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NCT Number: NCT04198792

Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients

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.

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Key information

Conditions

Cardiac Arrest Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Extracorporeal Membrane Oxygenation Heart Arrest Heart Diseases Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska Academy at Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location status: Recruiting

Location contact

Anna Henningsson, MD

CONTACT

[email protected]

Bengt Redfors, MD, PhD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ECMO-treated patients.

Exclusion criteria

  • None

Treatment and study plan

No intervention

Other

No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest

Primary outcomes

  1. Modified Rankin scale (MRs)

    Time frame: 1 year

    Assessmenty of cognitive function. 0-6, where 0 is best.

  2. Performance of ECMO oxygenator function

    Time frame: 0-60 days

    Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed

  3. 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

  4. 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

  5. Life Satisfaction

    Time frame: 1-12 years

    Visual Analog Scale 1-10. 10 is better.

  6. 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.

  7. 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.

  8. Positive blood Cultures

    Time frame: 1 month

    Infection rates in ECMO-patients

Secondary outcomes

  1. MoCA

    Time frame: 3 months to 12 years after the ECPR treatment

    Assess cognitive function, higher is better. 0-30 where higher is better

  2. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 months to 12 years

    Two sub scales 0-21 which assess anxiety and depression, higer is worse

  3. Mental Fatigue Scale

    Time frame: 3 months to 12 years

    Assess fatigue 0-42 points. Higher is worse

  4. modified Rankin Scale

    Time frame: 3 months to 12 years

    physical function from 0-6 where 0 is best

  5. Actual physical activity

    Time frame: 3 months to 12 years

    Days per seven days with more than 30 minutes of physical activity

Other outcomes

  1. Cost

    Time frame: 3 month

    The in hospital cost of the treatment for the patients, in Swedish kronor.

  2. Short Form -36 (SF-36)

    Time frame: 1-7 years

    Quality of life. 8 scaled scores from 0-100, where 100 is best.

  3. Trailmaking test

    Time frame: 1-7 years

    Assessmenty of cognitive function. Shorter time is better.

  4. New York heart association class (NYHA class)

    Time frame: 1-7 years

    Assessment of physical function.1-4, where 1 is best

  5. Euro-Qualy-5D-5L

    Time frame: 3 moths to 12 years

    Quality of life assessment, higher is better. Swedish value set -0.33 - 1.00

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Henningsson, MD

CONTACT

[email protected]

+46700922555

Bengt Redfors, MD, PhD

CONTACT

[email protected]

+46768445402

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Important dates

Study start
2010
Primary completion
2030
Study completion
2030
First posted
Dec 13, 2019
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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