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21 March 2013
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| [ Print-friendly version ] |
| The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trial. |
| ISRCTN | ISRCTN49474281 |
| DOI | 10.1186/ISRCTN49474281 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trial. |
| 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 | The BASICS Trial |
| Serial number at source | Version 2.0 |
| 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 |
| Lay 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 Children’s 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 |
| Ethics approval | Not provided at time of registration |
| Study design | Three-arm, multi-centre phase III randomised controlled trial |
| Countries of recruitment | Ireland, United Kingdom |
| Disease/condition/study domain | Newly diagnosed hydrocephalus |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/03/2013 |
| Anticipated end date | 01/08/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 1200 |
| Interventions |
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. |
| Primary outcome measure(s) | To determine whether antibiotic or silver impregnated ventriculoperitoneal shunt (VPS) reduce early infection (within 6 months) compared to standard VPS in newly diagnosed hydrocephalus following insertion of the first de novo VPS |
| Secondary outcome measure(s) |
1. To determine the proportion of delayed VPS infections (occurring > 6 months following de novo insertion)
2. To determine which organisms and their resistance / sensitivities, subsequently infect these three alternative VPS 3. To assess the clinical impact of each VPS infection 4. To determine the infection rate following the first (non-infected) clean VPS revision for mechanical failure 5. To assess the cost-effectiveness and health economics of antibiotic and silver impregnated VPS compared to standard VPS 6. To improve the diagnostics of suspected shunt infections through molecular diagnostic approaches |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/104/30 |
| Trial website | http://www.basicsstudy.org.uk/ |
| Publications | |
| Contact name | Mr Conor Mallucci |
| Address |
Alder Hey Childrens NHS Foundation Trust
Eaton Road |
| City/town | Liverpool |
| Zip/Postcode | L12 2AP |
| Country | United Kingdom |
| Sponsor | Alder Hey Children's Hospital Foundation Trust (UK) |
| Address | Eaton Road |
| City/town | Liverpool |
| Zip/Postcode | L12 2AP |
| Country | United Kingdom |
| Tel | +44 (0)151 252 5673 |
| Katherine.jopson@alderhey.nhs.uk | |
| Sponsor website: | http://www.alderhey.nhs.uk/ |
| Date applied | 11/12/2012 |
| Last edited | 17/12/2012 |
| Date ISRCTN assigned | 17/12/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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