Nimodipine Variability in SAH

NCT07065903 | Recruiting

• 1 other identifier: Pro00085618
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 3

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.

Conditions

Subarachnoid Aneurysm Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal

Keywords

nimodipine; subarachnoid hemorrhage; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale (mRS) score

  The mRS is a measure of disability ranging from 0 (no symptoms) to 6 (death) and is the recommended functional outcome scale in studies involving SAH patients.

  90 days from hospital admission

Secondary Outcomes (2)

• Delayed Cerebral Ischemia (DCI)

  21 days from hospital admission

• Vasospasm

  21 days from hospital admission

Study Arms (1)

Aneurysmal subarachnoid hemorrhage (SAH) Patients

Adult patients admitted for aneurysmal SAH to any of the participating centres, who consent to participate in the study and meet the inclusion and exclusion criteria.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted for SAH to any of the participating centres.

You may qualify if:

• Age 18-85 years
• Diagnosis of aneurysmal SAH
• Provision of informed consent
• Treated with nimodipine
• Presence of intravascular catheter at the time of sampling

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Foothills Medical Centre: collaborator
• Montreal Neurological Institute and Hospital: collaborator
• University Health Network, Toronto: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (3)

VCU Medical Center

Richmond, Virginia, 23219, United States

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

RECRUITING

University Health Network - Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Related Publications (3)

• Mahmoud SH, Hefny F, Isse FA, Farooq S, Ling S, O'Kelly C, Kutsogiannis DJ. Nimodipine systemic exposure and outcomes following aneurysmal subarachnoid hemorrhage: a pilot prospective observational study (ASH-1 study). Front Neurol. 2024 Jan 5;14:1233267. doi: 10.3389/fneur.2023.1233267. eCollection 2023.

  PMID: 38249736 BACKGROUND

• Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. 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. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.

  PMID: 20798370 BACKGROUND

• Mahmoud SH, Ji X, Isse FA. Nimodipine Pharmacokinetic Variability in Various Patient Populations. Drugs R D. 2020 Dec;20(4):307-318. doi: 10.1007/s40268-020-00322-3.

  PMID: 32902829 BACKGROUND

Related Links

• Neuro-CPK Laboratory Website

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

780.492.5364; smahmoud@ualberta.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 15, 2025
• Study Start: May 13, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (1)