Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-26 @ 11:05 PM
Study NCT ID:
NCT02352805
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2015-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulopathy and SIRS During ECC in Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'human whole blood and blood plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2015-01-28', 'studyFirstSubmitQcDate': '2015-01-28', 'lastUpdatePostDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of the platelet activation marker "beta-thromboglobulin"', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Extracorporeal circulation, ventricular assist device'], 'conditions': ['Disorder of Circulatory System']}, 'descriptionModule': {'briefSummary': 'This observational clinical study investigates cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different extracorporeal circulation (ECC) and circulatory support devices under intensive care conditions.', 'detailedDescription': 'The complex interplay between the various factors contributing to the ECC-related coagulopathy and inflammation in intensive care settings is only poorly understood so far. Furthermore, it is unclear, how coagulopathy and inflammation shall be monitored and which anticoagulants may be employed to decrease complications associated with specific ECC systems. Therefore, the use of laboratory analyses, anticoagulation and anti-platelet therapy varies between different ECC systems and intensive care units.\n\nA better understanding of the mechanisms of the activation and interaction of platelets and leukocytes, plasmatic coagulation, complement, cytokines and endothelium will highlight starting-points to increase the safety and efficacy of ECC in intensive care medicine. The investigation of these phenomena in different ECC systems under clinical conditions is therefore the goal of this study.\n\nIn order to achieve the study goal, we will investigate cellular and plasmatic activation markers as well as proteins involved in coagulation and inflammation in patients being connected to different ECC systems under intensive care conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients undergoing implantation of extracorporeal circulation or mechanical circulatory support systems (ECLS / ECMO / LVAD / dialysis) due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases.\n* Patients undergoing cardiac surgery with extracorporeal circulation (ECC).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nNeed for therapy with extracorporeal circulation / circulatory support due to cardiac failure, or lung failure, or renal failure, or a combination of these diseases\n\nExclusion Criteria:\n\n1. History of previously diagnosed hereditary coagulation and/or platelet disorders\n2. Refusal to receive blood transfusion\n3. Participation in other clinical research studies involving evaluation of other investigational drugs or devices within 30 days of randomization\n4. Diagnosis of hepatitis B, hepatitis C, and HIV\n5. Age \\> 85 years'}, 'identificationModule': {'nctId': 'NCT02352805', 'briefTitle': 'Coagulopathy and SIRS During ECC in Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'A Comparative Clinical Study to Understand the Coagulopathy and Systemic Inflammation Associated With the Use of Extracorporeal Circulation in Intensive Care Patients', 'orgStudyIdInfo': {'id': 'COSIMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': '(1) veno-venous ECMO', 'description': 'ECMO - Patients being connected to veno-venous extracorporeal membrane oxygenation (ECMO)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(2) veno-arterial ECLS', 'description': 'ECLS - Patients being connected to veno-arterial extracorporeal life support (ECLS)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(3) LVAD (Heart Mate II)', 'description': 'LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate II)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(4) LVAD (Heart Ware)', 'description': 'LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Ware)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(5) LVAD (Impella)', 'description': 'LVAD - Patients being connected to a left ventricular assist device (LVAD) (Impella)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(6) Dialysis system', 'description': 'Patients being connected to a dialysis system', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(7) LVAD (Heart Mate III)', 'description': 'LVAD - Patients being connected to a left ventricular assist device (LVAD) (Heart Mate III)', 'interventionNames': ['Device: ECLS/ECC']}, {'label': '(8) HLM', 'description': 'HLM = Heart Lung Machine - patients undergoing coronary artery bypass grafting surgery and / or aortic valve replacement with cardiopulmonary bypass', 'interventionNames': ['Device: ECLS/ECC']}], 'interventions': [{'name': 'ECLS/ECC', 'type': 'DEVICE', 'description': 'Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery', 'armGroupLabels': ['(1) veno-venous ECMO', '(2) veno-arterial ECLS', '(3) LVAD (Heart Mate II)', '(4) LVAD (Heart Ware)', '(5) LVAD (Impella)', '(6) Dialysis system', '(7) LVAD (Heart Mate III)', '(8) HLM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Dept. of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Helene Häberle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tübingen, Dept. of Anesthesiology and Intensive Care Medicine, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}