Elective primary hip replacement surgery Classification code 10020096
Conditions
Sponsors
Astellas Pharma Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Scheduled for elective primary hip replacement 2. Age 18 years or over 3. Written informed consent obtained 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: 1. Documented history or considered at increased risk of venous thromboembolism (bed-ridden for longer than 7 days prior to the operation, malignancy, tumors leading to increased risk) 2. Subjects considered at increased risk of bleeding: a. known hemorrhagic disorder b. thrombocytopenia, i.e. platelet count < 100x10E+09 g/L c. history of recent clinically important bleeding or major trauma, major surgery, or eye, spinal cord, or brain surgery d. acute bacterial endocarditis e. severe hypertension, i.e. systolic BP = 180 mmHg and/or diastolic BP = 110 mmHg f. retinopathy g. planned indwelling intrathecal or epidural catheter for more than 6 hours after the end of surgery 3. Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment 4. Concomitant use of anticoagulants/antiplatelet agents 5. Hypersensitivity to iodinated contrast media or enoxaparin 6. Myocardial infarction or stroke within the last 6 months 7. Body weight less than 50 kg 8. Abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or estimated creatinine clearance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the optimal therapeutic dose by evaluation of the efficacy of YM150 in subjects undergoing elective primary hip replacement (HR) surgery. Evaluation of the safety of YM150 in the target population.;Secondary Objective: ;Primary end point(s): Primary efficacy endpoint: - Rate of total venous thromboembolism (VTE) during hospitalization phase (up to Day 7-10) • Deep vein thrombosis (DVT) proven by bilateral venography and/or • Symptomatic DVT and/or • Pulmonary embolism Primary safety endpoint: -Incidence of clinically relevant bleedings during 7-10 days hospitalization treatment rated as Major bleeding. | — |
Countries
Austria, Czech Republic, Estonia, Finland, Germany, Greece, Italy, Latvia, Lithuania, Norway, Portugal, Sweden
Outcome results
None listed