Nimodipine blood levels and enantiomer differences in aneurysmal subarachnoid hemorrhage.
Nimodipine Systemic Exposure and Outcomes Following Aneurysmal Subarachnoid Hemorrhage: A Prospective Multi-centre Observational Study (ASH-II Study)
University of Alberta · NCT07065903
This project will test whether different amounts and the two forms of nimodipine get into the blood of adults with aneurysmal subarachnoid hemorrhage and whether that relates to their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alberta (other) |
| Locations | 3 sites (Richmond, Virginia and 2 other locations) |
| Trial ID | NCT07065903 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational study measuring plasma concentrations of racemic nimodipine and its two enantiomers in adults treated for aneurysmal subarachnoid hemorrhage. Participants who receive standard nimodipine and have intravascular access will provide timed blood samples while clinical data on complications and outcomes are collected. The team will analyze predictors of low systemic exposure and whether lower or different enantiomer exposures are linked with delayed cerebral ischemia or worse functional outcomes. Results will inform whether exposure variability or enantiomer differences may explain variation in patient response to standard nimodipine dosing.
Who should consider this trial
Good fit: Adults aged 18–85 with aneurysmal subarachnoid hemorrhage who are being treated with nimodipine, can provide consent, and have intravascular access for sampling are ideal candidates.
Not a fit: People with non-aneurysmal SAH, those not treated with nimodipine, incarcerated individuals, or patients who present more than 96 hours after bleed or are discharged within 48 hours are not likely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could enable more personalized nimodipine dosing or formulation choices to improve recovery and reduce disability after aneurysmal SAH.
How similar studies have performed: Prior pilot data from the investigators showed substantial variability in nimodipine plasma levels and suggested possible enantiomer differences, but enantiomer-specific clinical effects remain largely unproven.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Richmond, Virginia and 2 other locations
- VCU Medical Center — Richmond, Virginia, United States (RECRUITING)
- University of Alberta Hospital — Edmonton, Alberta, Canada (RECRUITING)
- University Health Network - Toronto Western Hospital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS
- Email: smahmoud@ualberta.ca
- Phone: 780.492.5364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Subarachnoid Aneurysm Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, nimodipine, subarachnoid hemorrhage, pharmacokinetics