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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Angers
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT01961804
First received: October 9, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Coagulation; Intravascular
Craniocerebral Trauma
Haemorrhage
Procedure: Reversion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • Percentage of intracranial bleeding diagnosed in CT scan [ Time Frame: H20 +/- 4 hours ] [ Designated as safety issue: Yes ]
    This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.


Secondary Outcome Measures:
  • Volumetric measure of intracranial haemorrhage [ Time Frame: CT scan performed 20h+/-4 after inclusion ] [ Designated as safety issue: Yes ]
    This secondary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.

  • Percentage of patient having a decrease in their autonomy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    A loss of at least one point in the Glasgow Outcome Score Extended

  • Percentage of patient having a systemic or neurologic ischemic attacks [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: March 2014
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Actual recommendations
Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.
Procedure: Reversion
Other Name: Administration of prothrombin complex concentrates: KANOKAD
Experimental: Preventive reversion
Realise a preventive reversion before performing any CT scan.
Procedure: Reversion
Other Name: Administration of prothrombin complex concentrates: KANOKAD

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 24h, or any other neurological sign such a convulsion or a localised neurological sign
  • 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 unable to provide written informed consent or not eligible to an emergency inclusion
  • Subject without social security registered
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961804

Contacts
Contact: ROY Pierre-Marie, Professor +33(2)-41-35-79-47 prevact@chu-angers.fr
Contact: TAZAROURTE Karim, Physiciens +33(2)-41-35-79-47 prevact@chu-angers.fr

Locations
France
CH Agen Not yet 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    pmroy@chu-angers.fr   
Contact: GABLE Béatrice    +33 2 41 35 79 47    begable@chu-angers.fr   
Principal Investigator: ROY Pierre Marie         
CHU Beaumont sur Oise Not yet recruiting
Beaumont Sur Oise, France
Principal Investigator: RICARD-HIBON Agnès, Physician         
CHU Chateauroux Not yet recruiting
Chateauroux, France
Principal Investigator: LECLERC Maence, Physician         
CHU Clermont Ferrand Not yet recruiting
Clermont Ferrand, France
Principal Investigator: SCHMIDT Jeannot, Professor         
Chu Dijon Not yet recruiting
Dijon, France
Principal Investigator: HONNARD Didier, Physician         
CHU Grenoble Not yet recruiting
Grenoble, France
Sub-Investigator: CARPENTIER Françoise, Professor         
CHG du Mans Not yet recruiting
Le Mans, France
Principal Investigator: CHOUKROUN Jacques, Physician         
CH MELUN Not yet recruiting
Melun, France
Principal Investigator: TAZAROURTE Karim, Physician         
CHU METZ Not yet recruiting
Metz, France
Principal Investigator: BRAUN François, Physician         
Chg Montauban Not yet recruiting
Montauban, France
Principal Investigator: BERTRAND Lionel, Physician         
Chu Nantes Not yet recruiting
Nantes, France
Principal Investigator: LECONTE Philippe, Professor         
Chu Avicenne Not yet recruiting
Paris, France
Principal Investigator: ADNET Frédéric, Professor         
CHU Pitié Salpétrière Not yet recruiting
Paris, France
Principal Investigator: HAUSFATER Pierre, Professor         
Chu Tenon Not yet recruiting
Paris, France
Principal Investigator: RAY Patrick, Physician         
Chu Poitiers Not yet recruiting
Poitiers, France
Principal Investigator: LARDEUR Jean Yves, Physician         
Chu Rouen Not yet recruiting
Rouen, France
Principal Investigator: JOLY Luc Marie, Professor         
Chu Saint Brieuc Recruiting
Saint Brieuc, France
Contact: HOMAOUN ALIPOUR, MD         
Principal Investigator: ALIPOUR Homauon, Physician         
Ch Saint Malo Recruiting
Saint Malo, France
Contact: VERLEY Laurent, MD         
Principal Investigator: VERLEY Laurent, Physician         
Chu Toulouse Not yet recruiting
Toulouse, France
Principal Investigator: DEHOURS Emilie, Physician         
Chu Tours Not yet recruiting
Tours, France
Principal Investigator: GABTENI Majhoub, Physician         
Sponsors and Collaborators
University Hospital, Angers
  More Information

No publications provided

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01961804     History of Changes
Other Study ID Numbers: PHRC 2012-02
Study First Received: October 9, 2013
Last Updated: May 21, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Craniocerebral Trauma
Hemorrhage
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Wounds and Injuries
Vitamin K
Vitamins
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Growth Substances
Hematologic Agents
Hemostatics
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014