to be used as prophylactic agent for thrombosis and pulmonary embolism in cancer patients MedDRA version: 9.1 Level: PT Classification code 10043607 Term: Thrombosis MedDRA version: 9.1 Level: PT Classification code 10037377 Term: Pulmonary embolism
Conditions
Interventions
Trade Name: Clexane 40 mg Duo
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Enoxaparin-Natrium
CAS Number: 9041-08-1
Concentration unit: mg milligram(s)
Concentration type: equal
Co
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Outcome results
None listed