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

NCT01961804 | Terminated Phase 3

• 1 other identifier: PHRC 2012-02
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 21

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.

Conditions

Coagulation; Intravascular; Craniocerebral Trauma; Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours +/- 4 hours

Secondary Outcomes (3)

• Volumetric measure of intracranial haemorrhage

  CT scan performed 24 hours +/-4 after inclusion

• Percentage of patient having a decrease in their autonomy

  3 months

• Percentage of patient having a systemic or neurologic ischemic attacks

  1 month

Study Arms (2)

Actual recommendations

OTHER

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

Drug: Reversion

Preventive reversion

EXPERIMENTAL

Realise a preventive reversion before performing any CT scan.

Drug: Reversion

Interventions

Reversion DRUG

Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Also known as: KANOKAD

Actual recommendations; Preventive reversion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (21)

CH Agen

Agen, France

Location

CHU Angers

Angers, 49933, France

Location

Ch Annecy

Annecy, France

Location

CHU Chateauroux

Châteauroux, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CHG du Mans

Le Mans, France

Location

Ch Les Sables D'Olonne

Les Sables-d'Olonne, France

Location

Ch Longjumeau

Longjumeau, France

Location

HCL Edouard Herriot

Lyon, France

Location

CHU METZ

Metz, France

Location

Chg Montauban

Montauban, France

Location

Chu Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU Pitié Salpétrière

Paris, France

Location

Chu Tenon

Paris, France

Location

Chu Poitiers

Poitiers, France

Location

Chu Saint Brieuc

Saint-Brieuc, France

Location

Ch Saint Malo

St-Malo, France

Location

Chu Toulouse

Toulouse, France

Location

Chu Tours

Tours, France

Location

Ch Versailles

Versailles, France

Location

Related Publications (1)

• Douillet D, Tazarourte K, Dehours E, Brice C, Andrianjafy H, Trinh-Duc A, Lasocki S, Labriffe M, Riou J, Roy PM. Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial. Eur J Emerg Med. 2025 Jun 1;32(3):180-187. doi: 10.1097/MEJ.0000000000001199. Epub 2024 Nov 6.

  PMID: 40315031 DERIVED

MeSH Terms

Conditions

Thrombosis; Craniocerebral Trauma; Hemorrhage

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• ROY Pierre-Marie, Professor

  UH Angers

  PRINCIPAL INVESTIGATOR

• TAZAROURTE Karim, Pr

  UH Lyon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: March 1, 2014
• Primary Completion: February 28, 2020
• Study Completion: September 3, 2020
• Last Updated: April 27, 2021

Record last verified: 2020-08

Locations

FR (21)