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临床试验/NCT07113769
NCT07113769招募中不适用

Explore Plasma Biomarkers and Platelet Morphological Signatures for Predicting Prognosis in Patients With Extracorporeal CardioPulmonary Resuscitation (ECPR) Using Multi-omics and Platelet Morphology Analysis

Central China Fuwai Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
30 day mortality

研究概览

简要总结

Extracorporeal cardiopulmonary resuscitation (ECPR) constitutes a pivotal emergency intervention for cardiac arrest (CA) patients. However, current eligibility criteria and prognostic assessment metrics remain substantially limited, relying predominantly on clinical symptoms and physical signs while lacking objective biomarker data. Integrating reproducible, highly sensitive, and specific proteinaceous and metabolic indicators with ultrastructural platelet alterations may hold significant implications for both ECPR administration and prognostication in CA. Therefore, the purpose of this study is to identify the plasma proteomic and metabolomic characteristics of patients with refractory cardiac arrest before and after ECPR treatment, as well as the characteristics of platelet morphological and structural changes, to search for potential specific markers that can predict CA patients who may benefit from ECPR so as to optimize treatment selection.

研究设计

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

入排标准

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

入选标准

  • •Age between 18 and 70 years old (the age limit can be relaxed if the patient has good organ function and a good neurological prognosis after evaluation).
  • •The cardiac arrest is witnessed, and bystanders perform traditional cardiopulmonary resuscitation (CPR), and the time interval from the occurrence of cardiac arrest to the start of traditional CPR is no more than 5 minutes.
  • •The causes of cardiac arrest are reversible, such as cardiogenic, pulmonary embolism, severe hypothermia, drug poisoning, trauma, acute respiratory distress syndrome, etc.
  • •After 20 minutes of traditional CPR, there is no restoration of spontaneous circulation or hemodynamic instability, or the restoration of spontaneous circulation occurs, but the spontaneous heart rhythm cannot be maintained.
  • •The informed consent has been signed.

排除标准

  • •Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, etc.
  • •Hematological diseases, such as hematological malignancies, aplastic anemia, idiopathic thrombocytopenic purpura (ITP), etc.
  • •Malignant tumors in other systems except the hematological system.
  • •Patients who have received massive plasma or platelet transfusions during hospitalization or recently.

研究组 & 干预措施

CA patients who have fully recovered after receiving ECPR treatment

CA patients with organ dysfunction after receiving ECPR treatment

CA patients who died or suffered brain death after receiving ECPR treatment

结局指标

主要结局

30 day mortality

时间窗: Within 30 days after ECPR

Hospital survival

时间窗: Within 30 days after ECPR

次要结局

  • Cerebral Performance Category (CPC) scale(30 days after ECPR)
  • Serum Creatinine level(Within 30 days after ECPR)
  • Left Ventricular Ejection Fraction (LVEF)(Within 30 days after ECPR)
  • PaO2/FiO2 ratio(Within 30 days after ECPR)
  • Serum Bilirubin level(Within 30 days after ECPR)

研究者

发起方
Central China Fuwai Hospital of Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianchao, Li

Principal Investigator

Central China Fuwai Hospital of Zhengzhou University

研究点 (1)

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