PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma (NCT01961804) | Clinical Trial Compass
TerminatedPhase 3
PREVACT : Preventive REversal of Vitamine K Antagonist in Minor Craniocerebral Trauma
France202 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 associate…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of intracranial bleeding diagnosed in CT scan