ISRCTN49474281CompletedPhase 3
ational 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
Alder Hey Children's Hospital Foundation Trust (UK)0 sites1,605 target enrollmentStarted: December 17, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,605
Study Overview
Brief Summary
2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/24383496 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31522843 results (added 17/09/2019) 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32238262 results (added 03/04/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36303476/ Post hoc analysis (added 06/02/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
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
Investigators
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