Barrow Ruptured Aneurysm Trial

NCT ID: NCT01593267

Last Updated: 2021-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Ruptured Cerebral Aneurysm Subarachnoid Hemorrhage (SAH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

coil embolization

Intervention Type 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.

Surgical

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

Group Type ACTIVE_COMPARATOR

clip occlusion

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

clip occlusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barrow Neurological Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role lead

Responsible Party

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Lisa Arnold

Research Operations Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert F Spetzler, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Brain and Spine

Locations

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St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30476225 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30346618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29701554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29099301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28298031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24645176 (View on PubMed)

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.

Reference Type RESULT
PMID: 22054213 (View on PubMed)

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.

Reference Type RESULT
PMID: 23621600 (View on PubMed)

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.

Reference Type RESULT
PMID: 30849758 (View on PubMed)

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.

Reference Type RESULT
PMID: 30566611 (View on PubMed)

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.

Reference Type RESULT
PMID: 26115467 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38682903 (View on PubMed)

Other Identifiers

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02BN090

Identifier Type: -

Identifier Source: org_study_id

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