Postoperative AnemiaNCT05384054
Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery
An observational study of Postoperative Anemia, run by Yonsei University at 1 site in South Korea.
Trial summary
In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Anemia
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2022to 15 Sep 2025
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient older than 20 years and undergong elective valvular heart surgery.
Who may be able to join
- Patients older than 20 years
- undergoing elective valvular heart surgery
Who cannot join
- Emergency operation
- Co-operation with other surgeries
- Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- Patients requiring mechanical ventilator care in preoperative period
- Patient with severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
- Patients with preoperative infection status (Eg. Sepsis)
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- Patients with acute bleeding status
- Hemoglobin concentration below 10g/dL
- Disease directly affecting hematopoiesis (eg. Leukemia, myeloma, aplastic anemia)
- Uncompensated liver cirrhosis, acute hepatitis, alcoholics
- Patients who participated in other clinical studies that could affect prognosis
- Patients who cannot understand the informed consent (eg. Foreigner)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Erythroferron is the early response to of the red blood cell production in stressful situations such as anemia, bleeding, and hypoxia. Therefore, it is thought that acute blood loss and systemic inflammatory reaction that inevitably occurs after cardiac surgery will synthesize erythroferron, which helps to restore hemoglobin level at postoperative period by promoting hematopoiesis by simultaneously inhibiting hepcidin and activating hematopoiesis.
In this study, the investigators will investigate the association between Erythroferron and perioperative hemoglobin levels in patient undergoing heart valve surgery.
- Conditions
- Postoperative Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lowest Erythroferron tertile group | The lowest concentration group will be Group1. | |
| Highest Erythroferron tertile group | The highest concentration group will be Group2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery
Compare the change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery, by dividing the groups according to the level of erythroferron immediately after surgery. The amount of change will be compared based on the lowest level of hemoglobin during the time point after surgery. Since investigators planed to compare the recovery rate as well as the amount of recovery at each time point, investigators planed to record the change of hemoglobin at each time point based on the lowest hemoglobin level after surgery.
Measured: immediate after surgery, POD1, POD2, POD7, first outpatient vist after discharge (until 6 months)
Secondary outcomes (3)
Change in serum erythropoietin (EPO) level
Serum erythropoietin concentration will be measured using a quantitative ELISA assay and reported as mIU/mL. Changes in EPO level from baseline to 6 months will be compared among ERFE tertile groups.
Measured: From baseline (preoperative) to 6 months postoperatively
Change in serum hepcidin level
Serum hepcidin concentration will be measured using liquid chromatography-mass spectrometry (LC-MS) and reported as ng/mL.
Measured: From baseline (preoperative) to 6 months postoperatively
Change in hemoglobin (Hb) concentration
Hemoglobin will be measured using an automated hematology analyzer and reported as g/dL.
Measured: From baseline (preoperative) to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start23 Jun 2022
- Primary completion15 Nov 2024
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnemiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384054
- Sponsor's protocol ID
- 4-2022-0260
- Status last verified
- Sep 2025
- First submitted
- 9 May 2022
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery
- ClinicalTrials.gov ID
- NCT05384054
- Acronym / sponsor ID
- 4-2022-0260
- Conditions
- Postoperative Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 20 May 2022 (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.
In patients undergoing cardiac surgery, perioperative anemia is an important factor in surgical recovery. In addition to the low preoperative hemoglobin level, the delayed recovery of the postoperative hemoglobin level is an important problem affecting the incidence of postoperative anemia. Erythroferron is the early response to of the red blood cell production in stressful situations such as anemia, bleeding, and hypoxia. Therefore, it is thought that acute blood loss and systemic inflammatory reaction that inevitably occurs after cardiac surgery will synthesize erythroferron, which helps to restore hemoglobin level at postoperative period by promoting hematopoiesis by simultaneously inhibiting hepcidin and activating hematopoiesis.
In this study, the investigators will investigate the association between Erythroferron and perioperative hemoglobin levels in patient undergoing heart valve surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lowest Erythroferron tertile group | – | –The lowest concentration group will be Group1. |
| Highest Erythroferron tertile group | – | –The highest concentration group will be Group2. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient older than 20 years and undergong elective valvular heart surgery.
Key inclusion criteria (2 listed)
- Patients older than 20 years
- undergoing elective valvular heart surgery
Key exclusion criteria (12 listed)
- Emergency operation
- Co-operation with other surgeries
- Patients with cardiogenic shock or ventricular-assist device (eg. ECMO, IABP)
- Patients requiring mechanical ventilator care in preoperative period
- Patient with severe chronic kidney disease (GFR(CKD-EPI) <30ml/min/1.73m2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery
Time frame: immediate after surgery, POD1, POD2, POD7, first outpatient vist after discharge (until 6 months)
Compare the change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery, by dividing the groups according to the level of erythroferron immediately after surgery. The amount of change will be compared based on the lowest level of hemoglobin during the time point after surgery. Since investigators planed to compare the recovery rate as well as the amount of recovery at each time point, investigators planed to record the change of hemoglobin at each time point based on the lowest hemoglobin level after surgery.
3 secondary outcomes
Change in serum erythropoietin (EPO) level
Time frame: From baseline (preoperative) to 6 months postoperatively
Change in serum hepcidin level
Time frame: From baseline (preoperative) to 6 months postoperatively
Change in hemoglobin (Hb) concentration
Time frame: From baseline (preoperative) to 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Anemia, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 2 Oct 2025. 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery (time frame: immediate after surgery, POD1, POD2, POD7, first outpatient vist after discharge (until 6 months)). 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 2 Oct 2025.