Nimodipine Variability in SAH

Part of paid clinical trials in Richmond, Virginia.

Sponsor
University of Alberta
Study ID
NCT07065903
Status
Recruiting
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Conditions

  • Subarachnoid Aneurysm Hemorrhage
  • Subarachnoid Hemorrhage, Aneurysmal

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Feb 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

modified Rankin Scale (mRS) score [ Time Frame: 90 days from hospital admission ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VCU Medical CenterRichmondVirginia23219
Gretchen M Brophy, PharmD, BCPS, FCCP, FNCS, MCCM
[email protected]
804-828-1201

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By research site
VCU Medical Center· Richmond, VA

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