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

Craniocerebral Trauma Clinical Trial

— PREVACT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01961804
• Other study ID #: PHRC 2012-02
• Status: Terminated
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: September 3, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 202
• Est. completion date: September 3, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coagulation; Intravascular
• Craniocerebral Trauma
• Haemorrhage
• Hemorrhage

Intervention

Drug:
• Reversion
Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Locations

Country	Name	City	State
France	CH Agen	Agen
France	CHU Angers	Angers
France	Ch Annecy	Annecy
France	CHU Chateauroux	Chateauroux
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	Chg Montauban	Montauban
France	Chu Nantes	Nantes
France	CHU Nice	Nice
France	CHU Pitié Salpétrière	Paris
France	Chu Tenon	Paris
France	Chu Poitiers	Poitiers
France	Chu Saint Brieuc	Saint Brieuc
France	Ch Saint Malo	Saint Malo
France	Chu Toulouse	Toulouse
France	Chu Tours	Tours
France	Ch Versailles	Versailles

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours +/- 4 hours
Secondary	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.	CT scan performed 24 hours +/-4 after inclusion
Secondary	Percentage of patient having a decrease in their autonomy	A loss of at least one point in the Glasgow Outcome Score Extended	3 months
Secondary	Percentage of patient having a systemic or neurologic ischemic attacks		1 month