The primary objective of the study is to determine the optimal intra-arterial drug treatment regimen for arterial lumen restoration after cerebral vasospasm following aneurysmal subarachnoid hemorrhage. The secondary objective is to evaluate clinical outcome 90 days after patient discharge following in-hospital optimal intra-arterial drug treatment for cerebral vasospasm. This study is a prospective multicenter randomized trial.
Inclusion Criteria
- Adult patients with ruptured aneurysms requiring surgery or endovascular therapy and who experience vasospasm post-operatively (3-21 days post-procedure)
- Symptomatic vasospasm (clinical or TCD)
- For centers that perform a routine day 7 angiogram post-aneurysm treatment – 50% or more stenosis seen on diagnostic angiogram for asymptomatic patients.
Exclusion Criteria
- Pregnant women (confirmed by a positive pregnancy test)
- Hunt Hess (HH) grade 5
- Intra-arterial drug treatment in all 3 arterial territories
Study Requirements
The total duration for study participation required is the standard hospital stay for postaSAH vasospasm treatment and one follow-up clinic visit at 3 months following hospital discharge. For this clinical trial no additional clinical or laboratory evaluations are required apart from the standard hospital routine care procedures. The total study time frame is 24 months (18 months for enrollment + 3 months follow up and ± 3 months to accommodate any scheduling conflict and data gathering).
