Condition category
Circulatory System
Date applied
12/09/2005
Date assigned
20/12/2005
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Nicole Keong

ORCID ID

Contact details

Box 166
Department of Neurosurgery
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Cambridge LREC 04/Q0108/247

Study information

Scientific title

Silver Impregnated Line Versus EVD Randomised Trial and Cerebrospinal Fluid Infection from the use of External Ventricular Drains

Acronym

SILVER Trial

Study hypothesis

Silver impregnated lines (external ventricular drains with silver lining) cause fewer cerebrospinal fluid (CSF) infections than plain standard EVD catheters.

Please note that as of 19/04/10 this trial has been extensively updated. All updates may be found in the relevant field with the above update date. Please also note that the anticipated start and end dates of the trial 01/07/05 to 31/07/07 have been changed to the actual start and end dates 01/06/05 to 31/09/09. A second site, Southampton, also joined the trial after the last recorded update (03/12/07)

Ethics approval

Added 19/04/10
1. Cambridge Local Research Ethics Committee approved in February 2005 (ref: 04/Q0108/247)
2. Southampton Local Research Ethics Committee approved in November 2006

Study design

Double blind randomised plain controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Information sheets and consent forms as approved by local ethics committees

Condition

Cerebrospinal fluid infection, external ventricular drains for raised intracranial pressure, ventriculomegaly or hydrocephalus

Intervention

Current information as of 19/04/10:
Participants were randomised to receive either a silver impregnated EVD or a plain standard EVD for the duration of their EVD requirement to treat raised intracranial pressure, hydrocephalus or ventriculomegaly.

Initial information at time of registration:
Silver impregnated lines (external ventricular drains with silver lining) versus plain standard EVDs.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current information as of 19/04/10:
CSF infection as defined by organisms seen on gram stain or grown on culture during the EVD period

Initial information at time of registration
CSF infection confirmed by culture of organisms

Secondary outcome measures

Current information as of 19/04/10:
1. Number of EVD replacements
2. Duration of EVD placement
3. Antibiotic treatment required for CSF infection (confirmed or suspected)
4. Total time from admission to discharge
5. Permanent ventriculoperitoneal (VP) shunt required at 6 months
6. Clinical outcome at discharge (Glasgow Coma Score)

Initial information at time of registration:
1. Number of EVD replacements
2. Duration of EVD placement
3. Antibiotic treatment required for CSF infection (confirmed or suspected)
4. Total time from admission to discharge
5. Permanent ventriculoperitoneal (VP) shunt required
6. Clinical outcome at discharge (Glasgow Coma Score)

Overall trial start date

01/06/2005

Overall trial end date

30/09/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 19/04/10:
All patients 17 years and over requiring an EVD for management of their intracranial pathology referred to Cambridge University Hospitals NHS Foundation Trust, Cambridge and Wessex Neurological Centre, Southampton

Initial information at time of registration:
All patients requiring an EVD for management of their intracranial pathology referred to Cambridge University Hospitals NHS Foundation Trust

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140 in each arm (2 arms) - total 280

Participant exclusion criteria

1. Patients with a known allergy to silver
2. Patients who are pregnant
3. The presence of infection or dermatitis at the catheter insertion site
4. Known cerebrospinal fluid (CSF) infection (gram-stain or culture of organisms)
5. A previous EVD placement within the previous 30 days
6. Refractory coagulopathy
7. Currently the trial is only open to patients who are 17 years or above

Recruitment start date

01/06/2005

Recruitment end date

30/09/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 166, Department of Neurosurgery
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Box 166
Department of Neurosurgery
Cambridge University Hospitals NHS Foundation Trust
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Current information as of 19/04/10:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The trial has been run as a clinical investigation involving two neurosurgical units - Cambridge University Hospitals NHS Foundation Trust and Wessex Neurological Centre, Southampton. The trial EVDs were cost-neutral to both trusts as compared to non-study catheters. There was no cost benefit to either the units or the investigators

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Initial information at time of registration:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The trial is run as a clinical investigation by Cambridge University Hospitals NHS Foundation Trust . The trial EVDs are purchased at the same price as the EVDs currently in clinical use. There is no cost benefit to the investigators.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

1. Proceedings of the 155th meeting of the Society of British Neurological Surgeons
British Journal of Neurosurgery. April 2010, Vol. 24, No. 2, Pages 108-147.
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22811084

Publication citations

  1. Results

    Keong NC, Bulters DO, Richards HK, Farrington M, Sparrow OC, Pickard JD, Hutchinson PJ, Kirkpatrick PJ, The SILVER (Silver Impregnated Line Versus EVD Randomized trial): a double-blind, prospective, randomized, controlled trial of an intervention to reduce the rate of external ventricular drain infection., Neurosurgery, 2012, 71, 2, 394-403; discussion 403-4, doi: 10.1227/NEU.0b013e318257bebb.

Additional files

Editorial Notes