Prevention of Catheter-Related Bloodstream Infection in P... | NCT00207779

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

NCT00207779

Sponsor

Centre National de Greffe de Moelle Osseuse

Status

Completed

Last Update Posted

Sep 20, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Infection

Interventions

heparin impregnated central venous catheters

Countries

Tunisia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Not provided

Completion Date

Aug 2005

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2007

Last Update Posted Date

Sep 20, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Centre National de Greffe de Moelle OsseuseOTHER_GOV

Collaborators

Not provided

Description Module

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
heparin impregnated central venous catheters	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abderrahman Abdelkefi, MD	Centre National de Greffe de Moelle Osseuse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre National de Greffe de Moelle Osseuse		Tunis	Tunis Governorate	1006	Tunisia

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided