Clinical trial NCT00282893: Balloon Prophylaxis of Aneurysmal Vasospasm
Official title: Balloon Prophylaxis of Aneurysmal Vasospasm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aneurysm
Vasospasm
Keywords: aneurysm
vasospasm
subarachnoid hemorrhage
transluminal ballooning
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2006-01-27
Enrollment: 170
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
state: California
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: University of Washington - Harborview Medical Center
state: Washington
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100
Study officials:
affiliation: Professor and Chairman, Department of Neurological Surgery, University of California, Davis
name: Jan Paul Muizelaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Interventional Neuroradiologist, University of California, Davis
name: Jonathan Hartman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Marike Zwienenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with Fisher grade III subarachnoid hemorrhage: results of a phase II multicenter, randomized, clinical trial. Stroke. 2008 Jun;39(6):1759-65. doi: 10.1161/STROKEAHA.107.502666. Epub 2008 Apr 17.