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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01961804
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
University Hospital, Angers

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.

Condition or disease Intervention/treatment Phase
Coagulation; Intravascular Craniocerebral Trauma Haemorrhage Drug: Reversion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Actual recommendations
Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.
Drug: Reversion
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
Other Name: KANOKAD

Experimental: Preventive reversion
Realise a preventive reversion before performing any CT scan.
Drug: Reversion
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
Other Name: KANOKAD

Primary Outcome Measures :
  1. Percentage of intracranial bleeding diagnosed in CT scan [ Time Frame: 24 hours +/- 4 hours ]
    This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.

Secondary Outcome Measures :
  1. Volumetric measure of intracranial haemorrhage [ Time Frame: CT scan performed 24 hours +/-4 after inclusion ]
    This secondary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.

  2. Percentage of patient having a decrease in their autonomy [ Time Frame: 3 months ]
    A loss of at least one point in the Glasgow Outcome Score Extended

  3. Percentage of patient having a systemic or neurologic ischemic attacks [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01961804

Contact: ROY Pierre-Marie, Professor +33(2)-41-35-79-47
Contact: TAZAROURTE Karim, Professor +33(2)-41-35-79-47

CH Agen Recruiting
Agen, France
Principal Investigator: TRINH DUC Albert, Physician         
CHU Angers Recruiting
Angers, France, 49933
Contact: ROY Pierre Marie, PhD    +33 2 41 35 37 15   
Contact: GABLE Béatrice    +33 2 41 35 79 47   
Principal Investigator: ROY Pierre Marie         
Ch Annecy Recruiting
Annecy, France
Contact: Dominique SAVARY, Dr   
CHU Beaumont sur Oise Withdrawn
Beaumont Sur Oise, France
AVICENNE Withdrawn
Bobigny, France
CHU Chateauroux Terminated
Chateauroux, France
Ch Cholet Withdrawn
Cholet, France
CHU Clermont Ferrand Terminated
Clermont Ferrand, France
Chu Dijon Withdrawn
Dijon, France
CHG du Mans Terminated
Le Mans, France
Ch Les Sables D'Olonne Active, not recruiting
Les Sables d'Olonne, France
Ch Longjumeau Recruiting
Longjumeau, France
Principal Investigator: Hery ANDRIANJAFY         
HCL Edouard Herriot Recruiting
Lyon, France
Contact: Laurent JACQUIN, PhD   
CHU METZ Recruiting
Metz, France
Principal Investigator: HOFFMANN Mathieu, Physician         
Chg Montauban Terminated
Montauban, France
Chu Nantes Terminated
Nantes, France
CHU Nice Recruiting
Nice, France
Contact: Jacques LEVRAUT, PhD   
CHU Pitié Salpétrière Terminated
Paris, France
Chu Tenon Terminated
Paris, France
Chu Poitiers Recruiting
Poitiers, France
Principal Investigator: LARDEUR Jean Yves, Physician         
Chu Rouen Withdrawn
Rouen, France
Chu Saint Brieuc Recruiting
Saint Brieuc, France
Contact: BRICE Christian, MD         
Principal Investigator: BRICE Christian, Physician         
Ch Saint Malo Recruiting
Saint Malo, France
Contact: VERLEY Laurent, MD         
Principal Investigator: VERLEY Laurent, Physician         
Ch Saint-Nazaire Withdrawn
Saint-Nazaire, France
Chu Toulouse Recruiting
Toulouse, France
Principal Investigator: DEHOURS Emilie, Physician         
Chu Tours Terminated
Tours, France
Ch Versailles Active, not recruiting
Versailles, France
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: ROY Pierre-Marie, Professor UH Angers
Study Chair: TAZAROURTE Karim, Pr UH Lyon

Responsible Party: University Hospital, Angers Identifier: NCT01961804     History of Changes
Other Study ID Numbers: PHRC 2012-02
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Craniocerebral Trauma
Pathologic Processes
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Vitamin K
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action