Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 3:04 AM
Study NCT ID:
NCT02826057
Status:
UNKNOWN
Last Update Posted:
2016-07-07
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Complement Lectin Pathway After Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}, {'id': 'D000080942', 'term': 'Post-Cardiac Arrest Syndrome'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007036', 'term': 'Hypothermia, Induced'}], 'ancestors': [{'id': 'D017679', 'term': 'Cryotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-04', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-07-04', 'lastUpdatePostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MASP-2 concentration in plasma', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'MASP-2 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'MASP-2 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'MASP-2 concentration in plasma compared with 30-day mortality'}, {'measure': 'MASP-2 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'MASP-1 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'MASP-1 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'MASP-1 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'MASP-1 concentration in plasma compared with 30-day mortality'}, {'measure': 'MASP-3 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'MASP-3 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'MASP-3 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'MASP-3 concentration in plasma compared with 30-day mortality'}, {'measure': 'Mannan-Binding-Lectin concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'Mannan-Binding-Lectin concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'Mannan-Binding-Lectin concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality'}, {'measure': 'MAp44 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'Map44 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'MAp44 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'MAp44 concentration in plasma compared with 30-day mortality'}, {'measure': 'MAp19 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'MAp19 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'MAp19 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'MAp19 concentration in plasma compared with 30-day mortality'}, {'measure': 'H-ficolin concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'H-ficolin concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'H-ficolin concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'H-ficolin concentration in plasma compared with 30-day mortality'}, {'measure': 'M-ficolin concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'M-ficolin concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'M-ficolin concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'M-ficolin concentration in plasma compared with 30-day mortality'}, {'measure': 'CL-L1 concentration in plasma', 'timeFrame': '24 hours, 48 hours and 72 hours'}, {'measure': 'CL-L1 concentration in plasma', 'timeFrame': '24 hours to 72 hours'}, {'measure': 'CL-L1 concentration in plasma', 'timeFrame': '24 hours, 48 hours, 72 hours', 'description': 'CL-L1 concentration in plasma compared with 30-day mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Out-of-Hospital Cardiac Arrest', 'Post Cardiac Arrest Syndrome']}, 'descriptionModule': {'briefSummary': 'This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.\n\nThe overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.\n\nThe specific aim is to evaluate:\n\n* the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest\n* the relation between concentration of plasma lectin pathway proteins and mortality\n* if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins\n\nThis study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"\n\nThe following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out-of-Hospital Cardiac Arrest of presumed cardiac cause\n* Return of spontaneous circulation (ROSC)\n* Glasgow Coma Score \\< 8\n* Age \\> 18 years and \\< 80 years\n\nExclusion Criteria:\n\n* \\> 60 minutes from the circulatory collapse to ROSC\n* Time interval \\> 4 hours from cardiac arrest to initiation of targeted temperature management\n* Terminal illness\n* Coagulation disorder\n* Unwitnessed asystolia\n* Cerebral performance category 3-4 before the cardiac arrest\n* Severe persistent cardiogenic shock\n* Pregnancy\n* Persistent cardiogenic shock (systolic bloodpressure \\< 80 despite inotropic treatment)\n* New apoplexy or cerebral hemorrhage\n* Lack of consent from the relatives\n* Lack of consent from the general practitioner\n* Lack of consent from the patient'}, 'identificationModule': {'nctId': 'NCT02826057', 'briefTitle': 'The Complement Lectin Pathway After Cardiac Arrest', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest', 'orgStudyIdInfo': {'id': '12345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '24 hour of targeted temperature management', 'description': 'Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)', 'interventionNames': ['Other: Targeted temperature management (33 degree Celsius)']}, {'type': 'EXPERIMENTAL', 'label': '48 hour of targeted temperature management', 'description': 'Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)', 'interventionNames': ['Other: Targeted temperature management (33 degree Celsius)']}], 'interventions': [{'name': 'Targeted temperature management (33 degree Celsius)', 'type': 'OTHER', 'armGroupLabels': ['24 hour of targeted temperature management', '48 hour of targeted temperature management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Biomedicine, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Anesthesiology and Intensive Care, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Clinical Biochemistry, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}