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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 : Terminated
First Posted : October 11, 2013
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE October 9, 2013
First Posted Date  ICMJE October 11, 2013
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE March 2014
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
Percentage of intracranial bleeding diagnosed in CT scan [ Time Frame: H20 +/- 4 hours ]
This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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.
  • 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
  • Percentage of patient having a systemic or neurologic ischemic attacks [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2013)
  • Volumetric measure of intracranial haemorrhage [ Time Frame: CT scan performed 20h+/-4 after inclusion ]
    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 ]
    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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coagulation; Intravascular
  • Craniocerebral Trauma
  • Haemorrhage
Intervention  ICMJE Drug: Reversion
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
Other Name: KANOKAD
Study Arms  ICMJE
  • Actual recommendations
    Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.
    Intervention: Drug: Reversion
  • Experimental: Preventive reversion
    Realise a preventive reversion before performing any CT scan.
    Intervention: Drug: Reversion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 3, 2020)
202
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 3, 2020
Actual Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01961804
Other Study ID Numbers  ICMJE PHRC 2012-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ROY Pierre-Marie, Professor UH Angers
Study Chair: TAZAROURTE Karim, Pr UH Lyon
PRS Account University Hospital, Angers
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP