Extracorporeal Membrane Oxygenation ComplicationECPR-ChinaNCT04956497
Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
An observational study of Extracorporeal Membrane Oxygenation Complication and Cardiopulmonary Arrest, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The data of patients undergo extracorporeal cardiopulmonary resuscitation (eCPR) will be collected and analyzed. This study will provide useful information about the indication, the start time and others to improve the outcome of ECPR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Cardiopulmonary Arrest
- What is being tested?
- extracorporeal membrane oxygenation (ECMO)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 (age>=18y) cardiac arrested patients accept ECPR treatment will be enrolled in the study.
Who may be able to join
- Age >=18y
- Cardiac arrested patients accept ECPR treatment
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Jun Xu, M.D., 15801578819, xujunfree@126.com
About this study
The data of patients undergo extracorporeal cardiopulmonary resuscitation (eCPR) will be collected and analyzed. This study will provide useful information about the indication, the start time and others to improve the outcome of ECPR.
- Being tested
- extracorporeal membrane oxygenation (ECMO)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
extracorporeal membrane oxygenation (ECMO)Device
ECMO under ongoing cardiopulmonary resuscitation (eCPR) in patients with refractory cardiac arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
the death rate of the patients
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (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 ComplicationStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Xu, MD, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956497
- Sponsor's protocol ID
- PUMCH-001
- Acronym
- ECPR-China
- Status last verified
- May 2021
- First submitted
- 8 Jul 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
- ClinicalTrials.gov ID
- NCT04956497
- Acronym / sponsor ID
- ECPR-China / PUMCH-001
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 2021 (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.
The data of patients undergo extracorporeal cardiopulmonary resuscitation (eCPR) will be collected and analyzed. This study will provide useful information about the indication, the start time and others to improve the outcome of ECPR.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (age>=18y) cardiac arrested patients accept ECPR treatment will be enrolled in the study.
Key inclusion criteria (2 listed)
- Age >=18y
- Cardiac arrested patients accept ECPR treatment
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| extracorporeal membrane oxygenation (ECMO)ECMO under ongoing cardiopulmonary resuscitation (eCPR) in patients with refractory cardiac arrest | Device | – |
Primary outcome
mortality rate
Time frame: 28 days
the death rate of the patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
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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. This study is not recruiting at the moment.
Jun Xu, MD study chair
Peking Union Medical College Hospital
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 Complication and Cardiopulmonary Arrest, run by Peking Union Medical College Hospital 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Xu, MD (15801578819, xunjunfree@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 28 days). 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 9 Jul 2021.