Title: The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised controlled trial (The BASICS trial)
Funder: Department of Health and Social Care

Abstract: Design: Three-arm, multi-centre phase III randomised controlled trial. This will be an open trial. The colour of the shunts differs so surgeons cannot be blinded. The patient will be blinded to VPS type and this will not be recorded in the case notes. Setting: In-patients being treated in Regional Neurosurgery Units in the UK and Ireland. Target population: Children and adults with newly diagnosed hydrocephalus requiring a VPS (Exclusions: previous VPS, active cerebrospinal / peritoneal infection, complex hydrocephalus, ventriulo-atrial or pleural shunts) Health technologies being assessed: a) Bactiseal® antibiotic-impregnated VPS versus standard VPS (comparator) b) Silverline® silver-impregnated VPS versus standard VPS (comparator) c) Secondary comparison of Bactiseal versus Silverline VPS Measurement of costs and outcomes: Primary outcome: Time to first VPS infection Secondary outcomes: • Time to shunt failure of any cause • Reason for shunt failure (infection, mechanical, patient, other) • Types of bacterial VPS infection (organism, antibiotic resistance) • Time to VPS failure following first clean revision • Incremental cost per VPS failure • Incremental cost per QALY gained Health economic analysis: Health economic analysis will adopt the perspective of the NHS. Costs will include those of the catheters, duration of intensive care stay and hospital admission, antibiotic treatment, and contact with health professionals. Resource use will be based on entries made in CRFs; complemented with HES data. The approach will follow the procedures of the HTA-funded CATCH trial (standard operating procedure currently being drafted), and has the benefit of tracking patients according to their NHS number. Given that the economic question under consideration is one of technical efficiency (i.e. which VPS is most cost-effective), we shall approach this as a cost-effectiveness analysis, based on the incremental cost per shunt failure averted. Secondary economic outcomes will include: (i) incremental cost per shunt infection avoided; and (ii) incremental cost per QALY gained. Stratified cost-effectiveness analyses will be conducted on important, pre-specified patient subgroups (including neonates, patients under 1 year old, patients with a previous EVD).

Lay abstract: Hydrocephalus (commonly known as “water on the brain”) is a condition that can affect all age groups from babies to the elderly. In hydrocephalus, there is an accumulation of the normal brain fluid within the fluid cavities (ventricles) of the brain. Untreated, hydrocephalus can be life-threatening. The commonest treatment involves an operation to insert a tube into the swollen ventricles to drain off the excess fluid. This is called a ventriculoperitoneal shunt (VPS). In the UK, 3000-3500 shunt operations are performed each year. One of the main risks of a shunt operation is infection (surgical meningitis), which results in the need for further surgery, antibiotic treatment and prolonged hospitalisation It can have lifelong consequences, affect intellectual function and can be life-threatening. Two new devices have been introduced to try to reduce shunt infection; antibiotic-impregnated (Bactiseal) and silver-impregnated (Silverline) shunts. This study will compare these new shunts to standard shunts in a study called a randomised multi-centre controlled trial. There has never been a similar trial to compare these shunts on such a scale. This will be a national trial recruiting 1200 participants from specialist neurosurgical units. Our goal is to establish which VPS provides most protection against infection and the the long term goal thereafter is to inform NHS policy and to ensure standardisation of care and infection rates across the country. In addition, we will be exploring the impact that infection could have on participants in terms of hospital stay, post-operative complications and the potential cost to participants and the NHS. This team is well place to carry out this research and already has experience of projects in similar settings. The conduct of the trial does not incur additional costs to the NHS, however the number of patients to be recruited and followed-up requires provision of Research Nurses within all recruiting centres.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: NEUROLOGICAL