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临床试验/NCT05384054
NCT05384054已完成不适用

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

Yonsei University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

Change of hemoglobin concentration level after surgery in patients undergoing heart valve surgery

时间窗: immediate 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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