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

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

Conditions
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Infection

Intervention / Treatment
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* Device: heparin impregnated central venous catheters


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: heparin impregnated central venous catheters|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheter, catheter related bloodstream infection, heparin