Barrow Ruptured Aneurysm Trial
This trial is active, not recruiting.
|Conditions||ruptured cerebral aneurysm, subarachnoid hemorrhage (sah)|
|Treatments||coil embolization, clip occlusion|
|Sponsor||St. Joseph's Hospital and Medical Center, Phoenix|
|Collaborator||Barrow Neurological Foundation|
|Start date||November 2002|
|End date||January 2017|
|Trial size||500 participants|
|Trial identifier||NCT01593267, 02BN090|
With evolving endovascular technologies there is a growing debate centered on the relative safety and efficacy of the currently accepted alternatives for the treatment of ruptured cerebral aneurysms in the face of acute subarachnoid hemorrhage (SAH). The purpose of this study is to compare the safety and efficacy of microsurgical clipping and endovascular coiling of acutely ruptured cerebral aneurysms in a prospective, randomized fashion.
|Intervention model||parallel assignment|
Modified Rankin Scale
time frame: 6 years
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - Acute subarachnoid hemorrhage (SAH) - Confirmed by CT scan or lumbar puncture - Age 18-80 years - Ability to give informed consent (subject or legally authorized representative) - No anatomic inclusions Exclusion Criteria: - Traumatic subarachnoid hemorrhage - Presents to hospital >14 days post-bleed - SAH caused by other primary disease - No anatomic exclusions
|Official title||Barrow Ruptured Aneurysm Study|
|Principal investigator||Robert F Spetzler, MD|
|Description||The planned trial enrolled 250 subjects per arm. Subjects are followed postoperatively and outcome endpoints will be assessed at Discharge, 6 Months, 1 Year, 3 Years, and 6 Years. One hundred (100) subjects will participate in neuropsychological testing at 1 Year; after the 100th subject an interim data analysis will be performed and the viability of future neuropsychological testing will be determined. Subjects will receive preoperative, intraoperative or postoperative, 3 Year follow up, and 6 Year follow up angiograms. In this fashion immediate clinical outcome, including peri-procedural morbidity and mortality, will be assessed as will long term outcome, both clinical and angiographic.|
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