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

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ClinicalTrials.gov Identifier: NCT01961804
Recruitment Status : Unknown
Verified April 2018 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : October 11, 2013
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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, 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01961804


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

Locations
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Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: ROY Pierre-Marie, Professor UH Angers
Study Chair: TAZAROURTE Karim, Pr UH Lyon
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT01961804    
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:
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Craniocerebral Trauma
Hemorrhage
Pathologic Processes
 Wounds and Injuries
Trauma, Nervous System
Nervous System Diseases