NCT04198792

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2010Jan 2030

Study Start

First participant enrolled

January 1, 2010

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

20 years

First QC Date

November 18, 2019

Last Update Submit

January 14, 2026

Conditions

Cardiac ArrestExtracorporeal Membrane OxygenationHypoxia-Ischemia, Brain

Outcome Measures

Primary Outcomes (8)

  • Modified Rankin scale (MRs)

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

    1 year

  • Performance of ECMO oxygenator function

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

    0-60 days

  • Positive cultures of pre-primed ECMO circuits

    ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment

    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

    1 year

  • Life Satisfaction

    Visual Analog Scale 1-10. 10 is better.

    1-12 years

  • Euro Qualy - 5 dimension (EQ-5D-5L) VAS

    Self-perceived health status. 0-100, where higher is better.

    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.

    3 months to 12 years after the ECPR-treatment

  • Positive blood Cultures

    Infection rates in ECMO-patients

    1 month

Secondary Outcomes (5)

  • MoCA

    3 months to 12 years after the ECPR treatment

  • Hospital Anxiety and Depression Scale (HADS)

    3 months to 12 years

  • Mental Fatigue Scale

    3 months to 12 years

  • modified Rankin Scale

    3 months to 12 years

  • Actual physical activity

    3 months to 12 years

Other Outcomes (5)

  • Cost

    3 month

  • Short Form -36 (SF-36)

    1-7 years

  • Trailmaking test

    1-7 years

  • +2 more other outcomes

Study Arms (2)

ECPR patients

Patients that is put om ECMO during cardiac arrest

Other: No intervention

ECMO patients, non-ECPR

Patients that is put on ECMO due to circulatory failure but not cardiac arrest

Other: No intervention

Interventions

No interventionOTHER

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

ECMO patients, non-ECPRECPR patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • ECMO-treated patients.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska Academy at Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38912528RESULT

  • 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.

    PMID: 39395854RESULT

MeSH Terms

Conditions

Heart ArrestHypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bengt Redfors, MD, PhD

    The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bengt Redfors, MD, PhD

CONTACT

+46768445402bengt.redfors@vgregion.se

Anna Henningsson, MD

CONTACT

+46700922555anna.henningsson@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

November 18, 2019

First Posted

December 13, 2019

Study Start

January 1, 2010

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)