Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SC 9606
Study information
Scientific title
Central venous catheter use in paediatric oncology patients in the UK: mechanical problems
Acronym
Study hypothesis
Added 07/08/2009:
The aim of this trial is to determine the optimum technique for ensuring central venous catheters are not subject to mechanical failure (eg. falling out).
As of 07/08/2009 this record was extensively updated. All updates can be found under the relevant field with the above update date.
Ethics approval
Not provided at time of registration
Study design
Multicentre 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 below to request a patient information sheet
Condition
Miscellaneous paediatric cancer
Intervention
1. Group A: Skin only exit site suture on central venous catheter
2. Group B: Skin and line exit site suture on central venous catheter
Mechanical problems include dislodgment and migration documented in the post operative period.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Added 07/08/09:
1. Mechanical failure rate.
2. Correlation with exit suture type and whether additional procedures (eg. bone marrow, lumbar puncture) are undertaken at the same anaesthetic as the central venous line insertion.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
15/12/1996
Overall trial end date
31/12/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient under the care of a UKCCSG centre
2. Patients must have cancer
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients without cancer who require a central venous catheter for treatment of immunodeficiency, chronic antibiotic administration, dialysis or total parenteral nutrition are excluded.
Recruitment start date
15/12/1996
Recruitment end date
31/12/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Cancer Research UK (CRUK) (UK)
Sponsor details
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
United Kingdom Children's Cancer Study Group (UKCCSG)
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
Basic results (scientific)
Publication list