Contact information
Type
Scientific
Primary contact
Prof Ullrich Meier
ORCID ID
Contact details
Department of Neurosurgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
ullrich.meier@ukb.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SVASONA Protocol Version 1.3 August 2006 (IRB approved)
Study information
Scientific title
Acronym
SVASONA
Study hypothesis
Combined draining with a shunt valve and a shunt assistant decreases the rate of overdrainage (defined as a composite of clinical signs and symptoms, radiological findings, and therapeutic actions [i.e., pressure adjustment and/ or surgical revisions] taken to resolve the condition) from 25% to 10% comparing with a shunt valve alone six months after index surgery.
Ethics approval
The trial was approved by the Institutional Review Board of the Charite University Medical Centre, Berlin (Germany) on 6th November 2006 (ref: EA1/165/06).
Study design
Open-label, pragmatic randomised controlled multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Idiopathic Normal-Pressure Hydrocephalus (INPH) in adults
Intervention
Experimental arm: ProGAV P3 (PGV, Miethke, Germany) Adjustable/Gravitational Valve
Control arm: Medos-Codman Programmable Valve System (CHPV, Codman Johnson & Johnson, Germany)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Composite measure of:
1. Clinical signs and symptoms suggestive of overdrainage (e.g., headache, vomiting, dizziness)
2. Imaging results (e.g., subdural haematoma, slit-ventricle syndrome)
3. Therapeutic interventions to resolve overdrainage
Secondary outcome measures
1. INPH outcome scales and Recovery Rate
2. 12-item Short-Form health survey (SF-12)
3. Evans-Index
4. Complication rates
5. Adverse Events (AE)
6. Serious Adverse Events (SAE)
Overall trial start date
01/02/2007
Overall trial end date
01/08/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female subjects more than 18 years
2. High probability of Idiopathic Normal-Pressure Hydrocephalus (INPH), according to published guidelines and locally established protocols
3. The diagnosis will include clinical signs and symptoms (Hakim's triad), the findings from lumbal infusion and tap tests, intermittent drainage, and Computed Tomography (CT) results
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
250 patients with adaptive O'Brien-Fleming design
Participant exclusion criteria
1. Secondary Normal-Pressure Hydrocephalus (NPH) to inflammation
2. Tumour
3. Post-traumatic states
4. Contraindications for surgery (e.g., severe underlying diseases, florid infections)
5. Severe dementia
Recruitment start date
01/02/2007
Recruitment end date
01/08/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Neurosurgery
Berlin
12683
Germany
Sponsor information
Organisation
B. Braun Melsungen AG (Germany)
Sponsor details
Carl-Braun-Strasse 1
Melsungen
34212
Germany
info@bbraun.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Investigator-initiated and funded trial. Additional external funding for trial logistics and travel will be provided by Braun-Aesculap (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19812931
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23457222
Publication citations
-
Protocol
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, 113-115, doi: 10.1007/978-3-211-98811-4_19.
-
Results
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. Psychiatr., 2013, 84, 8, 850-857, doi: 10.1136/jnnp-2012-303936.