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

Sponsor
Yonsei University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05384054
Collaborator
(none)
150
Enrollment
1
Location
22
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association Between Erythroferron and Perioperative Hemoglobin Levels in Patient Undergoing Heart Valve Surgery
    Anticipated Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Low Erythroferron group

    The lower concentration group will be Group1.
    High Erythroferron group

    The higher concentration group will be Group2.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05384054
    Other Study ID Numbers:
    • 4-2022-0260
    First Posted:
    May 20, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of May 20, 2022