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

Sponsored by:	Centre National de Greffe de Moelle Osseuse
Information provided by:	Centre National de Greffe de Moelle Osseuse
ClinicalTrials.gov Identifier:	NCT00207779

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 III

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Study ID Numbers:	E02
Study First Received:	September 13, 2005
Last Updated:	September 19, 2007
ClinicalTrials.gov Identifier:	NCT00207779
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

Study placed in the following topic categories:

Heparin
Calcium heparin

Additional relevant MeSH terms:

Communicable Diseases
Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009