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.
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Journal of neurosurgery · May 1996
Randomized Controlled Trial Multicenter Study Clinical TrialEffects of a hydroxyl radical scavenger on delayed ischemic neurological deficits following aneurysmal subarachnoid hemorrhage: results of a multicenter, placebo-controlled double-blind trial.
A water-soluble, novel synthetic compound, AVS ((+/-)-N, N'-propylenedinicotinamide; nicaraven) has no demonstrable vasoactive properties but scavenges hydroxyl radicals in aqueous environmental conditions at neutral pH. Based on the results of preceding experimental and clinical studies showing marked ameliorative effects of AVS on cerebral vasospasm and ischemic brain damage, a multicenter, placebo-controlled double-blind clinical trial was undertaken to verify its beneficial effects on delayed ischemic neurological deficits (DINDs) due to vasospasm and on the overall outcome of patients with subarachnoid hemorrhage (SAH). A total of 162 patients with SAH who had Glasgow Coma Scale scores between 7 and 15 on admission were enrolled in the trial. ⋯ The Glasgow Outcome Scale (GOS) score at 1 month was significantly improved by AVS (p < 0.05, U-test). At 3 months, the difference in the GOS scores between the groups became marginal on U-tests (p < 0.10), but the percentage of good outcome tended to increase, with a relative increase of 20.3% (AVS 76.3%, placebo 63.4%; p < 0.10, chi-square test), and the cumulative incidence of death was significantly reduced (p < 0.05, log-rank test). No significant adverse reaction attributable to treatment was observed. the usefulness of AVS in therapy for SAH is strongly indicated by the fact that the agent significantly ameliorated DINDs, leading to a marked improvement in the GOS scores at 1 month, as well as a reduction in the cumulative incidence of death by 3 months.
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Journal of neurosurgery · Feb 1996
Randomized Controlled Trial Multicenter Study Clinical TrialRandomized, double-blind, vehicle-controlled trial of tirilazad mesylate in patients with aneurysmal subarachnoid hemorrhage: a cooperative study in Europe, Australia, and New Zealand.
Tirilazad mesylate, a nonglucocorticoid 21-aminosteroid, has been shown in experimental models to reduce vasospasm following subarachnoid hemorrhage (SAH) and to reduce infarct size from focal cerebral ischemia. To test whether treatment with tirilazad would reduce ischemic symptoms from vasospasm and improve overall outcome in patients with ruptured aneurysms, a prospective randomized, double-blind, vehicle-controlled trial was conducted at 41 neurosurgical centers in Europe, Australia, and New Zealand. One thousand twenty-three patients were randomly assigned to receive 0.6, 2, or 6 mg/kg per day of intravenously administered tirilazad or a placebo containing the citrate vehicle. ⋯ There were no material differences between the outcomes in the groups treated with 0.6 and 2 mg/kg tirilazad per day and the group treated with vehicle. Tirilazad was well tolerated at all three dose levels. These observations suggest that tirilazad mesylate, at a dosage of 6 mg/kg per day, is safe and improves overall outcome in patients (especially in men) who have experienced an aneurysmal SAH.
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Journal of neurosurgery · Nov 1995
Randomized Controlled Trial Multicenter Study Clinical TrialLong-term prognosis and effect of endarterectomy in patients with symptomatic severe carotid stenosis and contralateral carotid stenosis or occlusion: results from NASCET. North American Symptomatic Carotid Endarterectomy Trial (NASCET) Group.
The purpose of this study was to examine how the prognosis of patients who presented with a recent ischemic event referable to a 70% to 99% stenosis of one carotid artery (ipsilateral) was altered by stenosis and occlusion of the contralateral carotid artery. The benefit of performing carotid endarterectomy on the recently symptomatic artery, in the presence of contralateral artery disease, was also examined. A total of 659 patients were grouped into one of three categories according to the extent of stenosis in the contralateral carotid artery: less than 70% (559 patients), 70% to 99% (57 patients), and occlusion (43 patients). ⋯ Regression analyses indicated that the results were not affected by other risk factors. An occluded contralateral carotid artery significantly increased the risk of stroke associated with a severely stenosed ipsilateral carotid artery. Despite higher perioperative morbidity in the presence of an occluded contralateral artery, the longer-term outlook for patients who had endarterectomy performed on the recently symptomatic, severely stenosed ipsilateral carotid artery was considerably better than for medically treated patients.