Total Knee ArthroplastyHematoboostNCT05911438
Accelerated Recovery for Total Knee Replacement Surgery With Preoperative Intravenous Iron Combined With Human Erythropoietin for Rapid Hematopoietic Mobilization to Prevent Postoperative Anemia
A study testing Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO) and Basic Treatment in people with Total Knee Arthroplasty, run by West China Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO) and Basic Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 419 participants
- Where
- 1 siteChina
- Study dates
- Jul 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital, Sichuan University
Chengdu, Sichuan, 610000
Fuxing Pei, MD,PhD, 18980601380, peifuxing@vip.163.com
About this study
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
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO), Basic Treatment
- Keywords
- Human Erythropoietin, Ferric Derisomaltose Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO); Other: Basic Treatment |
| Control group | Placebo comparator | Not described Receives: Other: Basic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin concentration
Hemoglobin concentration
Measured: postoperative 14±3 days
Secondary outcomes (10)
Total blood loss
Total blood loss
Measured: postoperative 3±1 days
Transfusion rate and amount
Transfusion rate and amount
Measured: postoperative 14±3 days
Assess changes in serum ferritin and transferrin saturation
Assess changes in serum ferritin and transferrin saturation
Measured: postoperative 14±3 days and 28±5 days
Quality of life indicators (SF-12)
Quality of life indicators (SF-12)
Measured: postoperative 28±5 days and 90±12 days
The rates of adverse events (AE)
Assessed according to NCI-CTCAE v5.0 criteria
Measured: postoperative 90±12 days
The rates of serious adverse events (SAE)
Assessed according to NCI-CTCAE v5.0 criteria
Measured: postoperative 90±12 days
The rates of laboratory abnormalities
Assessed according to NCI-CTCAE v5.0 criteria
Measured: postoperative 90±12 days
The rates of adverse events leading to drug discontinuation
The rates of adverse events leading to drug discontinuation
Measured: postoperative 90±12 days
The rates of adverse events leading to permanent discontinuation
The rates of adverse events leading to permanent discontinuation
Measured: 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
Measured: postoperative 90±12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 419 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fuxing Pei, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911438
- Sponsor's protocol ID
- HX-TKA-IV-001
- Acronym
- Hematoboost
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05911438
- Acronym / sponsor ID
- Hematoboost / HX-TKA-IV-001
- Conditions
- Total Knee Arthroplasty
- Keywords
- Human Erythropoietin, Ferric Derisomaltose Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 419 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO), Other: Basic Treatment |
| Control group | Placebo comparator | Other: Basic Treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Experimental group |
| Basic TreatmentDaily 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. | Other | Control group, Experimental group |
Primary outcome
Hemoglobin concentration
Time frame: postoperative 14±3 days
Hemoglobin concentration
10 secondary outcomes
Total blood loss
Time frame: postoperative 3±1 days
Transfusion rate and amount
Time frame: postoperative 14±3 days
Assess changes in serum ferritin and transferrin saturation
Time frame: postoperative 14±3 days and 28±5 days
Quality of life indicators (SF-12)
Time frame: postoperative 28±5 days and 90±12 days
The rates of adverse events (AE)
Time frame: postoperative 90±12 days
The rates of serious adverse events (SAE)
Time frame: postoperative 90±12 days
The rates of laboratory abnormalities
Time frame: postoperative 90±12 days
The rates of adverse events leading to drug discontinuation
Time frame: postoperative 90±12 days
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
Time frame: postoperative 90±12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric Derisomaltose Injection (Monoferric) and Human Erythropoietin Injection (EPIAO) and Basic Treatment in people with Total Knee Arthroplasty, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeyu Huang, MD, PhD (18980602287, 492385233@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin concentration (time frame: postoperative 14±3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.