Clinical trial NCT01961804: PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
Official title: Phase 3 Study Comparing Preventive Reversal of Vitamine K Antagonist Versus Reversion Only in Case of Intracranial Bleeding in Patients Receiving Vitamine K Antagonist Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coagulation; Intravascular
Craniocerebral Trauma
Haemorrhage
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-10-11
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* Admission in an emergency departement for a recent and isolated minor head trauma with at least one of the following characteristic : a period of alteration in the level of consciousness, a period of loss of consciousness (\< 30 min), a posttraumatic amnesia, persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or any other neurological sign such a convulsion or a localised neurological sign, wound of the scalp or the face testifying of the importance of the cranial trauma...
* Subject receiving anticoagulant treatment with anti-vitamin K for the treatment of atrial 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 emergency inclusion can be realised.

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 (≤ 100 mg/day)
* Delocalised biology INR in capillary blood \< 1.5 if it's available (only in departement where this analyse is a usual practice)
* Haemorrhage or suspected haemorrhage other than intracranial which could led to a reversion 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 the subject at increased risk of harm if he/she participated in the study
* Subject without social security registered

Primary outcomes:
measure: Percentage of intracranial bleeding diagnosed in CT scan
timeFrame: 24 hours +/- 4 hours
Secondary outcomes:
measure: Volumetric measure of intracranial haemorrhage
timeFrame: CT scan performed 24 hours +/-4 after inclusion
measure: Percentage of patient having a decrease in their autonomy
timeFrame: 3 months
measure: Percentage of patient having a systemic or neurologic ischemic attacks
timeFrame: 1 month
Other outcomes:
Locations:
city: Agen
country: France
facility: CH Agen
city: Angers
country: France
facility: CHU Angers
city: Annecy
country: France
facility: Ch Annecy
city: Chateauroux
country: France
facility: CHU Chateauroux
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Le Mans
country: France
facility: CHG du Mans
city: Les Sables d'Olonne
country: France
facility: Ch Les Sables D'Olonne
city: Longjumeau
country: France
facility: Ch Longjumeau
city: Lyon
country: France
facility: HCL Edouard Herriot
city: Metz
country: France
facility: CHU METZ
city: Montauban
country: France
facility: Chg Montauban
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: CHU Pitié Salpétrière
city: Paris
country: France
facility: Chu Tenon
city: Poitiers
country: France
facility: Chu Poitiers
city: Saint Brieuc
country: France
facility: Chu Saint Brieuc
city: Saint Malo
country: France
facility: Ch Saint Malo
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: Chu Tours
city: Versailles
country: France
facility: Ch Versailles
Study officials:
affiliation: UH Angers
name: ROY Pierre-Marie, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: UH Lyon
name: TAZAROURTE Karim, Pr
role: STUDY_CHAIR
References: