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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR911 |
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Date of registration:
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19/02/2007 |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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. - N/A |
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Date of first enrolment:
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1/1/1996 |
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Target sample size:
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161 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=911 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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M.V.
Huisman |
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Address:
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Leiden University Medical Center (LUMC)
Department of Thrombosis and Haemostasis
Room C4-68
P.O Box 9600
, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5262085 |
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Email:
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m.v.huisman@lumc.nl |
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Affiliation:
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Name:
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M.V.
Huisman |
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Address:
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Leiden University Medical Center (LUMC)
Department of Thrombosis and Haemostasis
Room C4-68
P.O Box 9600
, Albinusdreef 2
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5262085 |
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Email:
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m.v.huisman@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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;
3. Patients with documented septicaemia prior to the start of the study.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Central vein catheter , Hematological malignancy, Urokinase
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Intervention(s)
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Urokinase rinses of central vein catheter three times weekly (25,000 IU, 5 ml of 5,000 IU/ml).
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN72245261
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N/A
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Source(s) of Monetary Support
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Leiden University Medical Center (LUMC), Department of Hematology
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