NCT00735813

Brief Summary

Children with cancer need a long term tunnelled central venous catheter (TCVC) for the entire duration of their treatment. TCVCs are locked with heparin when not in use. The most frequent complications of long term TCVC are catheter related blood steam infections. Taurolock is a new lock that is claimed to prevent the formation of luminal biofilm in TCVCs and has been demonstrated to eradicate infected CVCs. In this study the investigators will compare TCVCs locked with heparin with TCVCs locked with Taurolock. Hypothesis: Taurolock will diminish the number of CRBSI in children with cancer compared with children with heparin lock of their CVC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2008

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

4.4 years

First QC Date

August 14, 2008

Last Update Submit

September 4, 2012

Conditions

BacteremiaNeoplasms

Keywords

Catheterization, CentralCatheterization, PeripheralInfectionMethodsSepsisMicroscopy, Electron, ScanningSonicationTaurolidineCatheters, IndwellingPediatrics

Outcome Measures

Primary Outcomes (1)

  • Number of catheter related blood stream infections(CRBSI)in the Taurolock group vs the heparin group. Number of CRBSI/1000 CVC days in the Taurolock group vs the heparin group. Number of CVCs removed in the Taurolock group vs the heparin group

    November 2010

Secondary Outcomes (1)

  • Biofilm formation in the CVCs treated with Taurolock compared with the biofilm formation in the CVCs treated with heparin

    February 2010

Study Arms (2)

A

EXPERIMENTAL

Tunneled central venous catheters locked with Taurolock

Device: Taurolock

B

ACTIVE COMPARATOR

Tunneled central venous catheter locked with heparin

Device: Heparin

Interventions

TaurolockDEVICE

When not in use the childrens tunneled central venous catheters are locked with the liquid Taurolock instead of heparin.

A
HeparinDEVICE

When not in use the childrens tunneled central venous catheters are locked with heparin

B

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 0-17 years with malignant disease requiring a tunneled central venous catheter.

You may not qualify if:

  • No written consent from child or parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Department of Oncology A4, Aarhus Universityhospital, Skejby

Århus N, 8200, Denmark

Location

Related Publications (6)

  • Bradshaw JH, Puntis JW. Taurolidine and catheter-related bloodstream infection: a systematic review of the literature. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):179-86. doi: 10.1097/MPG.0b013e318162c428.

    PMID: 18664870BACKGROUND

  • Betjes MG, van Agteren M. Prevention of dialysis catheter-related sepsis with a citrate-taurolidine-containing lock solution. Nephrol Dial Transplant. 2004 Jun;19(6):1546-51. doi: 10.1093/ndt/gfh014. Epub 2004 Feb 19.

    PMID: 14993498BACKGROUND

  • Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.

    PMID: 17897607BACKGROUND

  • O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Infect Control Hosp Epidemiol. 2002 Dec;23(12):759-69. doi: 10.1086/502007.

    PMID: 12517020BACKGROUND

  • Raad I, Hanna HA, Alakech B, Chatzinikolaou I, Johnson MM, Tarrand J. Differential time to positivity: a useful method for diagnosing catheter-related bloodstream infections. Ann Intern Med. 2004 Jan 6;140(1):18-25. doi: 10.7326/0003-4819-140-1-200401060-00007.

    PMID: 14706968BACKGROUND

  • Handrup MM, Moller JK, Schroder H. Central venous catheters and catheter locks in children with cancer: a prospective randomized trial of taurolidine versus heparin. Pediatr Blood Cancer. 2013 Aug;60(8):1292-8. doi: 10.1002/pbc.24482. Epub 2013 Feb 15.

    PMID: 23417891DERIVED

Related Links

MeSH Terms

Conditions

BacteremiaNeoplasmsInfectionsSepsis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik Schrøder, MD, Dr.med.

    Aarhus Universityhospital, Skejby

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 14, 2008

First Posted

August 15, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

DK(1)