NCT00207779

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 20, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2005

Last Update Submit

September 19, 2007

Conditions

Infection

Keywords

central venous cathetercatheter related bloodstream infectionheparin

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • 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)

Interventions

heparin impregnated central venous cathetersDEVICE

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 4 and 60 years
  • Short term non-tunneled percutaneous central venous catheter

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre National de Greffe de Moelle Osseuse

Tunis, Tunis Governorate, 1006, Tunisia

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Abderrahman Abdelkefi, MD

    Centre National de Greffe de Moelle Osseuse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

May 1, 2005

Study Completion

August 1, 2005

Last Updated

September 20, 2007

Record last verified: 2007-09

Locations

TU(1)