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

Primary Purpose

Infection

Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
heparin impregnated central venous catheters
Sponsored by
Centre National de Greffe de Moelle Osseuse
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infection focused on measuring central venous catheter, catheter related bloodstream infection, heparin

Eligibility Criteria

4 Years - 60 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre National de Greffe de Moelle Osseuse

Outcomes

Primary Outcome Measures

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

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)

Full Information

First Posted
September 13, 2005
Last Updated
September 19, 2007
Sponsor
Centre National de Greffe de Moelle Osseuse
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1. Study Identification

Unique Protocol Identification Number
NCT00207779
Brief Title
Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre National de Greffe de Moelle Osseuse

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
central venous catheter, catheter related bloodstream infection, heparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
heparin impregnated central venous catheters
Primary Outcome Measure Information:
Title
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Title
Group A: heparin impregnated catheters
Title
Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abderrahman Abdelkefi, MD
Organizational Affiliation
Centre National de Greffe de Moelle Osseuse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre National de Greffe de Moelle Osseuse
City
Tunis
ZIP/Postal Code
1006
Country
Tunisia

12. IPD Sharing Statement

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

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