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

University Hospital, Angers

Status and phase

Terminated

Phase 3

Conditions

Haemorrhage

Craniocerebral Trauma

Coagulation; Intravascular

Treatments

Drug: Reversion

Study type

Interventional

Funder types

Other

Identifiers

NCT01961804

PHRC 2012-02

Details and patient eligibility

About

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.

Enrollment

202 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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