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 |
| Secondary identifying numbers | SVASONA Protocol Version 1.3 August 2006 (IRB approved) |
- 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
Scientific
Department of Neurosurgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
| ullrich.meier@ukb.de |
Study information
| Study design | Open-label, pragmatic randomised controlled multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/02/2007 |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 250 patients with adaptive O'Brien-Fleming design |
| 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
12683
Germany
Sponsor information
B. Braun Melsungen AG (Germany)
Industry
Industry
Carl-Braun-Strasse 1
Melsungen
34212
Germany
| info@bbraun.com | |
| Website | http://www.bbraun.de/ |
"ROR" |
https://ror.org/04nxj7050 |
Funders
Funder type
Industry
Investigator-initiated and funded trial. Additional external funding for trial logistics and travel will be provided by Braun-Aesculap (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/04/2010 | Yes | No | |
| Results article | results | 01/08/2013 | Yes | No |
