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Balloon Prophylaxis of Aneurysmal Vasospasm

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00282893
First received: January 26, 2006
Last updated: August 2, 2007
Last verified: August 2007
History of Changes

January 26, 2006
August 2, 2007
October 2000
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Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
Same as current
Complete list of historical versions of study NCT00282893 on ClinicalTrials.gov Archive Site
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
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
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Balloon Prophylaxis of Aneurysmal Vasospasm
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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.

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.
Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Prevention
  • Aneurysm
  • Vasospasm
Procedure: transluminal ballooning
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
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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.
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Netherlands
 
NCT00282893
RO1NS038484
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National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
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)
National Institute of Neurological Disorders and Stroke (NINDS)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP