Status:
RECRUITING
Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital
Lead Sponsor:
University Hospital Center of Martinique
Conditions:
SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Context : Moderate to severe head trauma with altered state of consciousness is an extremely common pathology (between 60 and 120 cases per 100 000 people per year depending on the country and age gr...
Eligibility Criteria
Inclusion
- Adult patient aged 18 or over,
- Hospitalized at the Martinique University Hospital for the treatment or monitoring of a moderate or severe TBI (Glasgow Score less than or equal to 13 at initial treatment) presenting with SAH on the cerebral CT scan,
- Patient if capable, or representative of the patient in case of incapacity, having been informed of the research, and having given free, informed and written consent,
- After an emergency inclusion procedure if the patient's representative is initially unreachable and written agreement, informed within the first 48 hours of inclusion by the representative or the patient if his neurological condition allows it,
- Be affiliated to a social security system.
Exclusion
- Pregnant woman,
- Presence of an aneurysmal pathology known or diagnosed at initial treatment,
- History of chronic kidney failure stage 4 (creatinine clearance measured less than 30ml/min),
- Imminent death of the patient,
- Patient presenting criteria for non-admission to critical care (death expected within 48 hours, progressive fatal pathology with vital prognosis in less than 30 days, patient in palliative situation),
- Known allergy to iodized contrast products,
- Be placed under legal protection, guardianship or curatorship,
- Patient or representative who refused to allow the patient to participate in the study.
- Additional Exclusion Criteria after patient's inclusion:
- Death of the patient expected within the first 48 hours,
- Minor,
- Release from hospitalization against medical advice,
- Transfer to another establishment before the 13th day of treatment (outside the Martinique University Hospital),
- Change of opinion of the patient's representative (after neurological recovery) regarding the patient's participation in research,
- Withdrawal of consent to participate in the study being supported with refusal to use the data collected until withdrawal of participation,
Key Trial Info
Start Date :
November 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 6 2028
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06560372
Start Date
November 6 2024
End Date
December 6 2028
Last Update
March 31 2025
Active Locations (1)
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1
University Hospital Center of Martinique
Fort-de-France, France, 97261