Ruptured Cerebral Aneurysm, Subarachnoid Hemorrhage (SAH)
Conditions
Keywords
intracranial aneurysm, subarachnoid hemorrhage, randomized trial, coil embolization, clip occlusion, vascular disorders
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREcoil embolization
Subjects randomized to endovascular therapy will be treated by one of two neurosurgeons expert in such treatment. All endovascular treatments will be accomplished using accepted techniques.
PROCEDUREclip occlusion
Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.
Sponsors
Barrow Neurological Foundation
University of California, San Francisco
St. Joseph's Hospital and Medical Center, Phoenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 10 years | Primary Outcome Measure is Modified Rankin Scale \< or = to 2. Data will be analyzed on intent to treat basis with crossover to the alternative treatment analyzed as a data subset. The null hypothesis is that no difference in outcome will be detected between the endovascular and surgical treatment arms. A statistically significant difference will then be considered evidence in favor of the alternative hypothesis, that one treatment is superior to the other. |
Countries
United States
Outcome results
None listed