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Search / Trial NCT06560372

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

Launched by UNIVERSITY HOSPITAL CENTER OF MARTINIQUE · Aug 14, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Sah (Subarachnoid Hemorrhage) Cerebral Vasospasm Moderate And Severe Traumatic Brain Injury Ct Scan Cerebral Perfusion

ClinConnect Summary

This clinical trial is studying the occurrence and effects of cerebral vasospasm (CV) in patients with moderate to severe traumatic brain injury (TBI) who also have subarachnoid hemorrhage (SAH). Cerebral vasospasm is a condition where blood vessels in the brain become narrowed, which can lead to serious complications and worsen a patient's condition. The researchers at Martinique University Hospital aim to better understand how often this happens and how it affects recovery. They will use advanced imaging techniques to assess patients and monitor their progress over time.

To be eligible for this study, participants must be adults aged 18 and older who are hospitalized at the Martinique University Hospital for moderate or severe TBI with signs of SAH. They should be able to give consent or have a representative who can consent for them if they are unable. Participants will undergo tests to monitor their brain health, and the study will help provide valuable information about the relationship between traumatic brain injury and cerebral vasospasm. This research could lead to better care and outcomes for patients with these serious conditions.

Gender

ALL

Eligibility 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,

About University Hospital Center Of Martinique

The University Hospital Center of Martinique (CHUM) is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. As a prominent academic hospital, CHUM integrates cutting-edge research with clinical practice, fostering collaborations among healthcare professionals, researchers, and academic partners. The center is committed to enhancing health outcomes in the Caribbean region by focusing on a diverse range of medical disciplines, ensuring the highest standards of ethical conduct and patient safety in all trials. Through its comprehensive approach, CHUM aims to contribute significantly to medical knowledge and the development of effective treatment options for various health conditions.

Locations

Fort De France, , France

Patients applied

0 patients applied

Trial Officials

Marie SABIA, PhD

Principal Investigator

University Hospital Center of Martinique

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported