Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Prospective, randomised, controlled open single-centre trial on thromboembolic prophylaxis with Enoxaparin in non-surgical cancer patients under systemic antineoplastic therapy
Acronym
VTETumor02
Study hypothesis
Can 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
Ethics committee of the Medical Faculty of the University of Duisburg-Essen gave approval on the 5th September 2007 (ref: 07/3375)
Study design
Open randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Thrombosis and pulmonary embolism in cancer patients
Intervention
Enoxaparin 40 mg subcutaneously daily for 24 weeks versus no therapy (because placebo injections are ethically not justifiable).
Intervention type
Drug
Phase
Not Applicable
Drug names
Clexane® (Enoxaparin)
Primary outcome measures
Incidence of thrombosis and/or pulmonary embolism. Duration of follow-up: 24 weeks
Secondary outcome measures
1. Safety
2. Overall mortality
Duration of follow-up: 24 weeks
Overall trial start date
03/12/2007
Overall trial end date
31/12/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant exclusion criteria
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
Recruitment start date
03/12/2007
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Germany
Trial participating centre
University of Duisburg-Essen
Essen
45122
Germany
Sponsor information
Organisation
University of Duisburg-Essen (Germany)
Sponsor details
c/o Professor Max E. Scheulen
Hufelandstr. 55
Essen
45122
Germany
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Merck & Co., Inc. (USA)
Alternative name(s)
Merck & Co., Inc.
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
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