Nimodipine Variability in SAH

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Alberta

About this trial

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 criteria

Qualifiers

Age 18-85 years

Diagnosis of aneurysmal SAH

Provision of informed consent

Treated with nimodipine

Disqualifiers

Anticipated hospital length of stay <48 hours

Non-aneurysmal SAH

Not treated with nimodipine

Incarceration

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

500 Participants
are grouped into 1 trial group

Sponsors and collaborators

University of Alberta

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Alberta Health services

Collaborator

Foothills Medical Centre

Collaborator

Montreal Neurological Institute and Hospital

Collaborator

University Health Network, Toronto

Collaborator

Virginia Commonwealth University

Collaborator