables d'Olonne,
    France

    Site Not Available

  • Ch Longjumeau

    Longjumeau,
    France

    Site Not Available

  • HCL Edouard Herriot

    Lyon,
    France

    Site Not Available

  • CH MELUN

    Melun,
    France

    Site Not Available

  • CHU METZ

    Metz,
    France

    Site Not Available

  • Chg Montauban

    Montauban,
    France

    Site Not Available

  • Chu Nantes

    Nantes,
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CHU Pitié Salpétrière

    Paris,
    France

    Site Not Available

  • Chu Tenon

    Paris,
    France

    Site Not Available

  • Chu Poitiers

    Poitiers,
    France

    Site Not Available

  • Chu Rouen

    Rouen,
    France

    Site Not Available

  • Chu Saint Brieuc

    Saint Brieuc,
    France

    Site Not Available

  • Ch Saint Malo

    Saint Malo,
    France

    Site Not Available

  • Ch Saint-Nazaire

    Saint-Nazaire,
    France

    Site Not Available

  • Chu Toulouse

    Toulouse,
    France

    Site Not Available

  • Chu Tours

    Tours,
    France

    Site Not Available

  • Ch Versailles

    Versailles,
    France

    Site Not Available

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