NCT00282893

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2000

Longer than P75 for phase_2

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 15, 2017

Status Verified

March 1, 2014

Enrollment Period

5.9 years

First QC Date

January 26, 2006

Last Update Submit

February 13, 2017

Conditions

AneurysmVasospasm

Keywords

aneurysmvasospasmsubarachnoid hemorrhagetransluminal ballooning

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Study Arms (2)

pTBA

EXPERIMENTAL

Prophylactic Transluminal Ballooning Angioplasty

Procedure: transluminal ballooning

Control

ACTIVE COMPARATOR

currently existing therapies for the treatment of vasospasm

Other: currently existing therapies for the treatment of vasospasm

Interventions

transluminal ballooningPROCEDURE
pTBA
currently existing therapies for the treatment of vasospasmOTHER
Control

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery

Sacramento, California, 95817, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2380, United States

Location

University of Washington - Harborview Medical Center

Seattle, Washington, 98014, United States

Location

University of Toronto

Toronto, Ontario, M5B-1A6, Canada

Location

University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 18420953RESULT

MeSH Terms

Conditions

AneurysmSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

October 1, 2000

Primary Completion

September 1, 2006

Study Completion

December 1, 2006

Last Updated

February 15, 2017

Record last verified: 2014-03

Locations

CA(1)NL(1)US(3)