Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia

Total Knee Arthroplasty Clinical Trial

— Hematoboost  

Official title:

Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia: a Multicenter Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05911438
• Other study ID #: HX-TKA-IV-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: June 2025

Study information

• Verified date: June 2023
• Source: West China Hospital
• Contact: Zeyu Huang, MD, PhD
• Phone: 18980602287
• Email: 492385233[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 419
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 75 years (inclusive) and no gender restriction at the time of signing the informed consent form (ICF).

• Patients who meet the diagnostic criteria for osteoarthritis according to the American College of Rheumatology (ACR) and are undergoing primary total knee arthroplasty due to end-stage osteoarthritis. Flexion deformity <30°, varus deformity <30°, valgus deformity <20°.

• Baseline hemoglobin level: 100g/L < Hb < 130g/L.

• No deep venous thrombosis observed on preoperative bilateral lower limb venous color Doppler ultrasound.

• The subject understands and voluntarily signs the written informed consent form (ICF) and is capable of complying with the scheduled visits and related procedures as outlined in the protocol.

Exclusion Criteria:

• Known allergy to any excipients in the investigational drugs iron sucrose and erythropoietin or a history of multiple allergies.

• Mean corpuscular volume (MCV) > 100 fL.

• Numeric Rating Scale (NRS) score = 3.

• Presence of iron overload (serum ferritin > 800 ng/ml) or iron utilization disorders (such as hemochromatosis and iron deposition disorders).

• Blood disorders other than iron-deficiency anemia.

• Blood transfusion within the past 30 days.

• Use of iron preparations or HuEPO for the treatment of anemia within the past 30 days.

• History of deep vein thrombosis or pulmonary embolism.

• Patients with hypophosphatemia due to various causes.

• BMI < 18.5 kg/m2 or body weight < 50 kg.

• History of recent myocardial infarction, angina pectoris, cerebral infarction, or epileptic seizures within the past 6 months.

• Use of medications affecting coagulation and antiplatelet function within the past week.

• Moderate liver impairment: Decompensated liver cirrhosis or hepatitis, ALT, AST > 3 times the upper limit of normal (ULN).

• Moderate renal impairment: Serum creatinine (Cr) > 150 µmol/L.

• HIV or syphilis patients.

• Pregnant or lactating women.

• Participants who have previously participated in other clinical trials, provided the previous investigational drug exposure did not exceed 5 half-lives.

• Acute infection, rheumatoid arthritis, or significant joint inflammation.

• Patients deemed unsuitable to participate in this clinical trial by the investigator.

Related Conditions & MeSH terms

• Anemia
• Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin concentration	Hemoglobin concentration	postoperative 14±3 days
Secondary	Total blood loss	Total blood loss	postoperative 3±1 days
Secondary	Transfusion rate and amount	Transfusion rate and amount	postoperative 14±3 days
Secondary	Assess changes in serum ferritin and transferrin saturation	Assess changes in serum ferritin and transferrin saturation	postoperative 14±3 days and 28±5 days
Secondary	Quality of life indicators (SF-12)	Quality of life indicators (SF-12)	postoperative 28±5 days and 90±12 days
Secondary	The rates of adverse events (AE)	Assessed according to NCI-CTCAE v5.0 criteria	postoperative 90±12 days
Secondary	The rates of serious adverse events (SAE)	Assessed according to NCI-CTCAE v5.0 criteria	postoperative 90±12 days
Secondary	The rates of laboratory abnormalities	Assessed according to NCI-CTCAE v5.0 criteria	postoperative 90±12 days
Secondary	The rates of adverse events leading to drug discontinuation	The rates of adverse events leading to drug discontinuation	postoperative 90±12 days
Secondary	The rates of adverse events leading to permanent discontinuation	The rates of adverse events leading to permanent discontinuation	postoperative 90±12 days
Secondary	The rates of adverse events leading to early withdrawal from the study	The rates of adverse events leading to early withdrawal from the study	postoperative 90±12 days