Barrow Ruptured Aneurysm Trial

NCT01593267 | Unknown

• 1 other identifier: 02BN090
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Cerebral Aneurysm; Subarachnoid Hemorrhage (SAH)

Keywords

intracranial aneurysm; subarachnoid hemorrhage; randomized trial; coil embolization; clip occlusion; vascular disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Endovascular

ACTIVE COMPARATOR

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

Surgical

ACTIVE COMPARATOR

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

Interventions

coil embolization PROCEDURE

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.

Endovascular

clip occlusion PROCEDURE

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

Surgical

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Traumatic subarachnoid hemorrhage
• Presents to hospital \>14 days post-bleed
• SAH caused by other primary disease

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Barrow Neurological Foundation: collaborator
• University of California, San Francisco: collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (12)

• 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.

  PMID: 30476225 BACKGROUND

• 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.

  PMID: 30346618 BACKGROUND

• 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. 2019 Mar 1;130(3):895-901. doi: 10.3171/2017.10.JNS172183. Epub 2018 Apr 27.

  PMID: 29701554 BACKGROUND

• 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.

  PMID: 29099301 BACKGROUND

• 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.

  PMID: 28298031 BACKGROUND

• 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. No abstract available.

  PMID: 24645176 BACKGROUND

• 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.

  PMID: 22054213 RESULT

• 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.

  PMID: 23621600 RESULT

• 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. Print 2020 Mar 1.

  PMID: 30849758 RESULT

• 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) Cohort. Neurosurgery. 2020 Jan 1;86(1):101-106. doi: 10.1093/neuros/nyy600.

  PMID: 30566611 RESULT

• 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.

  PMID: 26115467 RESULT

• Labib MA, Catapano JS, Inoue M, Kupanoff KM, Singh R, Abramov I, Scherschinski L, Srinivasan VM, Youn TS, Spetzler RF, Lawton MT. External Validation of the Modified Southwestern Aneurysm Severity Index in the Barrow Ruptured Aneurysm Trial Surgical Cohort. Neurosurgery. 2024 Sep 1;95(3):660-668. doi: 10.1227/neu.0000000000002959. Epub 2024 Apr 29.

  PMID: 38682903 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Intracranial Aneurysm; Vascular Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Arterial Diseases; Aneurysm

Study Officials

• Robert F Spetzler, MD

  Barrow Brain and Spine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Operations Manager

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 8, 2012
• Study Start: November 1, 2002
• Primary Completion: October 25, 2019
• Study Completion: December 31, 2023
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)