Clinical trial NCT00207779: Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Keywords: central venous catheter
catheter related bloodstream infection
heparin
Lead sponsor: Centre National de Greffe de Moelle Osseuse
Sponsor class: OTHER_GOV
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease.

The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:

* Group A: heparin impregnated catheters
* Group B: low-dose unfractionated heparin (100 IU/kg/daily)

Detailed description: Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. Seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. Although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections.

We have shown in a randomised study (in press), that low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:

* Group A: heparin impregnated catheters
* Group B: low-dose unfractionated heparin (100 IU/kg/daily)

Eligibility criteria: Inclusion Criteria:

* Age between 4 and 60 years
* Short term non-tunneled percutaneous central venous catheter

Exclusion Criteria:

* Presence of a central venous catheter at admission
* Major blood coagulation disorders (platelet count \< 50 x 10\^9, disseminated intravascular coagulation)
* Absence of catheter-tip culture at the time of catheter removal

Primary outcomes:
measure: Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
measure: Group A: heparin impregnated catheters
measure: Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
Secondary outcomes:
measure: Analysis of variables that may be significant for the development of catheter-related bloodstream infection (catheter-related thrombosis; age; underlying disease; side of venous puncture; duration of catheterization)
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Centre National de Greffe de Moelle Osseuse
Study officials:
affiliation: Centre National de Greffe de Moelle Osseuse
name: Abderrahman Abdelkefi, MD
role: PRINCIPAL_INVESTIGATOR
References: