SVASONA Trial
Ensayo clínico multicéntrico aleatorizado, que propone investigar si la combinación de una válvula programable y una unidad gravitatoria (proGAV, Aesculap / Miethke, Alemania) es capaz de reducir la incidencia de hiperdrenaje,y mejorar los resultados en comparación con una válvula programable convencional (Medos-Codman , Johnson & Johnson, Alemania). 1) 2) 3) 4)
1)
Meier U, Stengel D, Müller C, Fritsch MJ, Kehler U, Langer N, Kiefer M, R, Schuhmann MU, Speil A, Weber F, Remenez V, Rohde V, Ludwig HC, Lemcke J.Predictors of subsequent overdrainage and clinical outcomes after ventriculoperitoneal shunting for idiopathic normal pressure hydrocephalus.Neurosurgery. 2013 Dec;73(6):1054-60. doi: 10.1227/NEU.0000000000000155. PubMed PMID: 24257332.
2)
Lemcke J, Meier U, Müller C, Fritsch MJ, Kehler U, Langer N, Kiefer M, Eymann
R, Schuhmann MU, Speil A, Weber F, Remenez V, Rohde V, Ludwig HC, Stengel D.
Safety and efficacy of gravitational shunt valves in patients with idiopathic
normal pressure hydrocephalus: a pragmatic, randomised, open label, multicentre
trial (SVASONA). J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):850-7. doi:
10.1136/jnnp-2012-303936. Epub 2013 Mar 1. PubMed PMID: 23457222; PubMed Central
PMCID: PMC3717598.
3)
Lemcke J, Meier U, Müller C, Fritsch M, Kiefer M, Eymann R, Kehler U, Langer
N, Schuhmann MU, Speil A, Weber F, Remenez V, Rohde V, Ludwig HC, Stengel D. On
the method of a randomised comparison of programmable valves with and without
gravitational units: the SVASONA study. Acta Neurochir Suppl. 2012;114:243-6.
doi: 10.1007/978-3-7091-0956-4_48. PubMed PMID: 22327702.
4)
Lemcke J, Meier U, Müller C, Fritsch M, Eymann R, Kiefer M, Kehler U, Langer
N, Rohde V, Ludwig HC, Weber F, Remenez V, Schuhmann M, Stengel D. Is it possible
to minimize overdrainage complications with gravitational units in patients with
idiopathic normal pressure hydrocephalus? Protocol of the randomized controlled
SVASONA Trial (ISRCTN51046698). Acta Neurochir Suppl. 2010;106:113-5. doi:
10.1007/978-3-211-98811-4_19. PubMed PMID: 19812931.