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
This trial does not accept healthy volunteersQualifiers
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 population
Adult patients admitted for SAH to any of the participating centres.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Delayed Cerebral Ischemia (DCI)
DCI is defined as "the occurrence of focal neurological impairment or a decrease of at least 2 points on the GCS. Such changes are not apparent immediately after aneurysm occlusion and cannot be attributed to other causes"
Vasospasm
Vasospasm is defined as the presence of angiographic evidence of cerebral arterial narrowing
Sponsors and contacts
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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