Perioperative anemia in patients undergoing hip and knee replacement
Conditions
Interventions
treatment group:Recombinant Human Erythropoietin Injection
control group:none
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age of 18-75 years old (inclusive of cutoff) when signing ICF; 2. Patients who met the American College of Rheumatology (ACR) criteria for osteoarthritis and underwent primary total knee or total hip arthroplasty due to end-stage osteoarthritis; 3.100 g/L= hemoglobin =140 g/L before the first dose of study treatment Study participants understand and voluntarily signed written informed consent (ICF), and the ability to follow the scheme of supervision and the relevant procedures
Exclusion criteria
Exclusion criteria: 1. Massive blood transfusion (transfusion of more than 3 units of red blood cell suspension) within 3 months before the first dose of study treatment; 2. History of deep venous thromboembolism; 3. Patients with allergy to EPO; Patients with severe uncontrolled hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =90 mmHg) before the first dose of study treatment; 4. 5. Patients who received chemoradiotherapy 3 months before the first dose of study treatment; Pregnancy and lactation women or is for pregnant women and will not be able to during the test and 6 months after the last dose of medical approved contraceptive methods of patients with fertility (both men and women);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin levels on the 7th and 14th day after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin levels on postoperative day 1, 3, 30, and 60;Incidence rate of complex complications at 30 and 60 days after operation;Blood transfusion volume and transfusion rate within 30 and 60 days after surgery;Explicit and invisible blood loss during and within 3 days after surgery;Hemoglobin levels at discharge;The proportion of patients with different degrees of anemia upon discharge;Incidence of adverse events, serious adverse events, laboratory outliers;Incidence of Adverse Events Leading to Suspension of Dosing, Permanent Discontinuation, and Early Withdrawal from the Study; | — |
Countries
China
Contacts
Public ContactPei Fuxing
West China Hospital, Sichuan University
Outcome results
None listed