Cardiac ArrestNCT04198792
Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
An observational study of Cardiac Arrest and Extracorporeal Membrane Oxygenation, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Arrest, Extracorporeal Membrane Oxygenation, Hypoxia-Ischemia, Brain
- How many people
- 700 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2010to 1 Jan 2030
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton
Who may be able to join
- ECMO-treated patients.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska Academy at Sahlgrenska University Hospital
Gothenburg, 41345
Bengt Redfors, MD, PhD, bengt.redfors@vgregion.se
Anna Henningsson, MD, anna.henningsson@vgregion.se
About this study
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this.
The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life.
Read more
Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors.
Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR.
Specific aim 2: To assess the sterility and function of pre-primed ECMO.
Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population.
Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.
Read the detailed description
Specific aim 1: The aim is to develop an ECPR prognostication tool and validate its performance. In development, possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR. Patients from the Gothenburg ECPR cohort are included in the development study. External validation with the ECMO patients from the Prague OHCA trial, following guidelines for validation studies, will follow, as well as external validation with further patients from Gothenburg.
Specific aim 2: Cardiohelp ECMO circuits are set up dry, followed by wet-priming and used in the ECMO treatments of the centre. The circuits are cultured at ECMO-initiation and the incidence of positive cultures is assessed. The effect of the pre-primed time on ECMO function is also assessed.
Specific aim 3: The predictive ability of the current guideline for neurological prognostication of comatose patients in the ICU after cardiac arrest, from the European Resuscitation Council, is assessed in the ECPR cohort of Gothenburg. The diagnostic performance of individual predictors as well as the total accuracy of the prediction will be assessed.
Specific aim 4: A Long-term (1-12 years) follow-up of the ECPR patients will be performed, to determine the long-term neuropsychological outcomes.
4 A: Life satisfaction after ECPR will be assessed along with anxiety, depression, fatigue, cognitive function, and physical activity. The impact of these factors on life satisfaction will also be evaluated. QUALY will be calculated.
4 B: Long-term neurocognitive function in ECPR patients will be assessed through comprehensive neuropsychological testing, using conventional CPR patients from the TTM2 trial as a control group.
The general ECMO population from 2004 of the center is included as a control group and positive cultures during their ECMO runs are documented.
- Being tested
- No intervention
- Medical subject headings
- Heart Arrest, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| ECPR patients | Patients that is put om ECMO during cardiac arrest Receives: Other: No intervention | |
| ECMO patients, non-ECPR | Patients that is put on ECMO due to circulatory failure but not cardiac arrest Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale (MRs)
Assessmenty of cognitive function. 0-6, where 0 is best.
Measured: 1 year
Performance of ECMO oxygenator function
Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed
Measured: 0-60 days
Positive cultures of pre-primed ECMO circuits
ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment
Measured: 0-90 days
Predictive ability of ERC neuro prognostication guidelines on ECPR patients
Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR
Measured: 1 year
Life Satisfaction
Visual Analog Scale 1-10. 10 is better.
Measured: 1-12 years
Euro Qualy - 5 dimension (EQ-5D-5L) VAS
Self-perceived health status. 0-100, where higher is better.
Measured: 3 months to 12 years
Neurocognitive function
Z-scores of verbal and visual function, episodic and visuospatial memory , processing speed and executive functions. 0 represents standardized population norm and ± 1 represent one standard deviation from that.
Measured: 3 months to 12 years after the ECPR-treatment
Positive blood Cultures
Infection rates in ECMO-patients
Measured: 1 month
Secondary outcomes (5)
MoCA
Assess cognitive function, higher is better. 0-30 where higher is better
Measured: 3 months to 12 years after the ECPR treatment
Hospital Anxiety and Depression Scale (HADS)
Two sub scales 0-21 which assess anxiety and depression, higer is worse
Measured: 3 months to 12 years
Mental Fatigue Scale
Assess fatigue 0-42 points. Higher is worse
Measured: 3 months to 12 years
modified Rankin Scale
physical function from 0-6 where 0 is best
Measured: 3 months to 12 years
Actual physical activity
Days per seven days with more than 30 minutes of physical activity
Measured: 3 months to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2010
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bengt Redfors, Sahlgrenska University Hospital
- Investigators
- Bengt Redfors, MD, PhD, Principal investigator, The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198792
- Sponsor's protocol ID
- GES
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2019
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bengtsson D, Jonsson B, Redfors B. Sterility and oxygenator function in pre-primed extracorporeal membrane oxygenation: A prospective clinical study. Resusc Plus. 2024 Jun 5;19:100680. doi: 10.1016/j.resplu.2024.100680. eCollection 2024 Sep.
PubMed 38912528Redfors B, Byttner A, Bengtsson D, Watson P, Lannemyr L, Lundgren P, Gabel J, Rawshani A, Henningsson A. The Pre-ECPR Score: Developing and Validating a Multivariable Prediction Model for Favorable Neurological Outcomes in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3018-3028. doi: 10.1053/j.jvca.2024.09.009. Epub 2024 Sep 17.
PubMed 39395854
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
- ClinicalTrials.gov ID
- NCT04198792
- Acronym / sponsor ID
- GES
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 13 Dec 2019 (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.
In ECPR, where CPR times often range from 30 to 120 minutes, only patients with good circulation during CPR survive, while non-survivors commonly suffer from anoxic brain injury. The selection process during CPR is challenging causing a general survival rate of just 2 out of 10, and the urgent need for better selection criteria has been emphasized. It it crucial to keep cardiac arrest times as short as possible, pre primed-ECMO can facilitate this.
The ECMO treatment and the long CPR times of ECPR can also affect the measurements of the neurologic prognostication guidelines after cardiac arrest, making its validity uncertain in this specific cohort. Further, the long-term neuropsychological follow-up is limited to a few patients, making it uncertain if ECPR gives the survivors good long-term life satisfaction or just a prolonged life.
Our overall aim is to optimize and improve the care pathway for ECPR patients by refining patient selection, assessing pre-primed ECMO, validating neurological prognostication guidelines, and understanding long-term outcomes and challenges faced by survivors.
Specific Aim 1: Evaluating predictors for good neurological outcomes in ECPR and to develop and validate (internally and externally) an evidence-based selection tool for ECPR.
Specific aim 2: To assess the sterility and function of pre-primed ECMO.
Specific aim 3: To evaluate the applicability of current guidelines for neurological prognostication after cardiac arrest in ECPR patients, and to assess the predictive value of individual and combined neurological tests in this specific patient population.
Specific aim 4: To determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction - by comprehensive follow-up visits with validated questionnaires and neuropsychology testing up to 12 years after the ECMO-treated cardiac arrest.
Detailed description
Specific aim 1: The aim is to develop an ECPR prognostication tool and validate its performance. In development, possible predictors for good neurological outcomes are prospectively gathered. The predictive ability of the predictors is tested in univariate and multivariable analysis, with the aim of improving patient selection for ECPR. Patients from the Gothenburg ECPR cohort are included in the development study. External validation with the ECMO patients from the Prague OHCA trial, following guidelines for validation studies, will follow, as well as external validation with further patients from Gothenburg.
Specific aim 2: Cardiohelp ECMO circuits are set up dry, followed by wet-priming and used in the ECMO treatments of the centre. The circuits are cultured at ECMO-initiation and the incidence of positive cultures is assessed. The effect of the pre-primed time on ECMO function is also assessed.
Specific aim 3: The predictive ability of the current guideline for neurological prognostication of comatose patients in the ICU after cardiac arrest, from the European Resuscitation Council, is assessed in the ECPR cohort of Gothenburg. The diagnostic performance of individual predictors as well as the total accuracy of the prediction will be assessed.
Specific aim 4: A Long-term (1-12 years) follow-up of the ECPR patients will be performed, to determine the long-term neuropsychological outcomes.
4 A: Life satisfaction after ECPR will be assessed along with anxiety, depression, fatigue, cognitive function, and physical activity. The impact of these factors on life satisfaction will also be evaluated. QUALY will be calculated.
4 B: Long-term neurocognitive function in ECPR patients will be assessed through comprehensive neuropsychological testing, using conventional CPR patients from the TTM2 trial as a control group.
The general ECMO population from 2004 of the center is included as a control group and positive cultures during their ECMO runs are documented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECPR patients | – | Other: No interventionPatients that is put om ECMO during cardiac arrest |
| ECMO patients, non-ECPR | – | Other: No interventionPatients that is put on ECMO due to circulatory failure but not cardiac arrest |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton
Key inclusion criteria (1 listed)
- ECMO-treated patients.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionNo intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest | Other | ECMO patients, non-ECPR, ECPR patients |
Primary outcome
Modified Rankin scale (MRs)
Time frame: 1 year
Assessmenty of cognitive function. 0-6, where 0 is best.
Performance of ECMO oxygenator function
Time frame: 0-60 days
Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed
Positive cultures of pre-primed ECMO circuits
Time frame: 0-90 days
ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment
Predictive ability of ERC neuro prognostication guidelines on ECPR patients
Time frame: 1 year
Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR
Life Satisfaction
Time frame: 1-12 years
Visual Analog Scale 1-10. 10 is better.
Euro Qualy - 5 dimension (EQ-5D-5L) VAS
Time frame: 3 months to 12 years
Self-perceived health status. 0-100, where higher is better.
Neurocognitive function
Time frame: 3 months to 12 years after the ECPR-treatment
Z-scores of verbal and visual function, episodic and visuospatial memory , processing speed and executive functions. 0 represents standardized population norm and ± 1 represent one standard deviation from that.
Positive blood Cultures
Time frame: 1 month
Infection rates in ECMO-patients
5 secondary outcomes
MoCA
Time frame: 3 months to 12 years after the ECPR treatment
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months to 12 years
Mental Fatigue Scale
Time frame: 3 months to 12 years
modified Rankin Scale
Time frame: 3 months to 12 years
Actual physical activity
Time frame: 3 months to 12 years
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 20 Jan 2026.
- Results publication: PubMed 38912528Bengtsson D, Jonsson B, Redfors B. Sterility and oxygenator function in pre-primed extracorporeal membrane oxygenation: A prospective clinical study. Resusc Plus. 2024 Jun 5;19:100680. doi: 10.1016/j.resplu.2024.100680. eCollection 2024 Sep.
- Results publication: PubMed 39395854Redfors B, Byttner A, Bengtsson D, Watson P, Lannemyr L, Lundgren P, Gabel J, Rawshani A, Henningsson A. The Pre-ECPR Score: Developing and Validating a Multivariable Prediction Model for Favorable Neurological Outcomes in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation. J Cardiothorac Vasc Anesth. 2024 Dec;38(12):3018-3028. doi: 10.1053/j.jvca.2024.09.009. Epub 2024 Sep 17.
- 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.
Bengt Redfors, MD, PhD principal investigator
The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden
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 Cardiac Arrest and Extracorporeal Membrane Oxygenation, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 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: looking for participants now, as of the sponsor's last update on 20 Jan 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 Sweden. 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 Bengt Redfors, MD, PhD (+46768445402, bengt.redfors@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (MRs) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04198792, which also lists 2 linked publications.
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 20 Jan 2026.