Balloon Prophylaxis of Aneurysmal Vasospasm

Completed

Phase 2 Results

Trial Description

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.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Patient Involvement

Prior to enrollment, all patients will undergo either cerebral angiography, CT angiography, magnetic resonance angiography (MRA), or any other neuroradiological test sufficient to properly diagnose and grade their aneurysms. Eligible patients will be randomized to receive either TBA or standard management. Standard management will consist of prophylactic volume expansion and hemodilution, nimodipine, magnesium supplementation with a target blood level of 2.2 mg/dL, routine transcranial Doppler (TCD) monitoring, vasopressor-induced hypertension in patients developing delayed ischemic neurological deficits (DIND's), and transluminal balloon angioplasty within 24 hours if deficits persists despite hypertensive hypervolemic hemodilution therapy. The TBP protocol will entail keeping patients intubated for paralysis and anesthesia, anticoagulation with heparin during TBP, digital roadmapping of targeted arteries which will not be dilated beyond normal anatomical confines, and prophylaxis along the entire arterial length. Patients will be followed-up for 6 months, and will be seen by a study clinician at 3 months and 6 months, and if any serious adverse events occur.

Outcomes

Type Measure Time Frame Safety Issue
Primary Dichotomized GOS score (favorable outcome = good recovery/moderate disability; unfavorable outcome = severe disability/vegetative state/death) at 3 months.
Secondary Five-point GOS and extended GOS (GOSE) at 3 months, incidence of symptomatic vasospasm at 14 days, incidence of vasospasm detected by transcranial Doppler (TCD) at 14 days, cost of treatment at 3 months, cost of treatment at 6 months.
Primary Dichotomized Glasgow Outcome Scale (GOS)assessed at 3 months by a blinded evaluator
Secondary 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

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