Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation

NCT ID: NCT07113769

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-11-30

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

ExtraCorporeal Membrane Oxygenation (ECMO); Cardiac Arrest

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

CA patients who have fully recovered after receiving ECPR treatment

No interventions assigned to this group

CA patients with organ dysfunction after receiving ECPR treatment

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 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).

2. 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.

3. The causes of cardiac arrest are reversible, such as cardiogenic, pulmonary embolism, severe hypothermia, drug poisoning, trauma, acute respiratory distress syndrome, etc.

4. 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.

5. The informed consent has been signed.

Exclusion Criteria

1. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, etc.

2. Hematological diseases, such as hematological malignancies, aplastic anemia, idiopathic thrombocytopenic purpura (ITP), etc.

3. Malignant tumors in other systems except the hematological system.

4. Patients who have received massive plasma or platelet transfusions during hospitalization or recently.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Central China Fuwai Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Jianchao, Li

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

ljc2025 No.12

Identifier Type: -

Identifier Source: org_study_id