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


- candidate number2475
- NTR NumberNTR911
- ISRCTNISRCTN72245261
- Date ISRCTN created7-mrt-2007
- date ISRCTN requested6-mrt-2007
- Date Registered NTR19-feb-2007
- Secondary IDsN/A 
- Public TitlePrevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses. A randomised double-blind controlled trial in patients with haematological malignancies.
- Scientific TitlePrevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses. A randomised double-blind controlled trial in patients with haematological malignancies.
- ACRONYMN/A
- hypothesisUrokinase rinsed will lead to less CONS infections in patients with hematological malignancies and central vein catheters.
- Healt Condition(s) or Problem(s) studiedCentral vein catheter , Hematological malignancy, Urokinase
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-1996
- planned closingdate1-feb-1999
- Target number of participants161
- InterventionsUrokinase rinses of central vein catheter three times weekly (25,000 IU, 5 ml of 5,000 IU/ml).
- Primary outcomeThe 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 outcomeSecondary 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. PhD. M.V. Huisman
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M.V. Huisman
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Department of Hematology
- PublicationsJ Clin Oncol. 2008 Jan 20;26(3):428-33
- Brief summaryTo investigate whether three times weekly urokinase rinsing of central venous catheter (CVC) reduces the incidence or severity of CVC-related infections by coagulase-negative staphylococci (CoNS) in patients undergoing intensive cytotoxic treatment for haematological malignancies.
- Main changes (audit trail)
- RECORD19-feb-2007 - 28-aug-2008


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