Barrow Ruptured Aneurysm Trial

Ruptured Cerebral Aneurysm Clinical Trial

— BRAT  

Official title:

Barrow Ruptured Aneurysm Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01593267
• Other study ID #: 02BN090
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2002
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2023
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Ruptured
• Hemorrhage
• Intracranial Aneurysm
• Ruptured Cerebral Aneurysm
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage (SAH)

Intervention

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

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	Barrow Neurological Foundation, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (11)

Catapano JS, Zabramski JM, Baranoski JF, Brigeman S, Morgan CD, Hendricks BK, Mooney MA, Albuquerque FC, Nakaji P, Spetzler RF. The Prognostic Significance of a Cast Fourth Ventricle in Ruptured Aneurysm Patients With Intraventricular Hemorrhage in the Barrow Ruptured Aneurysm Trial (BRAT). Neurosurgery. 2019 Aug 1;85(2):E275-E283. doi: 10.1093/neuros/nyy493. — View Citation

Mascitelli JR, Cole T, Yoon S, Nakaji P, Albuquerque FC, McDougall CG, Zabramski JM, Lawton MT, Spetzler RF. External Validation of the Subarachnoid Hemorrhage International Trialists (SAHIT) Predictive Model Using the Barrow Ruptured Aneurysm Trial (BRAT — View Citation

Mascitelli JR, Lawton MT, Hendricks BK, Nakaji P, Zabramski JM, Spetzler RF. Analysis of Wide-Neck Aneurysms in the Barrow Ruptured Aneurysm Trial. Neurosurgery. 2019 Nov 1;85(5):622-631. doi: 10.1093/neuros/nyy439. — View Citation

McDougall CG, Spetzler RF, Albuquerque FC, Zabramski JM, Nakaji P. Crossover and clinical outcomes in the Barrow Ruptured Aneurysm Trial. Response. J Neurosurg. 2014 Feb;120(2):572. — View Citation

McDougall CG, Spetzler RF, Zabramski JM, Partovi S, Hills NK, Nakaji P, Albuquerque FC. The Barrow Ruptured Aneurysm Trial. J Neurosurg. 2012 Jan;116(1):135-44. doi: 10.3171/2011.8.JNS101767. Epub 2011 Nov 4. — View Citation

Mooney MA, Brigeman S, Bohl MA, Simon ED, Sheehy JP, Chang SW, Spetzler RF. Analysis of overlapping surgery in patients undergoing microsurgical aneurysm clipping: acute and long-term outcomes from the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2018 Sep;129(3):711-717. doi: 10.3171/2017.5.JNS17394. Epub 2017 Nov 3. — View Citation

Mooney MA, Simon ED, Brigeman S, Nakaji P, Zabramski JM, Lawton MT, Spetzler RF. Long-term results of middle cerebral artery aneurysm clipping in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2018 Apr 27;130(3):895-901. doi: 10.3171/2017.10.JNS172183. — View Citation

Spetzler RF, McDougall CG, Albuquerque FC, Zabramski JM, Hills NK, Partovi S, Nakaji P, Wallace RC. The Barrow Ruptured Aneurysm Trial: 3-year results. J Neurosurg. 2013 Jul;119(1):146-57. doi: 10.3171/2013.3.JNS12683. Epub 2013 Apr 26. Erratum in: J Neur — View Citation

Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Nakaji P, Karis JP, Wallace RC. Ten-year analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2019 Mar 8;132(3):771-776. doi: 10.3171/2018.8.JNS181846. — View Citation

Spetzler RF, McDougall CG, Zabramski JM, Albuquerque FC, Hills NK, Russin JJ, Partovi S, Nakaji P, Wallace RC. The Barrow Ruptured Aneurysm Trial: 6-year results. J Neurosurg. 2015 Sep;123(3):609-17. doi: 10.3171/2014.9.JNS141749. Epub 2015 Jun 26. — View Citation

Spetzler RF, Zabramski JM, McDougall CG, Albuquerque FC, Hills NK, Wallace RC, Nakaji P. Analysis of saccular aneurysms in the Barrow Ruptured Aneurysm Trial. J Neurosurg. 2018 Jan;128(1):120-125. doi: 10.3171/2016.9.JNS161301. Epub 2017 Feb 24. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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