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Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00282893 |
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.
Condition | Intervention | Phase |
---|---|---|
Aneurysm Vasospasm |
Procedure: transluminal ballooning |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Estimated Enrollment: | 185 |
Study Start Date: | October 2000 |
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.
Ages Eligible for Study: | 17 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada, M5B-1A6 | |
Netherlands | |
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 |
Investigator: | Jonathan Hartman, MD | Interventional Neuroradiologist, University of California, Davis (Co Investigator) |
Investigator: | Marike Zwienenberg, MD | University of California, Davis (Co Investigator) |
Study ID Numbers: | RO1NS038484 |
Study First Received: | January 26, 2006 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00282893 History of Changes |
Health Authority: | United States: Federal Government |
aneurysm vasospasm subarachnoid hemorrhage transluminal ballooning |
Aneurysm Vascular Diseases Subarachnoid Hemorrhage Hemorrhage |
Aneurysm Vascular Diseases Cardiovascular Diseases |