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

NCT ID: NCT00207779

Last Updated: 2007-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-08-31

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

Keywords

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central venous catheter catheter related bloodstream infection heparin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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heparin impregnated central venous catheters

Intervention Type DEVICE

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre National de Greffe de Moelle Osseuse

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Abderrahman Abdelkefi, MD

Role: PRINCIPAL_INVESTIGATOR

Centre National de Greffe de Moelle Osseuse

Locations

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Centre National de Greffe de Moelle Osseuse

Tunis, Tunis Governorate, Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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E02

Identifier Type: -

Identifier Source: org_study_id