Nimodipine systemic exposure and outcomes following aneurysmal subarachnoid hemorrhage: a pilot prospective observational study (ASH-1 study).
Sherif Hanafy Mahmoud, Fatma Hefny, Fadumo Ahmed Isse...
https://pubmed.ncbi.nlm.nih.gov/38249736Actively Recruiting
Led by University of Alberta · Updated on 2026-02-09
500
Participants Needed
3
Research Sites
N/A
Total Duration
U
University of Alberta
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
Aneurysmal subarachnoid hemorrhage (SAH) is a serious neurological condition caused by bleeding in the brain due to a ruptured aneurysm. Although it accounts for only 5% of all strokes, SAH often affects people in their middle age and can lead to significant long-term disability. Currently, nimodipine is the only medication proven to help these patients, but there may be differences in how much of the drug reaches the blood and how the two forms of nimodipine affect patients. This study is a multi-center observational research conducted in Canada and the USA, involving adult patients hospitalized for aneurysmal SAH. Researchers will collect blood samples to measure the levels of the two forms of nimodipine in each participant and observe their health outcomes over time. The study aims to understand how nimodipine levels vary and if one form has different effects, which may help develop personalized dosing in the future. Participants will be monitored for 90 days after hospital admission, with assessments including the modified Rankin Scale to evaluate functional outcomes. Blood sampling and clinical data collection will take place during hospitalization, focusing on nimodipine exposure and related complications like delayed cerebral ischemia and vasospasm. The research team will analyze these data to explore the relationship between nimodipine levels and patient recovery, contributing to better treatment strategies for SAH.
CONDITIONS
Nimodipine Variability in SAH
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days from hospital admission
Participants have blood samples collected to measure nimodipine enantiomer concentrations and clinical data collected to assess outcomes related to aneurysmal subarachnoid hemorrhage.
Visits during hospital stay and follow-up at 90 days
Total: 3 locations
1
VCU Medical Center
Richmond, Virginia, United States, 23219
Actively Recruiting
2
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Actively Recruiting
3
University Health Network - Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
S
Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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