Skip to main content
OpenTrials
Completed

NCT Number: NCT00207779

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

4 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre National de Greffe de Moelle Osseuse

Tunis, Tunis Governorate, 1006, Tunisia

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heparin impregnated central venous catheters

Device

Primary outcomes

  1. Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease

  2. Group A: heparin impregnated catheters

  3. Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Centre National de Greffe de Moelle Osseuse

Other Gov

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Sep 21, 2005
Registry last updated
Sep 20, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.