Acta neurochirurgica. Supplement
-
Acta Neurochir. Suppl. · Jan 2011
Multicenter Study Clinical TrialClinical trial of nicardipine prolonged-release implants for preventing cerebral vasospasm: multicenter cooperative study in Tokyo.
since October 1999, nicardipine pellets (NP) have been used to prevent vasospasm in patients with subarachnoid hemorrhage (SAH). We started a multicenter cooperative study on Jan 1, 2007, and 136 patients in six hospitals were enrolled to this trial in 2 years. The incidence of cerebral vasospasm and outcome were examined in these patients. ⋯ the incidence of cerebral vasospasm in this multicenter trial is similar to that of our first trial performed in a single center.
-
Acta Neurochir. Suppl. · Jan 2011
Randomized Controlled Trial Multicenter StudyClazosentan: prevention of cerebral vasospasm and the potential to overcome infarction.
Cerebral vasospasm is a common complication occurring after aneurysmal subarachnoid hemorrhage (SAH). It is recognized as a leading preventable cause of morbidity and mortality in this patient group, but its management is challenging, and new treatments are needed. Clazosentan is an endothelin receptor antagonist designed to prevent endothelin-mediated cerebral vasospasm. ⋯ Clazosentan reduced angiographic vasospasm dose-dependently relative to placebo with a maximum risk reduction of 65% with the highest dose. Despite this, there was no benefit of clazosentan on the secondary protocol-defined morbidity/mortality endpoint; however, additional post-hoc and modified endpoint analyses provided some evidence for a potential clinical benefit. Two additional large-scale studies (CONSCIOUS-2 and CONSCIOUS-3) are now underway to further investigate the potential of clazosentan to improve long-term clinical outcome.
-
Acta Neurochir. Suppl. · Jan 2011
Multicenter StudyPercutaneous surgical treatment in lumbar spinal stenosis with Aperius-PercLID: indications, surgical technique and results.
Interspinous spacers have recently been used in the treatment of lumbar spinal stenosis. In vitro studies have demonstrated a reduction in facet joint forces by 68% and annulus pressures by 63%. MRI studies have demonstrated increased canal and neural foraminal area after implantation of these devices. ⋯ The average VAS pain score improved from 8.2 to 3.6 (scale of 1 to 10). The overall patient satisfaction rate was 76%. No complications were detected at 6 months' follow-up.
-
Acta Neurochir. Suppl. · Jan 2010
Randomized Controlled Trial Multicenter StudyIs it possible to minimize overdrainage complications with gravitational units in patients with idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled SVASONA Trial (ISRCTN51046698).
Overdrainage is a common complication observed after shunting patients with idiopathic normal-pressure hydrocephalus (iNPH), with an estimated incidence up to 25%. Gravitational units that counterbalance intracranial pressure changes were developed to overcome this problem. We will set out to investigate whether the combination of a programmable valve and a gravitational unit (proGAV, Aesculap/Miethke, Germany) is capable of reducing the incidence of overdrainage and improving patient-centered outcomes compared to a conventional programmable valve (Medos-Codman, Johnson & Johnson, Germany). ⋯ One planned interim analysis for safety and efficacy will be performed halfway through the study. To detect the hypothesized difference in the incidence of overdrainage with a type I error of 5% and a type II error of 20%, correcting for multiple testing and an anticipated dropout rate of 10%, 200 patients will be enrolled. The presented trial is currently recruiting patients, with the first results predicted to be available in late 2008.
-
Acta Neurochir. Suppl. · Jan 2008
Multicenter Study Controlled Clinical TrialPosttraumatic rehabilitation and one year outcome following acute traumatic brain injury (TBI): data from the well defined population based German Prospective Study 2000-2002.
Follow-up examination to review the one-year outcome of patients after craniocerebral trauma with respect to health related quality of life (QoL) and social reintegration. The data are derived from the prospective controlled, well defined population based, multiple centre study that was performed in Germany for the first time in the years 2000-2001 with emphasis on quality management (structural, process, outcome) and regarding the patient's age, physical troubles, and impaired mental-cognitive, neurobehavioral functioning. TBI severity assessment is according to the Glasgow Coma Scale (GCS) score. ⋯ One hundred and sixty patients (= 3.8%) could manage their daily life only partly; 75 TBI (= 87.2%) following mild, 5.8% moderate, and 7% severe TBI. One hundred and sixteen patients could not at all manage their activities in training, at school, or in their jobs (N = 33 MTBI respectively 54%), 6 (= 10%) moderate, and 22 (= 36%) severe TBI. 2.8% of individuals failed when compared with their pre-traumatic situation. TBI severity, patient's age, concomitant organ lesions, and complications influence health related QoL and early social reintegration.