This study is a randomized, placebo-controlled, multicenter research design to investigate the effectiveness and safety of a single-dose intravenous iron combined with HuEPO hematopoietic mobilization before surgery in patients undergoing unilateral total knee arthroplasty for the first time.
This study is a randomized, placebo-controlled, multicenter research design to investigate the effectiveness and safety of a single-dose intravenous iron combined with HuEPO hematopoietic mobilization before surgery in patients undergoing unilateral total knee arthroplasty for the first time. The study consists of a pilot trial and a formal trial. The pilot trial plans to enroll 20 subjects, with 10 subjects randomly assigned to the experimental group and 10 subjects to the control group. After the successful completion of the pilot trial, its safety and effectiveness, as determined by the investigators, hematologists, orthopedic surgeons, and statisticians, and the formal trial will be initiated. The relevant information and results will also be submitted to the ethics review committee. The formal trial plans to enroll 399 eligible subjects, with a random allocation ratio of 2:1 to the experimental group or the control group. To ensure the safety of the subjects, the last subject in the pilot trial will be followed up for 21 days after surgery. The safety and effectiveness of the pilot trial results will be discussed by the investigators, hematologists, orthopedic surgeons, and statisticians before initiating the formal trial. The timing of medication, sample size, and visit points in the formal trial may be adjusted appropriately based on the results of the pilot trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
419
Ferric Derisomaltose Injection (Monoferric): 1000 mg, intravenous infusion 6±2 days before surgery; Human Erythropoietin Injection (EPIAO): 36000 IU, subcutaneous injection 6±2 days before surgery and 3±1 days after surgery.
Daily energy intake of 20-30 kcal/kg, with fat accounting for 20-30% of total energy; Iron: ≥15 mg/d, protein intake of 1.2-1.5 g/kg/d; Simultaneously enhance functional exercises.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Hemoglobin concentration
Hemoglobin concentration
Time frame: postoperative 14±3 days
Total blood loss
Total blood loss
Time frame: postoperative 3±1 days
Transfusion rate and amount
Transfusion rate and amount
Time frame: postoperative 14±3 days
Assess changes in serum ferritin and transferrin saturation
Assess changes in serum ferritin and transferrin saturation
Time frame: postoperative 14±3 days and 28±5 days
Quality of life indicators (SF-12)
Quality of life indicators (SF-12)
Time frame: postoperative 28±5 days and 90±12 days
The rates of adverse events (AE)
Assessed according to NCI-CTCAE v5.0 criteria
Time frame: postoperative 90±12 days
The rates of serious adverse events (SAE)
Assessed according to NCI-CTCAE v5.0 criteria
Time frame: postoperative 90±12 days
The rates of laboratory abnormalities
Assessed according to NCI-CTCAE v5.0 criteria
Time frame: postoperative 90±12 days
The rates of adverse events leading to drug discontinuation
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The rates of adverse events leading to drug discontinuation
Time frame: postoperative 90±12 days
The rates of adverse events leading to permanent discontinuation
The rates of adverse events leading to permanent discontinuation
Time frame: postoperative 90±12 days
The rates of adverse events leading to early withdrawal from the study
The rates of adverse events leading to early withdrawal from the study
Time frame: postoperative 90±12 days