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

Primary Purpose

Coagulation; Intravascular, Craniocerebral Trauma, Haemorrhage

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Reversion
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coagulation; Intravascular

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH Agen
  • CHU Angers
  • Ch Annecy
  • CHU Chateauroux
  • CHU Clermont Ferrand
  • CHG du Mans
  • Ch Les Sables D'Olonne
  • Ch Longjumeau
  • HCL Edouard Herriot
  • CHU METZ
  • Chg Montauban
  • Chu Nantes
  • CHU Nice
  • CHU Pitié Salpétrière
  • Chu Tenon
  • Chu Poitiers
  • Chu Saint Brieuc
  • Ch Saint Malo
  • Chu Toulouse
  • Chu Tours
  • Ch Versailles

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Actual recommendations

Preventive reversion

Arm Description

Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.

Realise a preventive reversion before performing any CT scan.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Percentage of patient having a decrease in their autonomy
A loss of at least one point in the Glasgow Outcome Score Extended
Percentage of patient having a systemic or neurologic ischemic attacks

Full Information

First Posted
October 9, 2013
Last Updated
April 26, 2021
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01961804
Brief Title
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Study Start Date
March 2014 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation; Intravascular, Craniocerebral Trauma, Haemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Actual recommendations
Arm Type
Other
Arm Description
Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed.
Arm Title
Preventive reversion
Arm Type
Experimental
Arm Description
Realise a preventive reversion before performing any CT scan.
Intervention Type
Drug
Intervention Name(s)
Reversion
Other Intervention Name(s)
KANOKAD
Intervention Description
Administration of prothrombin complex concentrates: KANOKAD before CT Scan
Primary Outcome Measure Information:
Title
Percentage of intracranial bleeding diagnosed in CT scan
Description
This primary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Time Frame
24 hours +/- 4 hours
Secondary Outcome Measure Information:
Title
Volumetric measure of intracranial haemorrhage
Description
This secondary outcome measure will be analyse in a centralised place by two neuro-radiologist in blind of the randomised group.
Time Frame
CT scan performed 24 hours +/-4 after inclusion
Title
Percentage of patient having a decrease in their autonomy
Description
A loss of at least one point in the Glasgow Outcome Score Extended
Time Frame
3 months
Title
Percentage of patient having a systemic or neurologic ischemic attacks
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROY Pierre-Marie, Professor
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
TAZAROURTE Karim, Pr
Organizational Affiliation
UH Lyon
Official's Role
Study Chair
Facility Information:
Facility Name
CH Agen
City
Agen
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Ch Annecy
City
Annecy
Country
France
Facility Name
CHU Chateauroux
City
Chateauroux
Country
France
Facility Name
CHU Clermont Ferrand
City
Clermont Ferrand
Country
France
Facility Name
CHG du Mans
City
Le Mans
Country
France
Facility Name
Ch Les Sables D'Olonne
City
Les Sables d'Olonne
Country
France
Facility Name
Ch Longjumeau
City
Longjumeau
Country
France
Facility Name
HCL Edouard Herriot
City
Lyon
Country
France
Facility Name
CHU METZ
City
Metz
Country
France
Facility Name
Chg Montauban
City
Montauban
Country
France
Facility Name
Chu Nantes
City
Nantes
Country
France
Facility Name
CHU Nice
City
Nice
Country
France
Facility Name
CHU Pitié Salpétrière
City
Paris
Country
France
Facility Name
Chu Tenon
City
Paris
Country
France
Facility Name
Chu Poitiers
City
Poitiers
Country
France
Facility Name
Chu Saint Brieuc
City
Saint Brieuc
Country
France
Facility Name
Ch Saint Malo
City
Saint Malo
Country
France
Facility Name
Chu Toulouse
City
Toulouse
Country
France
Facility Name
Chu Tours
City
Tours
Country
France
Facility Name
Ch Versailles
City
Versailles
Country
France

12. IPD Sharing Statement

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

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