Journal of neurosurgery
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Journal of neurosurgery · Mar 1997
Randomized Controlled Trial Multicenter Study Clinical TrialA randomized, double-blind, vehicle-controlled trial of tirilazad mesylate in patients with aneurysmal subarachnoid hemorrhage: a cooperative study in North America.
To test the safety and efficacy of tirilazad mesylate, a nonglucocorticoid 21-aminosteroid, in improving the outcome of patients with aneurysmal subarachnoid hemorrhage (SAH), 902 patients were enrolled in a prospective randomized, double-blind, vehicle-controlled trial at 54 North American neurosurgical centers. Five patients were excluded prior to receiving any study drug. Of 897 patients who received at least one dose of study medication, 300 received a placebo containing a citrate vehicle, 298 received 2 mg/kg per day tirilazad, and 299 received 6 mg/kg per day tirilazad, all administered intravenously beginning within 48 hours of the SAH and continuing through 10 days posthemorrhage. ⋯ Tirilazad was well tolerated at both dose levels. Tirilazad mesylate at dosage levels of up to 6 mg/kg per day for 8 to 10 days following SAH did not improve the overall outcome in patients with aneurysmal SAH in this trial. The differences in the efficacy of tirilazad in this trial and a previously reported trial in Europe, Australia, and New Zealand, in which dosage levels of tirilazad of 6 mg/kg per day reduced mortality rates and increased good recovery, may be a result of differences in admission characteristics of the patients and/or differences in management protocols, including the use of anticonvulsant medications.
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Journal of neurosurgery · Mar 1997
Multicenter Study Clinical TrialGuglielmi detachable coil embolization of acute intracranial aneurysm: perioperative anatomical and clinical outcome in 403 patients.
From December 1990 to July 1995, the investigators participated in a prospective clinical study to evaluate the safety of the Guglielmi detachable coil (GDC) system for the treatment of aneurysms. This report summarizes the perioperative results from eight initial interventional neuroradiology centers in the United States. The report focuses on 403 patients who presented with acute subarachnoid hemorrhage from a ruptured intracranial aneurysm. ⋯ Seven deaths were related to technical complications (1.74%) and 18 (4.47%) to the severity of the primary hemorrhage. The findings of this study demonstrate the safety of the GDC system for the treatment of ruptured intracranial aneurysms in anterior and posterior circulations. The authors believe additional randomized studies will further identify the role of this technique in the management of acutely ruptured incranial aneurysms.