Actively Recruiting

Age: 18Years - 85Years
All Genders
ID07065903

Nimodipine Systemic Exposure and Outcomes Following Aneurysmal Subarachnoid Hemorrhage: A Prospective Multi-centre Observational Study (ASH-II Study)

Led by University of Alberta · Updated on 2026-02-09

500

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Nimodipine Variability in SAH

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-85 years
  • Diagnosis of aneurysmal subarachnoid hemorrhage
  • Provision of informed consent
  • Treated with nimodipine
  • Presence of intravascular catheter at the time of sampling
Not Eligible

You will not qualify if you...

  • Anticipated hospital length of stay <48 hours
  • Non-aneurysmal subarachnoid hemorrhage
  • Not treated with nimodipine
  • Incarceration
  • Delayed presentation to the hospital (>96 hours from SAH onset)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Trial Site Locations

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

Loading map...

Research Team

S

Sherif H Mahmoud, BSc (Pharm), MSc, PhD, FNCS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

Artificial Intelligence Applications for Cerebral Aneurysms ...

Unruptured Cerebral Aneurysm

Actively Recruiting

1 location

Augmented Renal Clearance in Neurocritical Care Population: ...

TBI (Traumatic Brain Injury)

Actively Recruiting

3 locations

Pterygopalatine Fossa Block as an Opioid Sparing Treatment f...

Subarachnoid Hemorrhage, Aneurysmal

Actively Recruiting

11 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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/38249736

Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

Mervyn D I Vergouwen, Marinus Vermeulen, Jan van Gijn...

https://pubmed.ncbi.nlm.nih.gov/20798370