Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia
NCT05911438 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 419
Last updated 2023-06-22
Summary
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.
Conditions
- Total Knee Arthroplasty
Interventions
- DRUG
-
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO)
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.
- OTHER
-
Basic Treatment
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.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-31
- Primary Completion
- 2024-12-31
- Completion
- 2025-06-30
Countries
- China
Study Locations
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