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Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery

Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05384054
Enrollment
150
Registered
2022-05-20
Start date
2022-06-23
Completion date
2025-09-15
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Anemia

Brief 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. 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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients older than 20 years * undergoing elective valvular heart surgery

Exclusion criteria

* 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) * 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)

Design outcomes

Primary

MeasureTime frameDescription
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgeryimmediate 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.

Secondary

MeasureTime frameDescription
Change in serum erythropoietin (EPO) levelFrom baseline (preoperative) to 6 months postoperativelySerum 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.
Change in serum hepcidin levelFrom baseline (preoperative) to 6 months postoperativelySerum hepcidin concentration will be measured using liquid chromatography-mass spectrometry (LC-MS) and reported as ng/mL.
Change in hemoglobin (Hb) concentrationFrom baseline (preoperative) to 6 months postoperativelyHemoglobin will be measured using an automated hematology analyzer and reported as g/dL.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026