Balloon Prophylaxis of Aneurysmal Vasospasm

February 13, 2017 updated by: University of California, Davis
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B-1A6
        • University of Toronto
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2380
        • Vanderbilt University Medical Center
    • Washington
      • Seattle, Washington, United States, 98014
        • University of Washington - Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200311385
  • R01NS038484 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aneurysm

Clinical Trials on transluminal ballooning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe