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

NCT05384054 | Completed

• 1 other identifier: 4-2022-0260
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Anemia

Outcome Measures

Primary Outcomes (1)

• 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.

  immediate after surgery, POD1, POD2, POD7, first outpatient vist after discharge (until 6 months)

Secondary Outcomes (3)

• Change in serum erythropoietin (EPO) level

  From baseline (preoperative) to 6 months postoperatively

• Change in serum hepcidin level

  From baseline (preoperative) to 6 months postoperatively

• Change in hemoglobin (Hb) concentration

  From baseline (preoperative) to 6 months postoperatively

Study Arms (2)

Lowest Erythroferron tertile group

The lowest concentration group will be Group1.

Highest Erythroferron tertile group

The highest concentration group will be Group2.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient older than 20 years and undergong elective valvular heart surgery.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for Erythroferrone/Hepcidin/FGF-23 measurement

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 20, 2022
• Study Start: June 23, 2022
• Primary Completion: November 15, 2024
• Study Completion: September 15, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)