| NCT ID | NCT07065903 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Subarachnoid Aneurysm Hemorrhage |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-05-13 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-05-13 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aneurysmal subarachnoid hemorrhage (SAH) is a life-threatening neurological illness: it is bleeding in the brain after a bulging blood vessel (a brain aneurysm) ruptures. Although SAH accounts for only 5% of all strokes, it often happens in middle age and it puts a significant burden on many patients during their most productive years. Complications following SAH are common, and they can cause major long-term disability. Only one medication - nimodipine - has been proven to benefit the health and wellbeing of these patients. All SAH patients should receive nimodipine for 21 days at a fixed dose. However, our early work suggested that all patients are not getting equal amounts of nimodipine into their blood. In addition, the two different forms (structural mirror images) of nimodipine might have different effects. Reduced amounts of nimodipine in the blood may lessen its benefit and contribute to worsening health and wellbeing of SAH patients. The overall goal of this research is to see what happens with different nimodipine doses and to confirm whether the two forms of nimodipine have different effects. The investigators will conduct a multi-centre study in adult patients admitted for SAH in Canada and the USA. The investigators will collect blood samples to determine the amount of each type of nimodipine in each participant's body, and then will check to see how each participant is doing at 90 days following SAH. They will also check other factors affecting nimodipine levels, so that they can in the future suggest dose recommendations that are actually tailored to each patient.
Eligibility Criteria
Inclusion Criteria: * Age 18-85 years * Diagnosis of aneurysmal SAH * Provision of informed consent * Treated with nimodipine * Presence of intravascular catheter at the time of sampling Exclusion Criteria: * Anticipated hospital length of stay \<48 hours * Non-aneurysmal SAH * Not treated with nimodipine * Incarceration * Delayed presentation to the hospital (\>96 h from SAH onset)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07065903 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Subarachnoid Aneurysm Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07065903 currently recruiting?
Yes, NCT07065903 is actively recruiting participants. Contact the research team at smahmoud@ualberta.ca for enrollment information.
Where is the NCT07065903 trial being conducted?
This trial is being conducted at Richmond, United States, Edmonton, Canada, Toronto, Canada.
Who is sponsoring the NCT07065903 clinical trial?
NCT07065903 is sponsored by University of Alberta. The trial plans to enroll 500 participants.