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

Primary Purpose

Total Knee Arthroplasty

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO)
Basic Treatment
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Knee Arthroplasty focused on measuring Human Erythropoietin, Ferric Derisomaltose Injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China Hospital, Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin concentration
Hemoglobin concentration

Secondary Outcome Measures

Total blood loss
Total blood loss
Transfusion rate and amount
Transfusion rate and amount
Assess changes in serum ferritin and transferrin saturation
Assess changes in serum ferritin and transferrin saturation
Quality of life indicators (SF-12)
Quality of life indicators (SF-12)
The rates of adverse events (AE)
Assessed according to NCI-CTCAE v5.0 criteria
The rates of serious adverse events (SAE)
Assessed according to NCI-CTCAE v5.0 criteria
The rates of laboratory abnormalities
Assessed according to NCI-CTCAE v5.0 criteria
The rates of adverse events leading to drug discontinuation
The rates of adverse events leading to drug discontinuation
The rates of adverse events leading to permanent discontinuation
The rates of adverse events leading to permanent discontinuation
The rates of adverse events leading to early withdrawal from the study
The rates of adverse events leading to early withdrawal from the study

Full Information

First Posted
June 9, 2023
Last Updated
June 20, 2023
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05911438
Brief Title
Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Arthroplasty
Keywords
Human Erythropoietin, Ferric Derisomaltose Injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
419 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Basic Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin concentration
Description
Hemoglobin concentration
Time Frame
postoperative 14±3 days
Secondary Outcome Measure Information:
Title
Total blood loss
Description
Total blood loss
Time Frame
postoperative 3±1 days
Title
Transfusion rate and amount
Description
Transfusion rate and amount
Time Frame
postoperative 14±3 days
Title
Assess changes in serum ferritin and transferrin saturation
Description
Assess changes in serum ferritin and transferrin saturation
Time Frame
postoperative 14±3 days and 28±5 days
Title
Quality of life indicators (SF-12)
Description
Quality of life indicators (SF-12)
Time Frame
postoperative 28±5 days and 90±12 days
Title
The rates of adverse events (AE)
Description
Assessed according to NCI-CTCAE v5.0 criteria
Time Frame
postoperative 90±12 days
Title
The rates of serious adverse events (SAE)
Description
Assessed according to NCI-CTCAE v5.0 criteria
Time Frame
postoperative 90±12 days
Title
The rates of laboratory abnormalities
Description
Assessed according to NCI-CTCAE v5.0 criteria
Time Frame
postoperative 90±12 days
Title
The rates of adverse events leading to drug discontinuation
Description
The rates of adverse events leading to drug discontinuation
Time Frame
postoperative 90±12 days
Title
The rates of adverse events leading to permanent discontinuation
Description
The rates of adverse events leading to permanent discontinuation
Time Frame
postoperative 90±12 days
Title
The rates of adverse events leading to early withdrawal from the study
Description
The rates of adverse events leading to early withdrawal from the study
Time Frame
postoperative 90±12 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeyu Huang, MD, PhD
Phone
18980602287
Email
492385233@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuxing Pei, MD, PhD
Phone
18980601380
Email
peifuxing@vip.163.com
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuxing Pei, MD,PhD
Phone
18980601380
Email
peifuxing@vip.163.com

12. IPD Sharing Statement

Learn more about this trial

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

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