Extracorporeal Cardiopulmonary ResuscitationMOFENCT03592810
Observational Study to Assess Optimal ECPR Settings After Resuscitation
An observational study of Extracorporeal Cardiopulmonary Resuscitation and Cardiac Arrest, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Extracorporeal Cardiopulmonary Resuscitation, Cardiac Arrest
- What is being tested?
- Settings of the extracorporeal membrane oxygenation (ECMO)
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jul 2018to 30 Sep 2020
- 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 to 70 years
- 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
- Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement)
- Age>18 and < 70 years
- Duration of low-flow < 60 min before decision to proceed with ECPR
- High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC)
- Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG)
- Cerebral oxymetry monitoring initiated during CPR preceding ECPR
Who cannot join
- Patients with a GCS<15 before CPR.
- Known pre-arrest cerebral performance category CPC ≥ 3
- Presumed noncardiac cause
- Unwitnessed collapse
- Suspected or confirmed pregnancy
- ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (EMS) team
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- Conscious patient
- Known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
- Suspected or confirmed acute stroke
- Known severe chronic organ dysfunction or other limitations to therapy
- "Do not resuscitate" order or other circumstances that make 180 day survival unlikely
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation
Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain.
Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR.
Read more
Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.
Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.
- Being tested
- Settings of the 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.
Settings of the extracorporeal membrane oxygenation (ECMO)Other
Also called Measurements of cerebral saturation
Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score
| Study group | Role | What they receive |
|---|---|---|
| ECPR | All patients who received ECMO placement during cardiopulmonary resuscitation (ECPR) Receives: Other: Settings of the extracorporeal membrane oxygenation (ECMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPC score 6 months
To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* ≤ 2
Measured: 6 months
Secondary outcomes (5)
CPC score discharge
Parameters correlated with a CPC* ≤ 2
Measured: 6 months
Glasgow coma scale (GCS) day 28
Parameters correlated with a GCS>13
Measured: 6 months
GCS total
Parameters correlated with a GCS > 13
Measured: 6 months
28 day mortality
Parameters correlated to 28 days mortality
Measured: 6 months
Hospital survival
Parameters correlated to hospital survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start18 Jul 2018
- Primary completion1 Mar 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Cardiopulmonary ResuscitationStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loes Mandigers, MD, Erasmus Medical Center
- Investigators
- Dinis dos Reis Miranda, PhD, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592810
- Sponsor's protocol ID
- NL60632.078.17
- Acronym
- MOFE
- Status last verified
- Feb 2021
- First submitted
- 19 Jun 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Observational Study to Assess Optimal ECMO Settings During the First Hours of Extracorporeal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT03592810
- Acronym / sponsor ID
- MOFE / NL60632.078.17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 19 Jul 2018 (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.
Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain.
Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR.
Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.
Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECPR | – | Other: Settings of the extracorporeal membrane oxygenation (ECMO)All patients who received ECMO placement during cardiopulmonary resuscitation (ECPR) |
Who may qualify
- Ages
- 18 to 70 years
- 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 (6 listed)
- Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement)
- Age>18 and < 70 years
- Duration of low-flow < 60 min before decision to proceed with ECPR
- High quality CPR (defined as end-tidal carbon dioxide (CO2et) >10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC)
- Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG)
Key exclusion criteria (11 listed)
- Patients with a GCS<15 before CPR.
- Known pre-arrest cerebral performance category CPC ≥ 3
- Presumed noncardiac cause
- Unwitnessed collapse
- Suspected or confirmed pregnancy
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 |
|---|---|---|
| Settings of the extracorporeal membrane oxygenation (ECMO)Also: Measurements of cerebral saturationCompare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score | Other | ECPR |
Primary outcome
CPC score 6 months
Time frame: 6 months
To prospectively identify parameters correlated with Cerebral Performance Category (CPC)* ≤ 2
5 secondary outcomes
CPC score discharge
Time frame: 6 months
Glasgow coma scale (GCS) day 28
Time frame: 6 months
GCS total
Time frame: 6 months
28 day mortality
Time frame: 6 months
Hospital survival
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Dinis dos Reis Miranda, PhD, MD principal investigator
Erasmus Medical Center
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 Cardiopulmonary Resuscitation and Cardiac Arrest, run by Erasmus Medical Center at 1 site in Netherlands.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 23 Feb 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 Netherlands. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CPC score 6 months (time frame: 6 months). 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 Feb 2021.