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Completed

NCT Number: NCT00282893

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.

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Key information

Conditions

Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Toronto, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

transluminal ballooning

Procedure

currently existing therapies for the treatment of vasospasm

Other

Primary outcomes

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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2000
Primary completion
2006
Study completion
2006
First posted
Jan 27, 2006
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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