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

Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00207779
• Other study ID #: E02
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 19, 2007
• Start date: May 2005
• Est. completion date: August 2005

Study information

• Verified date: September 2007
• Source: Centre National de Greffe de Moelle Osseuse
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Ministère de la Santé Publique
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Device:
• heparin impregnated central venous catheters

Locations

Country	Name	City	State
Tunisia	Centre National de Greffe de Moelle Osseuse	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Centre National de Greffe de Moelle Osseuse

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Primary	Group A: heparin impregnated catheters
Primary	Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
Secondary	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)