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

Postoperative Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05384054
• Other study ID #: 4-2022-0260
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: March 2024

Study information

• Verified date: May 2022
• Source: Yonsei University
• Contact: Young Lan Kwak
• Phone: +82-2-2228-8500
• Email: ylkwak[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Anemia

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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