Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06560372

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

Led by University Hospital Center of Martinique · Updated on 2025-03-31

154

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying moderate to severe traumatic brain injury (TBI) complicated by subarachnoid hemorrhage (SAH), focusing on the occurrence and evolution of cerebral vasospasm (CV) with clinical impact. CV is well described in aneurysmal SAH but less understood in traumatic cases, despite its potential impact on patient outcomes. This study aims to better define the incidence and characteristics of CV in this population at Martinique University Hospital using advanced imaging techniques. The study involves hospitalized patients with moderate or severe TBI (Glasgow Score ≤13) and traumatic SAH seen on initial brain CT scan. Patients will receive routine clinical monitoring including daily transcranial Doppler (TCD) and biological assessments. If neurological deterioration or increased intracranial pressure occurs between days 3 and 12, a cerebral CT scan with an additional brain perfusion sequence will be performed to diagnose CV. Treatment to improve cerebral perfusion and manage intracranial pressure will continue as per standard care. Participants will be closely monitored during hospitalization with clinical exams, imaging, and neurological assessments. The study will estimate the incidence of CV with clinical impact over 42 months and describe its characteristics and risk factors. Neurological outcomes will be compared at 30 days and 6 months, with quality of life also assessed. Informed consent will be obtained from patients or their representatives, and data collection will include multiple follow-up points to understand CV's effect on recovery and prognosis.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 or over
  • Hospitalized for treatment or monitoring of moderate or severe traumatic brain injury with Glasgow Score ≤13
  • Presence of subarachnoid hemorrhage on initial cerebral CT scan
  • Patient or representative has given free, informed, and written consent
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Known or diagnosed aneurysmal pathology at initial treatment
  • History of chronic kidney failure stage 4 (creatinine clearance <30 ml/min)
  • Imminent death or expected death within 48 hours
  • Patients not admitted to critical care due to poor prognosis
  • Known allergy to iodized contrast products
  • Under legal protection, guardianship, or curatorship
  • Patient or representative refuses participation
  • Minor
  • Released from hospital against medical advice
  • Transferred to another facility before day 13 of treatment
  • Withdrawal of consent during the study with refusal to use collected data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 12 days

Participants undergo neurological monitoring and additional brain perfusion scans to diagnose cerebral vasospasm.

Daily monitoring visits between Day 3 and Day 12

Long-term Monitoring

Duration - Up to 42 months

Participants are observed to estimate the incidence and characteristics of cerebral vasospasm and assess neurological outcomes up to 42 months.

Follow-up visits at 30 days and 6 months with additional assessments as needed

Trial Site Locations

Total: 1 location

1

University Hospital Center of Martinique

Fort-de-France, France, 97261

Actively Recruiting

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Research Team

M

Marie SABIA, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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