Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral China Fuwai Hospital of Zhengzhou University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
130 Participants
are grouped into 3 trial groupsGroup A: CA patients who have fully recovered after receiving ECPR treatment
Group B: CA patients with organ dysfunction after receiving ECPR treatment
Group C: CA patients who died or suffered brain death after receiving ECPR treatment
Trial outcomes
Primary outcomes
1
30 day mortality
Time frame
Within 30 days after ECPR2
Hospital survival
Time frame
Within 30 days after ECPRSecondary outcomes
1
Cerebral Performance Category (CPC) scale
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)
Time frame
30 days after ECPR2
Left Ventricular Ejection Fraction (LVEF)
Time frame
Within 30 days after ECPR3
PaO2/FiO2 ratio
Time frame
Within 30 days after ECPR4
Serum Bilirubin level
Time frame
Within 30 days after ECPRSponsors and contacts
Click on the lead sponsor to view all of their trials.
Central China Fuwai Hospital of Zhengzhou University
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Henan Provincial People's Hospital
Collaborator
Source ClinicalTrials.gov