Nimodipine blood levels and enantiomer differences in aneurysmal subarachnoid hemorrhage.
Official title: Nimodipine Systemic Exposure and Outcomes Following Aneurysmal Subarachnoid Hemorrhage: A Prospective Multi-centre Observational Study (ASH-II Study)
Run by University of Alberta · NCT07065903 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Locations | 3 sites (Richmond, Virginia and 2 other locations) |
| Status | Recruiting |
| Started | May 13, 2024 |
| Main results expected | September 2029 |
| Study ends | September 2029 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07065903 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.