Thromboprophylaxis in Chinese Patients after Total Knee/ Total Hip Replacement
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. In patients undergoing bilateral or unilateral primary elective hip or knee replacement surgery (For the bilateral knee replacement/hip replacement or knee replacement plus hip replacement, all the operations should be conducted in the same day); 2. Planned apixaban anticoagulation treatment 12 hours to 24 hours post the procedure at the discretion of orthopedic surgeon; 3. At least 18 years of age; 4. Written informed consent; 5. Availability for follow-up by either telephone visits or on site visits.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or with a positive pregnancy test on enrollment; 2. Women who are breastfeeding and are unwilling to give up breastfeeding; 3. Active pathological bleeding; 4. Presence of known bleeding disorder (e.g., Hemophilia); 5. Patients who need for ongoing treatment with anticoagulants (e.g. subject with mechanical valves) 6. Presence of active liver disease, defined as ALT or AST> 2xULN(upper limit of normal)or a Total Bilirubin/Direct Bilirubin = 1.5xULN; 7. Presence of renal dysfunction, defined as serum Creatinine or serum Urea/Urea nitrogen > 1xULN; 8. Platelet count < 100 x 10^9/L; 9. Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of the composite endpoints of major bleeding and clinically relevant non-major bleeding (CRNM);Within apixaban treatment period. Apixaban treatment period defined as within the 3 days (nearly 5 half-life of apixaban) after the last dose of apixaban; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total wound drainage volume within 3 days after surgery;Wound drainage volume at day 1 and day 2 after surgery respectively.;The distribution of major, CRNM, minor bleeding within apixaban treatment period.; | — |
Countries
China
Contacts
Peking Union Medcial College Hospital