Condition category
Nervous System Diseases
Date applied
28/12/2006
Date assigned
18/05/2007
Last edited
15/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.bbraun.de/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes