Shunt Valves plus shunt Assistant versus Shunt valves alone for controlling Overdrainage in idiopathic Normal-pressure hydrocephalus in Adults

ISRCTN	ISRCTN51046698
DOI	https://doi.org/10.1186/ISRCTN51046698
Protocol serial number	SVASONA Protocol Version 1.3 August 2006 (IRB approved)
Sponsor	B. Braun Melsungen AG (Germany)
Funder	Investigator-initiated and funded trial. Additional external funding for trial logistics and travel will be provided by Braun-Aesculap (Germany)

Submission date: 28/12/2006
Registration date: 18/05/2007
Last edited: 15/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ullrich Meier
Scientific

Department of Neurosurgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany

Email	ullrich.meier@ukb.de

Study information

Primary study design	Interventional
Study design	Open-label, pragmatic randomised controlled multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SVASONA
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	01/08/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	01/08/2008

Locations

Countries of recruitment

Germany

Study participating centre

Department of Neurosurgery

Berlin
12683
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2013		Yes	No
Protocol article	protocol	01/04/2010		Yes	No