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

ISRCTN	ISRCTN72245261
DOI	https://doi.org/10.1186/ISRCTN72245261
Protocol serial number	N/A
Sponsor	Leiden University Medical Centre (LUMC) (The Netherlands)
Funder	Leiden University Medical Centre (LUMC) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr M V Huisman
Scientific

Leiden University Medical Centre (LUMC)
Department of General Internal Medicine, C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 625 9111
Email	m.v.huisman@lumc.nl

Primary study design	Interventional
Study design	Randomised, placebo controlled, parallel group, double blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Urokinase rinses will lead to less Coagulase-Negative Staphylococcal (CoNS) infections in patients with haematological malignancies and central vein catheters.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Coagulase-negative staphylococcal central venous catheter-related infection
Intervention	Urokinase rinses of central vein catheter three times weekly (25,000 IU, 5 ml of 5,000 IU/ml).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Urokinase
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Secondary endpoints in this study were: 1. CVC-related infections caused by other microbial pathogens 2. Premature CVC removal 3. Secondary CVC-related complications (metastatic infection, CVC-related thrombosis) 4. Non-CVC related septicaemia bleeding 5. Death
Completion date	01/02/1999

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	161
Key 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
Key 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
Date of first enrolment	01/01/1996
Date of final enrolment	01/02/1999

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	20/01/2008		Yes	No