Condition category
Infections and Infestations
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
21/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M V Huisman

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
Department of General Internal Medicine
C2-R
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 625 9111
m.v.huisman@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Urokinase rinses will lead to less Coagulase-Negative Staphylococcal (CoNS) infections in patients with haematological malignancies and central vein catheters.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, placebo controlled, parallel group, double blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Urokinase

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/01/1996

Overall trial end date

01/02/1999

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

161

Participant 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

Recruitment start date

01/01/1996

Recruitment end date

01/02/1999

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

Department of Haematology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Hospital/treatment centre

Funder name

Leiden University Medical Centre (LUMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18202420

Publication citations

  1. Results

    van Rooden CJ, Schippers EF, Guiot HF, Barge RM, Hovens MM, van der Meer FJ, Rosendaal FR, Huisman MV, Prevention of coagulase-negative staphylococcal central venous catheter-related infection using urokinase rinses: a randomized double-blind controlled trial in patients with hematologic malignancies., J. Clin. Oncol., 2008, 26, 3, 428-433, doi: 10.1200/JCO.2007.11.7754.

Additional files

Editorial Notes