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New treatment option for SAH (Subarachnoid Hemorrhage)
Official 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
ClinicalTrials.gov ID: NCT06560372
What this study is testing
- What it's testing
- 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 group), and is responsible for 30% of deaths by trauma. It is complicated in 30-60% of cases by subarachnoid hemorrhage (SAH), which makes it the leading cause of SAH.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient if capable, or representative of the patient in case of incapacity, having been informed of the research, and having given free, informed and...
- After an emergency inclusion procedure if the patient's representative is initially unreachable and written agreement, informed within the first 48...
- Be affiliated to a social security system.
You likely can't join if
- 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...
- Known allergy to iodized contrast products,
See the full eligibility 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...
- Be affiliated to a social security system.
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Fort-de-France, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort-de-France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.