NCT05911438

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
419

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.4 years

First QC Date

June 9, 2023

Last Update Submit

June 20, 2023

Conditions

Total Knee Arthroplasty

Keywords

Human ErythropoietinFerric Derisomaltose Injection

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin concentration

    Hemoglobin concentration

    postoperative 14±3 days

Secondary Outcomes (10)

  • Total blood loss

    postoperative 3±1 days

  • Transfusion rate and amount

    postoperative 14±3 days

  • Assess changes in serum ferritin and transferrin saturation

    postoperative 14±3 days and 28±5 days

  • Quality of life indicators (SF-12)

    postoperative 28±5 days and 90±12 days

  • The rates of adverse events (AE)

    postoperative 90±12 days

  • +5 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL
Drug: Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO)Other: Basic Treatment

Control group

PLACEBO COMPARATOR
Other: Basic Treatment

Interventions

Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO)DRUG

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.

Experimental group
Basic TreatmentOTHER

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.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Interventions

ferric derisomaltose

Central Study Contacts

Zeyu Huang, MD, PhD

CONTACT

18980602287492385233@qq.com

Fuxing Pei, MD, PhD

CONTACT

18980601380peifuxing@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Orthopaedic Surgery

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 22, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations

CN(1)