Plain English Summary
Background and study aims:
Two new devices have been introduced to try to reduce shunt infection; Bactiseal and Silverline shunts. This study will compare these new shunts to standard shunts. Our goal is to establish which provides most protection against infection and to ensure standardisation of care.
Who can participate?
Children and adults with newly diagnosed hydrocephalus.
What does the study involve?
Patients will be randomly chosen to receive either standard, Bactiseal or Silverline shunts. The patient will have a follow up every three months via the telephone and a questionnaire by post.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients requiring this treatment as they will potentially have reduced shunt infection.
The main risk of infection is complications for the patients which can leads to prolonged hospital stay, multiple operations and reduced IQ.
Where is the study run from?
Alder Hey Childrens Hospital NHS Foundation Trust.
When is study starting and how long is it expected to run for?
Recruitment will start in early 2013, for 2 years. Patients will be followed up for a maximum of 2.5 years.
Who is funding the study?
National Institute of Health Research Health Technology Assessment Programme
Who is the main contact?
Mr Tom Kearns
thomas.kearns@liv.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 2.0; HTA 10/104/30
Study information
Scientific title
National three-arm, double blind multi-centre randomised controlled trial comparing Bactiseal (antibiotic-impregnated), Silverline (silver-impregnated) and standard (non-impregnated) VPS in patients with newly diagnosed hydrocephalus undergoing insertion of their first permanent shunt
Acronym
BASICS
Study hypothesis
Shunt failure due to infection has plagued this neurosurgical advance ever since it was developed. The incidence of shunt infection varies markedly in the literature from 3-27% (2-6) and is higher in certain groups, e.g. neonates and children under 1 year old, patients treated with a previous temporary external ventricular drain (EVD). Episodes of shunt infection have a significant impact on patients and the NHS and require prolonged inpatient hospitalisation, additional surgery to remove the infected hardware, placement of a temporary EVD, intravenous and intrathecal antibiotics, and further surgery to place a new shunt once the infection has been treated. Other clinical consequences of infection including epilepsy, reduced IQ and loculation have often been reported but never formally studied in the context of a prospective clinical trial. This trial thus addresses the primary question of which shunt catheter is most effective in reducing shunt infection and also has secondary questions addressing the consequences of infection in a clinical and financial context.
More details can be found here: http://www.hta.ac.uk/project/2902.asp
Ethics approval
Not provided at time of registration
Study design
Three-arm multi-centre phase III randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Newly diagnosed hydrocephalus
Intervention
We will randomly allocate patients to a standard non impregnated ventriculoperitoneal shunt (VPS), a
Silverline (Silver impregnated) VPS or a Bactiseal (antiobiotic impregnated) VPS on a ratio of 1:1:1. All VPS
used for the trial are CE marked medical devices being used for their intended purpose.
Intervention type
Device
Phase
Phase III
Drug names
Primary outcome measure
Early infection (within 6 months) following insertion of the first de novo VPS
Secondary outcome measures
1. The proportion of delayed VPS infections (occurring > 6 months following de novo insertion)
2. Which organisms and their resistance/sensitivities, subsequently infect these three alternative VPS
3. The clinical impact of each VPS infection
4. The infection rate following the first (non-infected) clean VPS revision for mechanical failure
5. The cost-effectiveness and health economics of antibiotic and silver impregnated VPS compared to standard VPS
6. The diagnostics of suspected shunt infections through molecular diagnostic approaches
Overall trial start date
01/03/2013
Overall trial end date
01/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Newly diagnosed hydrocephalus of any aetiology (including idiopathic intracranial hypertension)
2. VPS is the primary treatment option
3. Clear CSF sample at the time of shunt insertion
3.1. Failed primary endosopic third ventriculostomy allowed
3.2. Previous indwelling ventricular access device (e.g. Ommaya or Rickham reservoir or similar) allowed
3.3. Previous indwelling EVD allowed
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1200
Participant exclusion criteria
1. Previous indwelling VPS
2. Active and on-going CSF or peritoneal infection
3. Multi-loculated hydrocephalus requiring multiple VPS or neuro-endoscopy
4. Ventriculo-atrial or ventriculo-pleural shunt planned
5. Allergy to antibiotics associated with the antibiotic shunt
Recruitment start date
01/03/2013
Recruitment end date
01/08/2013
Locations
Countries of recruitment
Ireland, United Kingdom
Trial participating centre
Alder Hey Childrens NHS Foundation Trust
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Alder Hey Children's Hospital Foundation Trust (UK)
Sponsor details
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5673
Katherine.jopson@alderhey.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme: 10/104/30
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24383496
Publication citations
-
Protocol
Jenkinson MD, Gamble C, Hartley JC, Hickey H, Hughes D, Blundell M, Griffiths MJ, Solomon T, Mallucci CL, The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol., Trials, 2014, 15, 4, doi: 10.1186/1745-6215-15-4.