Prevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses: a randomised double-blind controlled trial in patients with haematological malignancies

Completed

• Conditions: Coagulase-negative staphylococcal central venous catheter-related infection; Infections and Infestations; Central venous catheter-related infections

• Registration Number: ISRCTN72245261
• Lead Sponsor: eiden University Medical Centre (LUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-07
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 161

Inclusion Criteria

1. Age of 18 years or older
2. Admission to undergo intensive cytotoxic treatment associated with disruption of the mucosa and deep granulocytopenia (Polymorphonuclear cells [PMNs] less than 0.1 x 10^9/L) for at least 14 days

Exclusion Criteria

1. Patients with pre-existing bleeding disorders
2. Patients treated with intravenous unfractionated heparin to prevent veno-occlusive disease
3. Patients with documented septicaemia prior to the start of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main endpoints of the study were the occurrence of any Central Venous Catheter (CVC)-related infection by CoNS. According to previously described criteria these infections were classified as local CVC related infection (insertion site infection or significant CVC colonisation) and systemic CVC­related infections.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints in this study were:<br>1. CVC-related infections caused by other microbial pathogens<br>2. Premature CVC removal<br>3. Secondary CVC-related complications (metastatic infection, CVC-related thrombosis)<br>4. Non-CVC related septicaemia bleeding<br>5. Death