Nimodipine Systemic Exposure and Outcomes Following Aneurysmal Subarachnoid Hemorrhage: A Prospective Multi-centre Observational Study (ASH-II Study)
University of Alberta
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.
Description
Background and Importance: Aneurysmal subarachnoid hemorrhage (SAH) is a life-threatening neurological illness characterized by the extravasation of blood into the subarachnoid space secondary to a ruptured brain aneurysm. Although SAH accounts for only 5% of all strokes, it often places a significant burden on the most productive years of a patient's life because of the relatively young average age at onset. Cerebral vasospasm and delayed cerebral ischemia (DCI) are common complications following SAH and are significant contributors to disability in those surviving the initial bleed. Several…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Criteria: * 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)
Locations (3)
- VCU Medical CenterRichmond, Virginia
- University of Alberta HospitalEdmonton, Alberta
- University Health Network - Toronto Western HospitalToronto, Ontario