Aneurysm Clinical Trial
Official title:
Balloon Prophylaxis of Aneurysmal Vasospasm
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.
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.
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