Condition category
Circulatory System
Date applied
26/11/2007
Date assigned
04/04/2008
Last edited
03/08/2009
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

Prof Max E. Scheulen

ORCID ID

Contact details

University of Duisburg-Essen
Hufelandstr. 55
Essen
45122
Germany

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

http://www.uni-duisburg-essen.de/index.shtml.en

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

Publication citations

Additional files

Editorial Notes