Thromboembolic prophylaxis with enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy

ISRCTN ISRCTN25616445
DOI https://doi.org/10.1186/ISRCTN25616445
Secondary identifying numbers N/A
Submission date
26/11/2007
Registration date
04/04/2008
Last edited
03/08/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Max E. Scheulen
Scientific

University of Duisburg-Essen
Hufelandstr. 55
Essen
45122
Germany

Study information

Study designOpen randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleProspective, randomised, controlled open single-centre trial on thromboembolic prophylaxis with Enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy
Study acronymVTETumor02
Study objectivesCan the use of Clexane® reduce the incidence of thrombosis and pulmonary embolism in cancer patients?

As of 20/02/2009 this record was updated to include an extended end date; the initial end date at the time of registration was 31/12/2008.
Ethics approval(s)Ethics committee of the Medical Faculty of the University of Duisburg-Essen gave approval on the 5th September 2007 (ref: 07/3375)
Health condition(s) or problem(s) studiedThrombosis and pulmonary embolism in cancer patients
InterventionEnoxaparin 40 mg subcutaneously daily for 24 weeks versus no therapy (because placebo injections are ethically not justifiable).
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Clexane® (Enoxaparin)
Primary outcome measureIncidence of thrombosis and/or pulmonary embolism. Duration of follow-up: 24 weeks
Secondary outcome measures1. Safety
2. Overall mortality

Duration of follow-up: 24 weeks
Overall study start date03/12/2007
Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Key inclusion criteria1. Cancer patients
2. Inpatients
3. Treated with systemic antineoplastic therapy
4. Aged 18 - 85 years, either sex
5. One to three of the following factors given:
5.1. Prior thrombosis in medical history
5.2. Thrombosis in family
5.3. Fever
5.4. Elevated C-reactive protein (CRP)
6. Life expectancy greater than 24 weeks
Key exclusion criteria1. 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
Date of first enrolment03/12/2007
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

University of Duisburg-Essen
Essen
45122
Germany

Sponsor information

University of Duisburg-Essen (Germany)
University/education

c/o Professor Max E. Scheulen
Hufelandstr. 55
Essen
45122
Germany

http://www.uni-duisburg-essen.de/index.shtml.en
ROR logo https://ror.org/04mz5ra38

Funders

Funder type

Industry

Merck & Co., Inc. (USA)
Government organisation / For-profit companies (industry)
Alternative name(s)
Merck & Co., Inc., Merck & Co.
Location
United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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