Balloon Prophylaxis of Aneurysmal Vasospasm - Full Text View

Sponsored by:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:	NCT00282893

Purpose

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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:

Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator

Secondary Outcome Measures:

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

Estimated Enrollment:	185
Study Start Date:	October 2000

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 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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282893

Locations

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

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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)

More Information

No publications provided

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

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):

aneurysm
vasospasm
subarachnoid hemorrhage
transluminal ballooning

Study placed in the following topic categories:

Aneurysm
Vascular Diseases
Subarachnoid Hemorrhage
Hemorrhage

Additional relevant MeSH terms:

Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 02, 2009