Acta neurochirurgica. Supplement
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Acta Neurochir. Suppl. · Jan 2013
Randomized Controlled Trial Multicenter StudyRandomised trial of clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid hemorrhage undergoing surgical clipping (CONSCIOUS-2).
We report here results of a randomized, double-blind, placebo-controlled study ( http://www. ClinicalTrials.gov , NCT00558311) that investigated the effect of clazosentan (5 mg/h, n = 768) or placebo (n = 389) administered for up to 14 days in patients with aneurysmal subarachnoid hemorrhage (SAH) repaired by surgical clipping. The primary endpoint was a composite of all-cause mortality, new cerebral infarction or delayed ischemic neurological deficit due to vasospasm, and rescue therapy for vasospasm. ⋯ Lung complications, anemia and hypotension occurred more frequently with clazosentan. Mortality (week 12) was 6% in both groups. The results showed that clazosentan nonsignificantly decreased mortality/vasospasm-related morbidity and nonsignificantly increased poor functional outcome in patients with aneurysmal SAH undergoing surgical clipping.
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Acta Neurochir. Suppl. · Jan 2013
Randomized Controlled Trial Multicenter StudyDevelopment of nicardipine prolonged-release implants after clipping for preventing cerebral vasospasm: from laboratory to clinical trial.
We have developed a drug delivery system using a vasodilating drug that can be implanted intracranially at the time of surgery for aneurysm clipping, without systemic side effects or side effects associated with long-term intrathecal drug administration. We started our project on 1994 for making a slowly releasing drug delivery system in vitro because cerebral vasospasm occurs 4-14 days following subarachnoid hemorrhage (SAH). A rod-shaped pellet containing 1 mg of nicardipine for animal study was prepared by heat compression. ⋯ Vasospasm was completely prevented in the arteries by placing NPRIs adjacent to the arteries during surgery. No complications were experienced. We have performed three studies (a single-center study with consecutive patients; a single-center, randomized, double-blind trial; and a multicenter cooperative study) and have proved that implantation of NPRIs reduces the incidence of cerebral vasospasm and DINDs and improves clinical outcome after SAH.
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Acta Neurochir. Suppl. · Jan 2013
Randomized Controlled TrialGlobal cerebral atrophy after subarachnoid hemorrhage: a possible marker of acute brain injury and assessment of its impact on outcome.
There is a correlation between poor neuropsychological outcome and focal regions of atrophy in patients with subarachnoid hemorrhage (SAH). No study has investigated the impact of global brain atrophy on outcome after SAH. In other neurological disorders, such as multiple sclerosis, a correlation has been found between global atrophy and outcome. ⋯ Relationships were modeled using univariate and multivariate analysis. Age, female gender, and higher body temperature during the patient's stay in the intensive care unit were significantly correlated with brain atrophy. Greater brain atrophy significantly correlated with poor outcome (modified Rankin scale), more severe neurological deficits on the National Institute of Health Stroke Scale (NIHSS), and poorer health status (EQ-5D).
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialThe effect of intraventricular thrombolysis in combination with low-frequency head motion after severe subarachnoid hemorrhage: interim analysis of safety, clot clearance rate and delayed cerebral ischemia.
The current clinical prospective randomized phase II study was initiated in order to analyze the effect of enhanced washout by discontinuous intraventricular thrombolysis in combination with low-frequency head-motion therapy on side effects, clot clearance rate, cerebral vasospasm and clinical outcome after severe subarachnoid hemorrhage (SAH). ⋯ The present study demonstrates that a combination of intraventricular thrombolysis and lateral rotational therapy is not associated with a higher complication rate. Furthermore, the therapy leads to a significant acceleration of the clot clearance rate.
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialConservative versus surgical management of idiopathic normal pressure hydrocephalus: a prospective double-blind randomized controlled trial: study protocol.
There is no level I evidence to indicate whether placement of a shunt is effective in the management of idiopathic normal pressure hydrocephalus (INPH), because no trial has as yet compared the placement of a shunt versus no shunt in a randomized controlled manner. We started recruiting patients into a prospective double-blind randomized controlled study aiming to provide class I evidence supporting or refuting the role of surgical management in INPH. Inclusion criterion was the diagnosis of probable INPH plus objective improvement of walking speed following 72 h of extended lumbar drainage. ⋯ Primary end point was to be an improvement in gait. Secondary end points were improvement in mental function or urinary function and incidence of complications. Final results are expected mid 2011.