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Clinical Practice of Thromboprophylaxis with Treatment of Apixaban in Chinese Patients after Total Knee/ Total Hip Replacement: a Multi-Center Prospective Registry Study

Clinical Practice of Thromboprophylaxis with Treatment of Apixaban in Chinese Patients after Total Knee/ Total Hip Replacement: a Multi-Center Prospective Registry Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800014851
Enrollment
Unknown
Registered
2018-02-09
Start date
2015-09-01
Completion date
Unknown
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboprophylaxis in Chinese Patients after Total Knee/ Total Hip Replacement

Interventions

Case series:apixaban

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Public ContactXisheng Weng

Peking Union Medcial College Hospital

xshweng@medmail.com.cn+86 13366200018

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026