Balloon Prophylaxis of Aneurysmal Vasospasm

Study Overview
=================
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.

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.

Official Title
-----------------
Balloon Prophylaxis of Aneurysmal Vasospasm

Conditions
-----------------
Aneurysm, Vasospasm

Intervention / Treatment
-----------------
* Procedure: transluminal ballooning
* Other: currently existing therapies for the treatment of vasospasm


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pTBA<br>Prophylactic Transluminal Ballooning Angioplasty | Procedure: transluminal ballooning<br> <br> |
| Active Comparator: Control<br>currently existing therapies for the treatment of vasospasm | Other: currently existing therapies for the treatment of vasospasm<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aneurysm, vasospasm, subarachnoid hemorrhage, transluminal ballooning