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NCT Number: NCT07113769

Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30 day mortality

    Time frame: Within 30 days after ECPR

  2. Hospital survival

    Time frame: Within 30 days after ECPR

Secondary outcomes

  1. Cerebral Performance Category (CPC) scale

    Time frame: 30 days after ECPR

    Cerebral Performance Category scale Range: 1 to 5 Interpretation: Lower scores indicate better neurological outcome (1 = good cerebral performance, 5 = brain death or severe vegetative state)

  2. Left Ventricular Ejection Fraction (LVEF)

    Time frame: Within 30 days after ECPR

  3. PaO2/FiO2 ratio

    Time frame: Within 30 days after ECPR

  4. Serum Bilirubin level

    Time frame: Within 30 days after ECPR

  5. Serum Creatinine level

    Time frame: Within 30 days after ECPR

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Central China Fuwai Hospital of Zhengzhou University

Other

Collaborators

  • Henan Provincial People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Registry information

Official study 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

Acronym: ECPR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 11, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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