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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00207779
First Posted: September 21, 2005
Last Update Posted: September 20, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre National de Greffe de Moelle Osseuse
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00207779     History of Changes
Other Study ID Numbers: E02
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: September 20, 2007
Last Verified: September 2007

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action