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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014