Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 11:40 AM
Study NCT ID:
NCT04198792
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost', 'timeFrame': '3 month', 'description': 'The in hospital cost of the treatment for the patients, in Swedish kronor.'}], 'primaryOutcomes': [{'measure': 'Survival with Cerebral Performance Category 1 or 2.', 'timeFrame': '1 year', 'description': 'Good neurological outcome in ECPR-patients'}, {'measure': 'Physicians Global Assessment to measure quality of life', 'timeFrame': '1-15 years', 'description': 'Quality of Life in survivors after ECPR and ECMO without cardiac arrest, Measured with in depth interviews'}, {'measure': 'Positive blood Cultures', 'timeFrame': '1 month', 'description': 'Infection rates in ECMO-patients'}, {'measure': 'Euro Qualy - 5 dimension (EQ-5D)', 'timeFrame': '1-7 years', 'description': 'Assesment of quality of life'}, {'measure': 'Cerebral Performance Scale (CPC)', 'timeFrame': '1-7 years', 'description': 'Assessment of cerebral performance. 1-5, where 1-2 is considered good outcome'}, {'measure': 'Modified Rankin scale (MRs)', 'timeFrame': '1-7 years', 'description': 'Assessmenty of cognitive function. 0-6, where 0 is best.'}, {'measure': 'Trailmaking test', 'timeFrame': '1-7 years', 'description': 'Assessmenty of cognitive function. Shorter time is better.'}, {'measure': 'Short Form -36 (SF-36)', 'timeFrame': '1-7 years', 'description': 'Quality of life. 8 scaled scores from 0-100, where 100 is best.'}, {'measure': 'New York heart association class (NYHA class)', 'timeFrame': '1-7 years', 'description': 'Assessment of physical function.1-4, where 1 is best'}, {'measure': 'Positive cultures of pre-primed ECMO circuits', 'timeFrame': '0-90 days', 'description': 'ECMO circuits is pre-primed and cultures taken at the start of ECMO treatment'}, {'measure': 'Performance of ECMO oxygenator function', 'timeFrame': '0-60 days', 'description': 'Oxygenator resistance, and the needed FiO2 and sweep gas flow will be assessed'}, {'measure': 'Predictive ability of ERC neuro prognostication guidelines on ECPR patients', 'timeFrame': '1 year', 'description': 'Diagnostic performance and ROC analysis of individual and total ERC predictors on outcome in ECPR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest', 'Extracorporeal Membrane Oxygenation', 'Hypoxia-Ischemia, Brain']}, 'referencesModule': {'references': [{'pmid': '38912528', 'type': 'RESULT', 'citation': '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': '39395854', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nOur 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.\n\nSpecific 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.\n\nSpecific aim 2: To assess the sterility and function of pre-primed ECMO.\n\nSpecific 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.\n\nSpecific 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 10 years after the ECMO-treated cardiac arrest', 'detailedDescription': '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.\n\nSpecific 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.\n\nSpecific 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.\n\nSpecific aim 4: Long-term follow-up will be assessed for the ECPR patients, to determine the long-term neuropsychological outcomes, identify the problems survivors experience in daily life, and assess life satisfaction. QUALY will be calculated.\n\nThe general ECMO population from 2004 of the center is included as a control group and positive cultures during their ECMO runs are documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ECPR Group: Patients who is put on ECMO during cardiac arrest. ECMO Group: Patients who is put on ECMO with some ongoing circulaiton', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ECMO-treated patients.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04198792', 'briefTitle': 'Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Predictors for Survival and Good Neurological Outcome in E-CPR and Non CPR Treated Patients', 'orgStudyIdInfo': {'id': 'GES'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ECPR patients', 'description': 'Patients that is put om ECMO during cardiac arrest', 'interventionNames': ['Other: No intervention']}, {'label': 'ECMO patients, non-ECPR', 'description': 'Patients that is put on ECMO due to circulatory failure but not cardiac arrest', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest', 'armGroupLabels': ['ECMO patients, non-ECPR', 'ECPR patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Bengt Redfors, MD, PhD', 'role': 'CONTACT', 'email': 'bengt.redfors@vgregion.se'}, {'name': 'Anna Henningsson, MD', 'role': 'CONTACT', 'email': 'anna.henningsson@vgregion.se'}], 'facility': 'Sahlgrenska Academy at Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Bengt Redfors, MD, PhD', 'role': 'CONTACT', 'email': 'bengt.redfors@vgregion.se', 'phone': '+46768445402'}, {'name': 'Anna Henningsson, MD', 'role': 'CONTACT', 'email': 'anna.henningsson@vgregion.se', 'phone': '+46700922555'}], 'overallOfficials': [{'name': 'Bengt Redfors, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sahlgrenska Academy ar Sahlgrenska University Hospital, Gorhenburg, Sweden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Associate Professor', 'investigatorFullName': 'Bengt Redfors', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}