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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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