Understanding cerebral vasospasm in traumatic brain injury with subarachnoid hemorrhage
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
NA · University Hospital Center of Martinique · NCT06560372
This study is testing how common and serious blood vessel narrowing in the brain is for adults with moderate to severe traumatic brain injuries and bleeding, to see if better scans can help improve their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Center of Martinique (other) |
| Locations | 1 site (Fort-de-France) |
| Trial ID | NCT06560372 on ClinicalTrials.gov |
What this trial studies
This study investigates the incidence and characteristics of cerebral vasospasm in patients suffering from moderate to severe traumatic brain injury complicated by subarachnoid hemorrhage. It aims to enhance the understanding of this condition, which is often overlooked in post-traumatic scenarios, by utilizing brain perfusion scans to diagnose vasospasm. The research will be conducted at the Martinique University Hospital, focusing on adult patients with specific eligibility criteria. The goal is to gather data that could improve patient outcomes through better screening and prevention strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or over with moderate to severe traumatic brain injury and subarachnoid hemorrhage, hospitalized at the Martinique University Hospital.
Not a fit: Patients with known aneurysmal pathology or those who are imminently dying may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of cerebral vasospasm in traumatic brain injury patients, potentially reducing morbidity and mortality.
How similar studies have performed: While there is established literature on aneurysmal subarachnoid hemorrhage, the approach to post-traumatic cerebral vasospasm is less explored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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,
Where this trial is running
Fort-de-France
- University Hospital Center of Martinique — Fort-de-France, France (RECRUITING)
Study contacts
- Principal investigator: Marie SABIA, PhD — University Hospital Center of Martinique
- Study coordinator: Marie SABIA, PhD
- Email: marie.sabia@chu-martinique.fr
- Phone: 05 96 55 10 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SAH, Cerebral Vasospasm, Moderate Traumatic Brain Injury, Severe Traumatic Brain Injury, Moderate and severe Traumatic Brain Injury, CT scan, Cerebral perfusion