Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT01961804
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01961804
Study Brief:
Protocol Section:
NCT01961804