AneurysmPhase 2NCT00282893
Balloon Prophylaxis of Aneurysmal Vasospasm
A Phase 2 study testing transluminal ballooning and currently existing therapies for the treatment of vasospasm in people with Aneurysm and Vasospasm, run by University of California, Davis at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- What is being tested?
- transluminal ballooning and currently existing therapies for the treatment of vasospasm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2000to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2380
Coordinating Center: University of California, Davis Medical Center, Department of Neurological Surgery
Sacramento, California, 95817
University of Washington - Harborview Medical Center
Seattle, Washington, 98014
Netherlands1 site
University Medical Center Utrecht, Trialbeureau Neurodivisie, Heidelberglaan 100
Utrecht, 3584 CX
About this study
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.
Read the 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.
- Being tested
- transluminal ballooning, currently existing therapies for the treatment of vasospasm
- Keywords
- aneurysm, vasospasm, subarachnoid hemorrhage, transluminal ballooning
- Medical subject headings
- Aneurysm, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transluminal ballooningProcedure or surgery
currently existing therapies for the treatment of vasospasmOther
| Study group | Role | What they receive |
|---|---|---|
| pTBA | Experimental | Prophylactic Transluminal Ballooning Angioplasty Receives: Procedure: transluminal ballooning |
| Control | Active comparator | currently existing therapies for the treatment of vasospasm Receives: Other: currently existing therapies for the treatment of vasospasm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startOct 2000
- Primary completionSep 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Jan Paul Muizelaar, MD, PhD, Principal investigator, Professor and Chairman, Department of Neurological Surgery, University of California, DavisJonathan Hartman, MD, Principal investigator, Interventional Neuroradiologist, University of California, DavisMarike Zwienenberg, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282893
- Sponsor's protocol ID
- 200311385
- Other IDs
- R01NS038484
- Status last verified
- Mar 2014
- First submitted
- 26 Jan 2006
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18420953
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Prophylaxis of Aneurysmal Vasospasm
- ClinicalTrials.gov ID
- NCT00282893
- Acronym / sponsor ID
- 200311385
- Keywords
- aneurysm, vasospasm, subarachnoid hemorrhage, transluminal ballooning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2000
- Primary completion
- Sep 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pTBA | Experimental | Procedure: transluminal ballooningProphylactic Transluminal Ballooning Angioplasty |
| Control | Active comparator | Other: currently existing therapies for the treatment of vasospasmcurrently existing therapies for the treatment of vasospasm |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transluminal ballooning | Procedure or surgery | pTBA |
| currently existing therapies for the treatment of vasospasm | Other | Control |
Primary outcome
Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Results publication: PubMed 18420953Zwienenberg-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Paul Muizelaar, MD, PhD principal investigator
Professor and Chairman, Department of Neurological Surgery, University of California, Davis
Jonathan Hartman, MD principal investigator
Interventional Neuroradiologist, University of California, Davis
Marike Zwienenberg, MD principal investigator
University of California, Davis
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transluminal ballooning and currently existing therapies for the treatment of vasospasm in people with Aneurysm and Vasospasm, run by University of California, Davis at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00282893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017.