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

NCT ID: NCT01961804

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2020-09-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Actual recommendations

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

Group Type: OTHER

Reversion

Intervention Type: DRUG

Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Preventive reversion

Realise a preventive reversion before performing any CT scan.

Group Type: EXPERIMENTAL

Reversion

Intervention Type: DRUG

Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Interventions

Reversion

Administration of prothrombin complex concentrates: KANOKAD before CT Scan

Intervention Type: DRUG

Other Intervention Names

KANOKAD

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ROY Pierre-Marie, Professor

Role: PRINCIPAL_INVESTIGATOR

UH Angers

TAZAROURTE Karim, Pr

Role: STUDY_CHAIR

UH Lyon

Locations

CH Agen

Agen, , France

CHU Angers

Angers, , France

Ch Annecy

Annecy, , France

CHU Chateauroux

Châteauroux, , France

CHU Clermont Ferrand

Clermont-Ferrand, , France

CHG du Mans

Le Mans, , France

Ch Les Sables D'Olonne

Les Sables-d'Olonne, , France

Ch Longjumeau

Longjumeau, , France

HCL Edouard Herriot

Lyon, , France

CHU METZ

Metz, , France

Chg Montauban

Montauban, , France

Chu Nantes

Nantes, , France

CHU Nice

Nice, , France

CHU Pitié Salpétrière

Paris, , France

Chu Tenon

Paris, , France

Chu Poitiers

Poitiers, , France

Chu Saint Brieuc

Saint-Brieuc, , France

Ch Saint Malo

St-Malo, , France

Chu Toulouse

Toulouse, , France

Chu Tours

Tours, , France

Ch Versailles

Versailles, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 40315031 (View on PubMed)

Other Identifiers

PHRC 2012-02

Identifier Type: -

Identifier Source: org_study_id