Balloon Prophylaxis of Aneurysmal Vasospasm
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 aneurysmal subarachnoid hemorrhage.
Procedure: transluminal ballooning
Other: currently existing therapies for the treatment of vasospasm
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Balloon Prophylaxis of Aneurysmal Vasospasm|
- Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
- Dichotomized GOS at 6 months, assessment at 3 and 6 months of: five-point GOS; GOS - Extended (GOSE), occurrence of delayed ischemic deficit (DID), the incidence of severe vasospasm as detected by Transcranial Doppler (TCD) Ultrasonography (mean blood f
|Study Start Date:||October 2000|
|Study Completion Date:||December 2006|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Prophylactic Transluminal Ballooning Angioplasty
|Procedure: transluminal ballooning|
Active Comparator: Control
currently existing therapies for the treatment of vasospasm
|Other: currently existing therapies for the treatment of vasospasm|
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 delayed ischemic deficit (stroke) due to vasospasm. Vasospasm is a condition in which the arteries in the brain constrict, not allowing sufficient blood flow and oxygenation. Research on the pharmacological prevention and treatment of vasospasm has resulted in only minimal improvement for this problem.
Transluminal ballooning is a procedure that opens blood vessels, allowing blood flow and oxygen to get to the brain more easily. Researchers believe that this dilation of the blood vessels lasts for at least 7 days. This procedure is used to treat severe vasospasm although it is not commonly used to prevent vasospasm. The purpose of this trial is to find out if this procedure, performed immediately after the aneurysm is secured, prevents spasm in the brain and improves patient outcome.
Eligible SAH patients whose aneurysm has been repaired by neurosurgical or endovascular procedure and who are enrolled in the study will be randomized to receive either the prophylactic transluminal ballooning procedure or to receive standard care, which includes currently existing therapies for the treatment of vasospasm.
Participants will be asked to return for follow-up examinations at 3 and 6 months to evaluate recovery using a standardized outcome scale.
|United States, California|
|Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery|
|Sacramento, California, United States, 95817|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-2380|
|United States, Washington|
|University of Washington - Harborview Medical Center|
|Seattle, Washington, United States, 98014|
|University of Toronto|
|Toronto, Ontario, Canada, M5B-1A6|
|University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100|
|Utrecht, Netherlands, 3584 CX|
|Principal Investigator:||Jan Paul Muizelaar, MD, PhD||Professor and Chairman, Department of Neurological Surgery, University of California, Davis|
|Principal Investigator:||Jonathan Hartman, MD||Interventional Neuroradiologist, University of California, Davis|
|Principal Investigator:||Marike Zwienenberg, MD||University of California, Davis|