ExtraCorporeal Membrane Oxygenation (ECMO)ECPRNCT07113769
Plasma Biomarkers and Platelet Morphology of Extracorporeal CardioPulmonary Resuscitation
An observational study of ExtraCorporeal Membrane Oxygenation (ECMO) and Cardiac Arrest, run by Central China Fuwai Hospital of Zhengzhou University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ExtraCorporeal Membrane Oxygenation (ECMO), Cardiac Arrest
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
About this study
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
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.
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CA patients who have fully recovered after receiving ECPR treatment | Not described | |
| CA patients with organ dysfunction after receiving ECPR treatment | Not described | |
| CA patients who died or suffered brain death after receiving ECPR treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
Measured: Within 30 days after ECPR
Hospital survival
Measured: Within 30 days after ECPR
Secondary outcomes (5)
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)
Measured: 30 days after ECPR
Left Ventricular Ejection Fraction (LVEF)
Measured: Within 30 days after ECPR
PaO2/FiO2 ratio
Measured: Within 30 days after ECPR
Serum Bilirubin level
Measured: Within 30 days after ECPR
Serum Creatinine level
Measured: Within 30 days after ECPR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtraCorporeal Membrane Oxygenation (ECMO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Central China Fuwai Hospital of Zhengzhou University
- Sponsor type
- University, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Provincial People's Hospital
- Responsible party
- Principal investigator, Jianchao, Li, Central China Fuwai Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113769
- Sponsor's protocol ID
- ljc2025 No.12
- Acronym
- ECPR
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07113769
- Acronym / sponsor ID
- ECPR / ljc2025 No.12
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Central China Fuwai Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Provincial People's Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 day mortality
Time frame: Within 30 days after ECPR
Hospital survival
Time frame: Within 30 days after ECPR
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ExtraCorporeal Membrane Oxygenation (ECMO) and Cardiac Arrest, run by Central China Fuwai Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianchao Li (+86 185 3998 9191, 381226651@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: Within 30 days after ECPR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.