Balloon Prophylaxis of Aneurysmal Vasospasm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00282893
First received: January 26, 2006
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if early transluminal ballooning of the major cerebral arteries prevents severe vasospasm and improves neurological outcome in patients with Fisher Grade III aneurysmal subarachnoid hemorrhage.


Condition Intervention Phase
Aneurysm
Vasospasm
Procedure: transluminal ballooning
Other: currently existing therapies for the treatment of vasospasm
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Balloon Prophylaxis of Aneurysmal Vasospasm

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator

Secondary Outcome Measures:
  • Dichotomized GOS at 6 months, assessment at 3 and 6 months of: five-point GOS; GOS - Extended (GOSE), occurrence of delayed ischemic deficit (DID), the incidence of severe vasospasm as detected by Transcranial Doppler (TCD) Ultrasonography (mean blood f

Enrollment: 170
Study Start Date: October 2000
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pTBA
Prophylactic Transluminal Ballooning Angioplasty
Procedure: transluminal ballooning
Active Comparator: Control
currently existing therapies for the treatment of vasospasm
Other: currently existing therapies for the treatment of vasospasm

Detailed Description:

Aneurysmal subarachnoid hemorrhage (SAH) afflicts over 30,000 patients a year in the United States. Fifteen percent of those who survive the initial bleeding die or suffer disabilities because of delayed ischemic deficit (stroke) due to vasospasm. Vasospasm is a condition in which the arteries in the brain constrict, not allowing sufficient blood flow and oxygenation. Research on the pharmacological prevention and treatment of vasospasm has resulted in only minimal improvement for this problem.

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fisher grade III hemorrhage
  • 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:

  • Vasospasm prior to randomization
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00282893

Locations
United States, California
Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
Sacramento, California, United States, 95817
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2380
United States, Washington
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98014
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5B-1A6
Netherlands
University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Jan Paul Muizelaar, MD, PhD Professor and Chairman, Department of Neurological Surgery, University of California, Davis
Principal Investigator: Jonathan Hartman, MD Interventional Neuroradiologist, University of California, Davis
Principal Investigator: Marike Zwienenberg, MD University of California, Davis
  More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00282893     History of Changes
Other Study ID Numbers: RO1NS038484
Study First Received: January 26, 2006
Last Updated: March 12, 2014
Health Authority: United States: Federal Government

Keywords provided by University of California, Davis:
aneurysm
vasospasm
subarachnoid hemorrhage
transluminal ballooning

Additional relevant MeSH terms:
Aneurysm
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014