Phase
Condition
Hemorrhage
Brain Injury
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Admission in an emergency departement for a recent and isolated minor head trauma withat least one of the following characteristic : a period of alteration in the level ofconsciousness, a period of loss of consciousness (< 30 min), a posttraumatic amnesia,persistant posttraumatic headache, repeated vomitting (at least 2 episodes) or anyother neurological sign such a convulsion or a localised neurological sign, wound ofthe scalp or the face testifying of the importance of the cranial trauma...
- Subject receiving anticoagulant treatment with anti-vitamin K for the treatment ofatrial 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 emergencyinclusion can be realised.
Exclusion
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 (≤ 100mg/day)
- Delocalised biology INR in capillary blood < 1.5 if it's available (only indepartement where this analyse is a usual practice)
- Haemorrhage or suspected haemorrhage other than intracranial which could led to areversion 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 thesubject at increased risk of harm if he/she participated in the study
- Subject without social security registered
Study Design
Connect with a study center
CH Agen
Agen,
FranceSite Not Available
CHU Angers
Angers, 49933
FranceSite Not Available
Ch Annecy
Annecy,
FranceSite Not Available
CHU Beaumont sur Oise
Beaumont Sur Oise,
FranceSite Not Available
AVICENNE
Bobigny,
FranceSite Not Available
CHU Chateauroux
Chateauroux,
FranceSite Not Available
Ch Cholet
Cholet,
FranceSite Not Available
CHU Clermont Ferrand
Clermont Ferrand,
FranceSite Not Available
Chu Dijon
Dijon,
FranceSite Not Available
CHU Grenoble
Grenoble,
FranceSite Not Available
CHG du Mans
Le Mans,
FranceSite Not Available
Ch Les Sables D'Olonne
Les Sables d'Olonne,
FranceSite Not Available
Ch Longjumeau
Longjumeau,
FranceSite Not Available
HCL Edouard Herriot
Lyon,
FranceSite Not Available
CH MELUN
Melun,
FranceSite Not Available
CHU METZ
Metz,
FranceSite Not Available
Chg Montauban
Montauban,
FranceSite Not Available
Chu Nantes
Nantes,
FranceSite Not Available
CHU Nice
Nice,
FranceSite Not Available
CHU Pitié Salpétrière
Paris,
FranceSite Not Available
Chu Tenon
Paris,
FranceSite Not Available
Chu Poitiers
Poitiers,
FranceSite Not Available
Chu Rouen
Rouen,
FranceSite Not Available
Chu Saint Brieuc
Saint Brieuc,
FranceSite Not Available
Ch Saint Malo
Saint Malo,
FranceSite Not Available
Ch Saint-Nazaire
Saint-Nazaire,
FranceSite Not Available
Chu Toulouse
Toulouse,
FranceSite Not Available
Chu Tours
Tours,
FranceSite Not Available
Ch Versailles
Versailles,
FranceSite Not Available
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