Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation

NCT07113769 | Recruiting

• 1 other identifier: ljc2025 No.12
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest; ExtraCorporeal Membrane Oxygenation (ECMO)

Outcome Measures

Primary Outcomes (2)

• 30 day mortality

  Within 30 days after ECPR

• Hospital survival

  Within 30 days after ECPR

Secondary Outcomes (5)

• Cerebral Performance Category (CPC) scale

  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

• Serum Creatinine level

  Within 30 days after ECPR

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult patients receiving ECPR will be included. The decision to perform an ECPR is made by the local protocol and clinical judgment of the attending physician.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Henan Provincial People's Hospital: collaborator
• Central China Fuwai Hospital of Zhengzhou University: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma 、platelet

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jianchao Li

CONTACT

+86 185 3998 9191; 381226651@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (1)