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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actual recommendations | Other | Current guidelines recommend to perform a CT scan and realise the anticoagulation reversion only in case of intracranial bleeding diagnosed. |
|
| Preventive reversion | Experimental | Realise a preventive reversion before performing any CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reversion | Drug | Administration of prothrombin complex concentrates: KANOKAD before CT Scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | CT scan performed 24 hours +/-4 after inclusion |
| Percentage of patient having a decrease in their autonomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ROY Pierre-Marie, Professor | UH Angers | Principal Investigator |
| TAZAROURTE Karim, Pr | UH Lyon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Agen | Agen | France | ||||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40315031 | Derived | 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. |
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A loss of at least one point in the Glasgow Outcome Score Extended |
| 3 months |
| Percentage of patient having a systemic or neurologic ischemic attacks | 1 month |
| Angers |
| 49933 |
| 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 |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D006259 | Craniocerebral Trauma |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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