Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease

Phase 3

Completed

• Conditions: Infection

• Registration Number: NCT00207779
• Lead Sponsor: Centre National de Greffe de Moelle Osseuse

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)

Study Timeline

• Study Start: 2005-05
• Study Completion: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2007-09
• Last Update Submitted: 2007-09-19
• Last Update Posted: 2007-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Group A: heparin impregnated catheters
Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Centre National de Greffe de Moelle Osseuse; 🇹🇳 Tunis, Tunisia