Intraoperative, intracisternal tissue plasminogen activator for the prevention of vasospasm

Completed

Phase N/A Results

Trial Description

To study the possible role of intracisternally administered fibrinolytic agent recombinant tissue plasminogen activator (rt-PA) in preventing delayed onset cerebral vasospasm following aneurysmal subarachnoid hemorrhage (SAH).

Interventions

Trial Design

Randomized, double-blind, placebo-controlled trial of 100 patients at 9 centers.

Patient Involvement

Patients were randomized to receive a single 10 ml intraoperative injection of either vehicle buffer solution or rt-PA (1 mg/ml) into the opened basal subarachnoid cisterns immediately following aneurysm clipping. 15 minutes after intracisternal injection of treatment solution, the subarachnoid space was irrigated with >= 1.0 liters of saline. All patients received nimodipine, 60 mg by mouth every four hours for at least 14 days but no more than 21 days following SAH. Patients received hemodilution, hypervolemia, induced hypertension and transluminal balloon angioplasty, as necessary, for symptomatic vasospasm. Patients were followed for 3 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Angiographic vasospasm 7 to 11 days after SAH.
Secondary Mortality and overall outcome at 3 months; symptomatic vasospasm <= 14 days after SAH; neurological worsening and cause of the worsening; evidence of clot clearance on CT scan; TCD velocities; need for hemodilution, hypervolemia, hypertension and transluminal balloon angioplasty to reverse symptomatic vasospasm.