Balloon Prophylaxis of Aneurysmal Vasospasm

Aneurysm Clinical Trial

Official title:

Balloon Prophylaxis of Aneurysmal Vasospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282893
• Other study ID #: 200311385
• Secondary ID: R01NS038484
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2006
• Last updated: February 13, 2017
• Start date: October 2000
• Est. completion date: December 2006

Study information

• Verified date: March 2014
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Vasospasm

Intervention

Procedure:
• transluminal ballooning

Other:
• currently existing therapies for the treatment of vasospasm

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
Netherlands	University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100	Utrecht
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery	Sacramento	California
United States	University of Washington - Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada,  Netherlands, 

References & Publications (1)

Zwienenberg-Lee M, Hartman J, Rudisill N, Madden LK, Smith K, Eskridge J, Newell D, Verweij B, Bullock MR, Baker A, Coplin W, Mericle R, Dai J, Rocke D, Muizelaar JP; Balloon Prophylaxis for Aneurysmal Vasospasm (BPAV) Study Group.. Effect of prophylactic — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
Secondary	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