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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
202
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
CH Agen
Agen, France
CHU Angers
Angers, France
Ch Annecy
Annecy, France
CHU Chateauroux
Châteauroux, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHG du Mans
Le Mans, France
Ch Les Sables D'Olonne
Les Sables-d'Olonne, France
Ch Longjumeau
Longjumeau, France
HCL Edouard Herriot
Lyon, France
CHU METZ
Metz, France
...and 11 more locations
Percentage of intracranial bleeding diagnosed in CT scan
This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Time frame: 24 hours +/- 4 hours
Volumetric measure of intracranial haemorrhage
This secondary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Time frame: CT scan performed 24 hours +/-4 after inclusion
Percentage of patient having a decrease in their autonomy
A loss of at least one point in the Glasgow Outcome Score Extended
Time frame: 3 months
Percentage of patient having a systemic or neurologic ischemic attacks
Time frame: 1 month
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