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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.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26468
Enrollment
161
Registered
2007-02-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Central vein catheter

Interventions

Urokinase rinses of central vein catheter three times weekly (25,000 IU, 5 ml of 5,000 IU/ml).

Sponsors

Dept of Hematology LUMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactM.V. Huisman

Leiden University Medical Center (LUMC) Department of Thrombosis and Haemostasis Room C4-68 P.O Box 9600

m.v.huisman@lumc.nl+31 (0)71 5262085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)