CompletedNot Applicable

Permanent Cerebral Oxymetry Monitoring for Early Diagnosis and Treatment of Delayed Vasospasm After Subarachnoid Hemorrhage

France50 participantsStarted 2019-10-01

Plain-language summary

Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction. Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection. This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women * Age ≥ 18 years * HSA of aneurysmal etiology less than 4 days before inclusion diagnosed by clinical presentation and emergency imaging * HSA "severe" defined according to the WFNS ≥ III * Intubated-ventilated patient or any other reason preventing a contributing neurological examination * Affiliate or beneficiary of a social security scheme * Free, informed and written consent signed by the representative Exclusion Criteria: * Age \<18 years * Significant vasospasm as soon as the detection was detected on the initial imaging * Possible Neurological Surveillance * Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics * Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin) * Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics * Adhesive allergy to measuring patches * Patient under guardianship or safeguard of justice * Refusal of legal representative

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Permanent measurement of cerabral oxymetry (rSO2) by NIRS system

Timeframe: From day 4 to day 12 post aneurysmal subarachnoid hemorrhage

Trial details

NCT IDNCT04042571

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-24

View on ClinicalTrials.gov More Subarachnoid Hemorrhage trials