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
- 1. Central vein catheter<br /> 2. hematological malignancy<br />3. urokinase.
- Registration Number
- NL-OMON26468
- Lead Sponsor
- Dept of Hematology LUMC
- Brief Summary
J Clin Oncol. 2008 Jan 20;26(3):428-33
- Detailed Description
Not available
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 (PMNs < 0.1 x 109/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;
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 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 colonization) and systemic CVC related infections.
- Secondary Outcome Measures
Name Time Method Secondary endpoints in this study were CVC-related infections caused by other microbial pathogens, premature CVC removal, secondary CVC-related complications (metastatic infection, CVC-related thrombosis), non-CVC related septicaemia bleeding and death.