Barrow Ruptured Aneurysm Trial

Not Applicable

• Conditions: Subarachnoid Hemorrhage (SAH); Ruptured Cerebral Aneurysm
• Interventions: Procedure: coil embolization; Procedure: clip occlusion

• Registration Number: NCT01593267
• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix

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.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2012-04-30
• Study First Submitted QC: 2012-05-04
• Study First Posted: 2012-05-08
• Primary Completion: 2019-10-25
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular	coil embolization	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.
Surgical	clip occlusion	Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States