- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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)
Study Overview
Status
Conditions
Intervention / Treatment
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)
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Tunis, Tunisia, 1006
- Centre National de Greffe de Moelle Osseuse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
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Group A: heparin impregnated catheters
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Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
|
Secondary Outcome Measures
Outcome Measure |
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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)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Abderrahman Abdelkefi, MD, Centre National de Greffe de Moelle Osseuse
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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