Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-03-27 @ 8:41 AM
Study NCT ID:
NCT04343404
Status:
COMPLETED
Last Update Posted:
2020-06-29
First Post:
2020-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-25', 'studyFirstSubmitDate': '2020-04-08', 'studyFirstSubmitQcDate': '2020-04-08', 'lastUpdatePostDateStruct': {'date': '2020-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retrospective description of COVID-19 patients receiving respiratory ECMO-VV supplementation and what happens to them', 'timeFrame': 'Files analysed retrospectily from March 1st, 2020 to April 15, 2020 will be examined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Distress Syndrome', 'ARDS', 'SARS-COV-2', 'Extracorporeal membrane oxygenation', 'ECMO', 'Veno-venous ECMO'], 'conditions': ['Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'Describe COVID-19 patients who are receiving ECMO-VV respiratory replacement and what happens to them.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with a COVID-19 diagnosis by RT-PCR', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient over the age of 18;\n* Diagnostic COVID-19 by RT-PCR;\n* Hospitalisation in resuscitation for the management of complications related to COVID-19\n* Implanted ECMO-VV during hospitalisation;\n* Patient agreeing to participate in the study\n\nExclusion Criteria:\n\n* Sujet under guardianship or trusteeship\n* Sujet under safeguard of justice'}, 'identificationModule': {'nctId': 'NCT04343404', 'acronym': 'ECMO-COVID-19', 'briefTitle': 'Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'STUDY ECMO-COVID-19 : Place of ECMO in the Management of Severe Refractory ARDS Associated With Covid-19', 'orgStudyIdInfo': {'id': '7772'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Pierre-Emmanuel FALCOZ, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Service de Chirurgie Thoracique Nouvel Hôpital Civl Hôpitaux Univesitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}