Viewing Study NCT00207779



Ignite Creation Date: 2024-05-05 @ 11:59 AM
Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00207779
Status: COMPLETED
Last Update Posted: 2007-09-20
First Post: 2005-09-13

Brief Title: Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
Sponsor: Centre National de Greffe de Moelle Osseuse
Organization: Centre National de Greffe de Moelle Osseuse

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2007-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 IUkgdaily 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 IUkgdaily
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 IUkgdaily 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 IUkgdaily

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None