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Clipping vs Coiling for Brain Aneurysm (BRAT Trial)
N/A
Waitlist Available
Led By Robert F Spetzler, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
BRAT Trial Summary
This trial is testing if endovascular coiling or microsurgical clipping is better for treating patients with a ruptured cerebral aneurysm.
Who is the study for?
This trial is for adults aged 18-80 who've had a recent brain bleed (subarachnoid hemorrhage) confirmed by CT or lumbar puncture. They must be able to consent to the study themselves or through a legal representative. It's not for those with traumatic SAH, arriving at the hospital more than two weeks after bleeding, or if another disease caused the SAH.Check my eligibility
What is being tested?
The trial compares two treatments for ruptured brain aneurysms: microsurgical clipping and endovascular coiling. Both are established methods but this study aims to find out which one is safer and more effective when dealing with acute subarachnoid hemorrhage.See study design
What are the potential side effects?
Possible side effects include complications from surgery such as infection, bleeding, reaction to anesthesia, stroke-like symptoms due to blood vessel manipulation, and risks associated with medical devices used during procedures.
BRAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Modified Rankin Scale
BRAT Trial Design
2Treatment groups
Active Control
Group I: SurgicalActive Control1 Intervention
Subjects randomized to surgical clip occlusion repair will receive treatment from one of two neurosurgeons expert in clip occlusion surgery for ruptured aneurysms.
Group II: EndovascularActive Control1 Intervention
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.
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Who is running the clinical trial?
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,205 Total Patients Enrolled
Barrow Neurological FoundationOTHER
7 Previous Clinical Trials
21,087 Total Patients Enrolled
University of California, San FranciscoOTHER
2,500 Previous Clinical Trials
15,235,971 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 18 and 80 years old.You have had bleeding in the space around your brain due to a head injury.No physical inclusions.You have recently had bleeding in the area around your brain, confirmed by a special kind of X-ray or a test called a lumbar puncture.You were hospitalized more than 14 days after bleeding.You have a subarachnoid hemorrhage caused by another underlying health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical
- Group 2: Endovascular
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are fresh participants currently being accepted for this research project?
"Data featured on clinicaltrials.gov suggests that this particular clinical trial, originally posted in November 2002 and last edited in September 2021, is currently not accepting participants. Despite this, there are 513 other studies actively recruiting volunteers right now."
Answered by AI
Does my profile match the criteria for participation in this clinical trial?
"For this medical study, up to 500 individuals aged 18-80 years will be considered for enrollment that have suffered a hemorrhage and no anatomical exclusions."
Answered by AI
Is the eligibility criterion for this experiment limited to participants above a certain age?
"This medical trial seeks to include individuals over 18 and under 80 years of age."
Answered by AI
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