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ISRCTN
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ISRCTN25616445
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ClinicalTrials.gov identifier
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Public title
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Prospective, randomised, controlled open single-centre trial on thromboembolic prophylaxis with Enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy
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Scientific title
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Acronym
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VTETumor02
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Serial number at source
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N/A
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Study hypothesis
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Can the use of clexane reduce the incidence of thrombosis and pulmonary embolism in cancer patients?
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Ethics approval
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Ethics committee of the Medical Faculty of the University of Duisburg-Essen. Date of approval: 05/09/2007 (ref: 07/3375)
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Study design
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Open, randomised controlled trial.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Thrombosis and pulmonary embolism in cancer patients
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Participants - inclusion criteria
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1. Cancer patients
2. Inpatients
3. Treated with systemic antineoplastic therapy
4. Age 18-85
5. 1-3 of the following factors given:
a. Prior thrombosis in medical history
b. Thrombosis in family
c. Fever
d. Elevated C-Reactive Protein (CRP)
6. Life expectancy greater than 24 weeks
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Participants - exclusion criteria
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1. Pregnancy (positive pregnancy test) or lactating
2. Simultaneous participation in another clinical trial
3. Women of child-bearing age without adequate contraception
4. Known Heparin-Induced Thrombocytopenia (HIT) type II
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Anticipated start date
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03/12/2007
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Anticipated end date
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31/12/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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160
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Interventions
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Enoxaparin 40 mg subcutaneously daily for 24 weeks vs no therapy (because placebo injections are ethically not justifiable)
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Primary outcome measure(s)
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Incidence of thrombosis and/or pulmonary embolism. Duration of follow-up: 24 weeks
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Secondary outcome measure(s)
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1. Safety
2. Overall mortality
Duration of follow-up: 24 weeks
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Sources of funding
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Merck & Co., Inc. (USA)
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Trial website
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Publications
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Contact name
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Prof
Max E.
Scheulen
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Address
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University of Duisburg-Essen
Hufelandstr. 55
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City/town
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Essen
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Zip/Postcode
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45122
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Country
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Germany
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Sponsor
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University of Duisburg-Essen (Germany)
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Address
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c/o Professor Max E. Scheulen
Hufelandstr. 55
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City/town
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Essen
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Zip/Postcode
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45122
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Country
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Germany
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Sponsor website:
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http://www.uni-duisburg-essen.de/index.shtml.en
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Date applied
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26/11/2007
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Last edited
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04/04/2008
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Date ISRCTN assigned
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04/04/2008
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