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Barrow Ruptured Aneurysm Trial (BRAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Barrow Neurological Foundation
University of California, San Francisco
Information provided by (Responsible Party):
Toby L. Anchie, R.N., MAEd, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier:
NCT01593267
First received: April 30, 2012
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Ruptured Cerebral Aneurysm
Subarachnoid Hemorrhage (SAH)
 Procedure: coil embolization
Procedure: clip occlusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Barrow Ruptured Aneurysm Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Joseph's Hospital and Medical Center, Phoenix:

Primary Outcome Measures:
  • Modified Rankin Scale [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 500
Study Start Date: November 2002
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endovascular
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
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.
Active Comparator: Surgical
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
Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593267

Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Barrow Neurological Foundation
University of California, San Francisco
Investigators
Principal Investigator: Robert F Spetzler, MD Barrow Neurosurgical Associates
Principal Investigator: Cameron G McDougall, MD Barrow Neurosurgical Associates
  More Information

Publications:

Responsible Party: Toby L. Anchie, R.N., MAEd, Executive Director, Research & Development, St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT01593267     History of Changes
Other Study ID Numbers: 02BN090
Study First Received: April 30, 2012
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Joseph's Hospital and Medical Center, Phoenix:
intracranial aneurysm
subarachnoid hemorrhage
randomized trial
 coil embolization
clip occlusion
vascular disorders

Additional relevant MeSH terms:
Aneurysm
Aneurysm, Ruptured
Intracranial Aneurysm
Brain Diseases
Hemorrhage
Subarachnoid Hemorrhage
Rupture
Vascular Diseases
 Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Intracranial Arterial Diseases

ClinicalTrials.gov processed this record on May 23, 2013