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

This study has been completed.
Sponsor:
Information provided by:
Centre National de Greffe de Moelle Osseuse
ClinicalTrials.gov Identifier:
NCT00207779
First received: September 13, 2005
Last updated: September 19, 2007
Last verified: September 2007
  Purpose

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)

Condition Intervention Phase
Infection
Device: heparin impregnated central venous catheters
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Centre National de Greffe de Moelle Osseuse:

Primary Outcome Measures:
  • 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:
  • 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)

Study Start Date: May 2005
Estimated Study Completion Date: August 2005
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

Ages Eligible for Study:   4 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00207779

Locations
Tunisia
Centre National de Greffe de Moelle Osseuse
Tunis, Tunisia, 1006
Sponsors and Collaborators
Centre National de Greffe de Moelle Osseuse
Investigators
Principal Investigator: Abderrahman Abdelkefi, MD Centre National de Greffe de Moelle Osseuse
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00207779     History of Changes
Other Study ID Numbers: E02
Study First Received: September 13, 2005
Last Updated: September 19, 2007
Health Authority: Tunisia: Ministère de la Santé Publique

Keywords provided by Centre National de Greffe de Moelle Osseuse:
central venous catheter
catheter related bloodstream infection
heparin

Additional relevant MeSH terms:
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014