Central venous catheter use in paediatric oncology patients in the UK: mechanical problems

ISRCTN ISRCTN18595444
DOI https://doi.org/10.1186/ISRCTN18595444
Protocol serial number SC 9606
Sponsor Cancer Research UK (CRUK) (UK)
Funders Cancer Research UK (CRUK) (UK), United Kingdom Children's Cancer Study Group (UKCCSG)
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
03/03/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

- -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study designInterventional
Study designMulticentre randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleCentral venous catheter use in paediatric oncology patients in the UK: mechanical problems
Study objectivesAdded 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMiscellaneous paediatric cancer
Intervention1. 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/12/2000

Eligibility

Participant type(s)Patient
Age groupChild
SexAll
Key inclusion criteria1. Patient under the care of a UKCCSG centre
2. Patients must have cancer
Key exclusion criteriaPatients without cancer who require a central venous catheter for treatment of immunodeficiency, chronic antibiotic administration, dialysis or total parenteral nutrition are excluded.
Date of first enrolment15/12/1996
Date of final enrolment31/12/2000

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes