Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2000-10-31
2006-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Remote Ischemic Preconditioning in Subarachnoid Hemorrhage
NCT01158508
Lumbar Drain vs Extraventricular Drain to Prevent Vasospasm in Subarachnoid Hemorrhage
NCT03065231
The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
NCT07131696
Cervical Sympathetic Block in Patients With Cerebral Vasospasm
NCT05230134
Safety Study of Cervical Sympathetic Block for Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
NCT00930072
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Transluminal ballooning is a procedure that opens blood vessels, allowing blood flow and oxygen to get to the brain more easily. Researchers believe that this dilation of the blood vessels lasts for at least 7 days. This procedure is used to treat severe vasospasm although it is not commonly used to prevent vasospasm. The purpose of this trial is to find out if this procedure, performed immediately after the aneurysm is secured, prevents spasm in the brain and improves patient outcome.
Eligible SAH patients whose aneurysm has been repaired by neurosurgical or endovascular procedure and who are enrolled in the study will be randomized to receive either the prophylactic transluminal ballooning procedure or to receive standard care, which includes currently existing therapies for the treatment of vasospasm.
Participants will be asked to return for follow-up examinations at 3 and 6 months to evaluate recovery using a standardized outcome scale.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
pTBA
Prophylactic Transluminal Ballooning Angioplasty
transluminal ballooning
Control
currently existing therapies for the treatment of vasospasm
currently existing therapies for the treatment of vasospasm
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
transluminal ballooning
currently existing therapies for the treatment of vasospasm
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented ruptured cerebral aneurysm via angiography, CT angiogram or any other acceptable neuroradiologic means
* Ruptured aneurysm(s) secured
* Ballooning available \< 96 hours post SAH
Exclusion Criteria
* Interventionalist unavailable
* Patient outside the 96 hour window for ballooning
* Enrolled in competing trial
* Unsecured aneurysms (symptomatic or asymptomatic) that are in the location where the ballooning procedure would occur
* Medical conditions known that would effect mortality / morbidity
* Severe Cerebrovascular atherosclerosis
* \> 16 years old.
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, Davis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Paul Muizelaar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor and Chairman, Department of Neurological Surgery, University of California, Davis
Jonathan Hartman, MD
Role: PRINCIPAL_INVESTIGATOR
Interventional Neuroradiologist, University of California, Davis
Marike Zwienenberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
Sacramento, California, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Washington - Harborview Medical Center
Seattle, Washington, United States
University of Toronto
Toronto, Ontario, Canada
University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zwienenberg-Lee M, Hartman J, Rudisill N, Madden LK, Smith K, Eskridge J, Newell D, Verweij B, Bullock MR, Baker A, Coplin W, Mericle R, Dai J, Rocke D, Muizelaar JP; Balloon Prophylaxis for Aneurysmal Vasospasm (BPAV) Study Group. Effect of prophylactic transluminal balloon angioplasty on cerebral vasospasm and outcome in patients with Fisher grade III subarachnoid hemorrhage: results of a phase II multicenter, randomized, clinical trial. Stroke. 2008 Jun;39(6):1759-65. doi: 10.1161/STROKEAHA.107.502666. Epub 2008 Apr 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200311385
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.