Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
NCT ID: NCT04198792
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2010-01-01
2030-01-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ECPR patients
Patients that is put om ECMO during cardiac arrest
No intervention
No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
ECMO patients, non-ECPR
Patients that is put on ECMO due to circulatory failure but not cardiac arrest
No intervention
No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
Interventions
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No intervention
No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
16 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Bengt Redfors
MD, PhD, Associate Professor
Principal Investigators
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Bengt Redfors, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden
Locations
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Sahlgrenska Academy at Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Redfors 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.
Other Identifiers
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GES
Identifier Type: -
Identifier Source: org_study_id
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