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Recruiting NCT07113769

Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation

— Observational ExtraCorporeal Membrane Oxygenation (ECMO) Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ExtraCorporeal Membrane Oxygenation (ECMO), Cardiac Arrest. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Primary outcome measures

  • 30 day mortality [Time frame: Within 30 days after ECPR]
  • Hospital survival [Time frame: Within 30 days after ECPR]
Secondary outcome measures (5)
  • Cerebral Performance Category (CPC) scale [Time frame: 30 days after ECPR]
  • Left Ventricular Ejection Fraction (LVEF) [Time frame: Within 30 days after ECPR]
  • PaO2/FiO2 ratio [Time frame: Within 30 days after ECPR]
  • Serum Bilirubin level [Time frame: Within 30 days after ECPR]
  • Serum Creatinine level [Time frame: Within 30 days after ECPR]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Fuwai Central China Cardiovascular Hospital — Zhengzhou

Identifiers

NCT: NCT07113769 · ljc2025 No.12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗