RecruitingNCT07065903

Nimodipine Variability in SAH

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


Sponsor

University of Alberta

Enrollment

500 participants

Start Date

May 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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)

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(3)

VCU Medical Center

Richmond, Virginia, United States

University of Alberta Hospital

Edmonton, Alberta, Canada

University Health Network - Toronto Western Hospital

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07065903


Related Trials