Acta neurochirurgica. Supplement
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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.
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialOn the method of a randomised comparison of programmable valves with and without gravitational units: the SVASONA study.
The supremacy of low-pressure valves (LPV) in the therapy of patients with idiopathic normal pressure hydrocephalus (iNPH) has been proven by the Dutch NPH study. The downside of LPVs is the high rate of overdrainage complications. In the meantime gravitational units have been developed with the objective of minimising overdrainage complications. Do these gravitational units allow the same favourable outcomes as in the Dutch NPH study without overdrainage complications? The goal of this prospective randomised controlled multicentre trial is to compare the rate of overdrainage complications after shunt surgery with programmable valves with or without a gravitational unit. ⋯ The design of the SVASONA study was developed to be able to confirm the primary hypothesis. Thus, the method of the study should solve the dilemma of the Dutch NPH study by the randomised comparison of LPVs with and without gravitational units.
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Acta Neurochir. Suppl. · Jan 2012
Randomized Controlled TrialA microdialysis study of oral vigabatrin administration in head injury patients: preliminary evaluation of multimodality monitoring.
We assessed the feasibility of administering a neuroprotective drug, vigabatrin (VGB; gamma-vinyl-gamma-aminobutyric acid) with multimodality monitoring, including cerebral microdialysis, in severe head injury patients, to measure surrogate endpoints and blood-brain barrier (BBB) penetration. ⋯ Multimodality monitoring, including cerebral microdialysis, is feasible for studying surrogate endpoints following drug administration. VGB crosses the BBB, leading to modest increases in extracellular GABA. Further analyses are ongoing. Microdialysis may assist the development of neuroprotective agents by determining penetration into extracellular fluid of the brain.