Prospektive, randomisierte, kontrollierte, unizentrische, offene, Studie zur Thromboembolieprophylaxe mit Enoxaparin bei nicht-chirurgischen onkologischen Patienten unter systemischer antineoplastischer Therapie - VTETumor02
- Conditions
- MedDRA version: 9.1Level: PTClassification code 10043607Term: Thrombosisto be used as prophylactic agent for thrombosis and pulmonary embolism in cancer patientsMedDRA version: 9.1Level: PTClassification code 10037377Term: Pulmonary embolism
- Registration Number
- EUCTR2007-002036-28-DE
- Lead Sponsor
- niversitätsklinikum Essen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Cancer patients
inpatients
treated with systemic antineoplastic therapy
age above 18
1-3 of the following factors given (prior thrombosis in medical history, thrombosis in family, fever, elevated CRP)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnancy (positive pregnancy test) or lactation period
Simultaneous participation in another clinical trial
Women of child-bearing age without adequate contraception
known heparin-induced thrombocytopenia (HIT) type II
life expectancy greater than 24 weeks
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Can the use of clexane reduce the incidence of thrombosis and pulmonary embolism in cancer patients;Secondary Objective: Safety of clexane;Primary end point(s): Incidence of thrombosis and/or pulmonary embolism
- Secondary Outcome Measures
Name Time Method