Infection
Conditions
Keywords
central venous catheter, catheter related bloodstream infection, heparin
Brief summary
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
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)
Interventions
DEVICEheparin impregnated central venous catheters
Sponsors
Centre National de Greffe de Moelle Osseuse
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) | — |
Countries
Tunisia
Outcome results
None listed