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

NCT00413738 | Completed Phase 3

• 1 other identifier: Catheters04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with hemato-oncological disease: Group A: heparin-coated central venous catheters (Control Group) Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters

Conditions

Infection

Keywords

Central venous catheter; Catheter related bloodstream infection; Heparin; Chlorhexidine; Sulfadiazine

Outcome Measures

Primary Outcomes (3)

• The primary outcome of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with hemato-oncological disease:

• Group A: heparin-coated central venous catheters (Control Group)

• Group B: antiseptic-coated (chlorhexidine-silver sulfadiazine) central venous catheters

Secondary Outcomes (1)

• Analysis of variables that may be significant for the development of CRBI (age, gender, underlying disease...)

Interventions

Antiseptic-coated central venous catheters DEVICE

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible for the study if they are between 4 and 65 years of age and have a short-term non-tunneled percutaneous CVL.

You may not qualify if:

• The presence of a CVL at admission
• An anticipated duration of catheterization of less than 5 days or more than 35 days
• A contraindication to the use of subclavian catheterization due to major blood coagulation disorders (ie, platelet count \< 50 x 10\^9/L)
• Disseminated intravascular coagulation
• Prior allergic reactions to heparin or to CSS
• An aberrant course of the CVL (jugular vein)
• An absence of catheter-tip culture at the time of catheter removal.

Sponsors & Collaborators

• Centre National de Greffe de Moelle Osseuse: lead

Related Publications (4)

• Abdelkefi A, Achour W, Ben Othman T, Torjman L, Ladeb S, Lakhal A, Hsairi M, Kammoun L, Ben Hassen A, Ben Abdeladhim A. Difference in time to positivity is useful for the diagnosis of catheter-related bloodstream infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2005 Feb;35(4):397-401. doi: 10.1038/sj.bmt.1704773.

  PMID: 15640824 BACKGROUND

• Abdelkefi A, Torjman L, Ladeb S, Othman TB, Achour W, Lakhal A, Hsairi M, Kammoun L, Hassen AB, Abdeladhim AB. Randomized trial of prevention of catheter-related bloodstream infection by continuous infusion of low-dose unfractionated heparin in patients with hematologic and oncologic disease. J Clin Oncol. 2005 Nov 1;23(31):7864-70. doi: 10.1200/JCO.2004.00.9787.

  PMID: 16258088 BACKGROUND

• Abdelkefi A, Ben Romdhane N, Kriaa A, Chelli M, Torjman L, Ladeb S, Ben Othman T, Lakhal A, Guermazi S, Ben Hassen A, Ladeb F, Ben Abdeladhim A. Prevalence of inherited prothrombotic abnormalities and central venous catheter-related thrombosis in haematopoietic stem cell transplants recipients. Bone Marrow Transplant. 2005 Nov;36(10):885-9. doi: 10.1038/sj.bmt.1705156.

  PMID: 16151418 BACKGROUND

• Abdelkefi A, Ben Othman T, Kammoun L, Chelli M, Romdhane NB, Kriaa A, Ladeb S, Torjman L, Lakhal A, Achour W, Ben Hassen A, Hsairi M, Ladeb F, Ben Abdeladhim A. Prevention of central venous line-related thrombosis by continuous infusion of low-dose unfractionated heparin, in patients with haemato-oncological disease. A randomized controlled trial. Thromb Haemost. 2004 Sep;92(3):654-61. doi: 10.1160/TH04-02-0087.

  PMID: 15351864 BACKGROUND

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: December 19, 2006
• First Posted: December 20, 2006
• Study Start: December 1, 2006
• Study Completion: January 1, 2009
• Last Updated: January 27, 2009

Record last verified: 2009-01