Extracorporeal Membrane OxygenationNCT02748668
Extracorporeal Membrane Oxygenation (ECMO): Blood Cells
An observational study of Extracorporeal Membrane Oxygenation, run by Corewell Health West at 1 site in United States.
Trial summary
The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation
- What is being tested?
- Blood specimen collection
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2015to 23 Aug 2023
- How long will I take part?
- 8 Days
- 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: 500 patients on ECMO and 100 control patients will be enrolled into the study.
Who may be able to join
- Greater than or equal to 18 years of age
- Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.
- Greater than 18 years of age
- Without any known cardiovascular, lung, or autoimmune disease.
Who cannot join
- Subject is less than 18 years of age
- Known prisoner
- Control Subjects:
- Less than or equal to 18 years of age
- Known cardiovascular, lung, or autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracorporeal Membrane Oxygenation: Blood Cells
The objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.
- Conditions
- Extracorporeal Membrane Oxygenation
- Being tested
- Blood specimen collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood specimen collectionOther
| Study group | Role | What they receive |
|---|---|---|
| ECMO | No intervention. Blood specimen collection. Receives: Other: Blood specimen collection | |
| Control | No intervention. Blood specimen collection. Receives: Other: Blood specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start20 Jan 2015
- Primary completion23 Aug 2023
- Study completion23 Aug 2023
Why it stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Collaborators
- Van Andel Research Institute
- Responsible party
- Principal investigator, Renzo Loyaga Rendon, Corewell Health West
- Investigators
- Renzo Loyaga-Rendon, MD,PhD, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748668
- Sponsor's protocol ID
- 2014-255
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2016
- Last updated
- 5 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracorporeal Membrane Oxygenation: Blood Cells
- ClinicalTrials.gov ID
- NCT02748668
- Acronym / sponsor ID
- 2014-255
- Conditions
- Extracorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was not able to achieve primary objective and there is no intention to work towards its achievement
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Collaborators
- Van Andel Research Institute
- Study start
- 20 Jan 2015 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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 objective of the study is to predict outcomes of patients on extracorporeal membrane oxygenation (ECMO) therapy by correlating cytokines and inflammatory cell patterns to clinical outcomes using data collected in the ECMO Registry at Spectrum Health.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 8 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO | – | Other: Blood specimen collectionNo intervention. Blood specimen collection. |
| Control | – | Other: Blood specimen collectionNo intervention. Blood specimen collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 patients on ECMO and 100 control patients will be enrolled into the study.
Key inclusion criteria (4 listed)
- Greater than or equal to 18 years of age
- Subject presents to the CTICU at Butterworth Campus, Spectrum Health and is critically ill in the ICU needing ECMO therapy.
- Greater than 18 years of age
- Without any known cardiovascular, lung, or autoimmune disease.
Key exclusion criteria (5 listed)
- Subject is less than 18 years of age
- Known prisoner
- Less than or equal to 18 years of age
- Known cardiovascular, lung, or autoimmune disease
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 |
|---|---|---|
| Blood specimen collection | Other | Control, ECMO |
Primary outcome
All cause mortality
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
Renzo Loyaga-Rendon, MD,PhD principal investigator
Corewell Health West
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, run by Corewell Health West at 1 site in United States.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jun 2024. 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 United States. 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?
The study was stopped early (reason given: Study was not able to achieve primary objective and there is no intention to work towards its achievement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 1 year). 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 5 Jun 2024.