Balloon Prophylaxis of Aneurysmal Vasospasm

Phase 2

Completed

• Conditions: Aneurysm; Vasospasm
• Interventions: Other: currently existing therapies for the treatment of vasospasm; Procedure: transluminal ballooning

• Registration Number: NCT00282893
• Lead Sponsor: University of California, Davis

Brief Summary

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.

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.

Study Timeline

• Study Start: 2000-10
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2014-03
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	currently existing therapies for the treatment of vasospasm	currently existing therapies for the treatment of vasospasm
pTBA	transluminal ballooning	Prophylactic Transluminal Ballooning Angioplasty

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery; 🇺🇸 Sacramento, California, United States

University of Washington - Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100; 🇳🇱 Utrecht, Netherlands