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

C

Centre National de Greffe de Moelle Osseuse

Status and phase

Completed
Phase 3

Conditions

Infection

Treatments

Device: heparin impregnated central venous catheters

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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)

Full 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)

Sex

All

Ages

4 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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