Barrow Ruptured Aneurysm Trial (BRAT)

St. Joseph's Hospital and Medical Center, Phoenix

Status: Unknown

Conditions: Ruptured Cerebral Aneurysm; Subarachnoid Hemorrhage (SAH)

Treatments: Procedure: coil embolization; Procedure: clip occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01593267

02BN090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Endovascular

Active Comparator group

Description:

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.

Treatment:

Procedure: coil embolization

Surgical

Active Comparator group

Description:

Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.

Treatment:

Procedure: clip occlusion