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Ruptured Cerebral AneurysmBRATNCT01593267

Barrow Ruptured Aneurysm Trial

A study testing coil embolization and clip occlusion in people with Ruptured Cerebral Aneurysm and Subarachnoid Hemorrhage (SAH), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
coil embolization and clip occlusion
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteUnited States
Study dates
Nov 2002to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Traumatic subarachnoid hemorrhage
  • Presents to hospital >14 days post-bleed
  • SAH caused by other primary disease
  • No anatomic exclusions

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

Other trials in United States

About this study

Official title: Barrow Ruptured Aneurysm Study

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.

Read the 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.

Being tested
coil embolization, clip occlusion
Keywords
intracranial aneurysm, subarachnoid hemorrhage, randomized trial, coil embolization, clip occlusion, vascular disorders
Medical subject headings
Subarachnoid Hemorrhage, Intracranial Aneurysm, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • coil embolizationProcedure or surgery

    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 occlusionProcedure or surgery

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

Study groups in NCT01593267
Study groupRoleWhat they receive
EndovascularActive comparatorSubjects 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.
Receives: Procedure: coil embolization
SurgicalActive comparatorSubjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.
Receives: Procedure: clip occlusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2012 (estimated)
  2. Study startNov 2002
  3. Primary completion25 Oct 2019
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01593267
Sponsor's protocol ID
02BN090
Acronym
BRAT
Status last verified
Sep 2021
First submitted
30 Apr 2012
Last updated
21 Sep 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30476225

  • 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.

    PubMed 30346618

  • 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.

    PubMed 29701554

  • 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.

    PubMed 29099301

  • 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.

    PubMed 28298031

  • 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.

    PubMed 24645176

  • 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.

    PubMed 22054213

  • 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.

    PubMed 23621600

  • 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.

    PubMed 30849758

  • 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.

    PubMed 30566611

  • 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.

    PubMed 26115467

  • 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.

    PubMed 38682903

Questions about this trial

What is this clinical trial studying?

A study testing coil embolization and clip occlusion in people with Ruptured Cerebral Aneurysm and Subarachnoid Hemorrhage (SAH), run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin Scale (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01593267, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.

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