Status:
COMPLETED
Balloon Prophylaxis of Aneurysmal Vasospasm
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Aneurysm
Vasospasm
Eligibility:
All Genders
17+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if early transluminal ballooning of the major cerebral arteries prevents severe vasospasm and improves neurological outcome in patients with Fisher Grade III ...
Detailed Description
Aneurysmal subarachnoid hemorrhage (SAH) afflicts over 30,000 patients a year in the United States. Fifteen percent of those who survive the initial bleeding die or suffer disabilities because of dela...
Eligibility Criteria
Inclusion
- Fisher grade III hemorrhage
- Documented ruptured cerebral aneurysm via angiography, CT angiogram or any other acceptable neuroradiologic means
- Ruptured aneurysm(s) secured
- Ballooning available \< 96 hours post SAH
Exclusion
- Vasospasm prior to randomization
- Interventionalist unavailable
- Patient outside the 96 hour window for ballooning
- Enrolled in competing trial
- Unsecured aneurysms (symptomatic or asymptomatic) that are in the location where the ballooning procedure would occur
- Medical conditions known that would effect mortality / morbidity
- Severe Cerebrovascular atherosclerosis
- \> 16 years old.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00282893
Start Date
October 1 2000
End Date
December 1 2006
Last Update
February 15 2017
Active Locations (5)
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1
Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
Sacramento, California, United States, 95817
2
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2380
3
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98014
4
University of Toronto
Toronto, Ontario, Canada, M5B-1A6