Barrow Ruptured Aneurysm Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Barrow Ruptured Aneurysm Study

Conditions
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Ruptured Cerebral Aneurysm, Subarachnoid Hemorrhage (SAH)

Intervention / Treatment
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* Procedure: coil embolization
* Procedure: clip occlusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovascular<br>Subjects randomized to endovascular coil embolization will be treated by one of two neurosurgeons expert in such treatment. All endovascular coil embolization treatments will be accomplished using accepted techniques. | Procedure: coil embolization<br>* 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.<br>|
| Active Comparator: Surgical<br>Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms. | Procedure: clip occlusion<br>* Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | 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. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, subarachnoid hemorrhage, randomized trial, coil embolization, clip occlusion, vascular disorders