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

• Conditions: Postoperative Anemia

• Registration Number: NCT05384054
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-17
• Last Update Submitted: 2022-05-17
• Study First Posted: 2022-05-20
• Last Update Posted: 2022-05-20
• Primary Completion: 2024-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery	at immediate after surgery, 1 day after surgery, 2 days after surgery(POD2), 7 days after surgery (POD7), first outpatient visit (up to 1 month after surgery) after discharge	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.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of