Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-04 @ 7:02 PM
Study NCT ID:
NCT02379104
Status:
UNKNOWN
Last Update Posted:
2017-05-11
First Post:
2015-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-10', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Method comparison: linear regression analysis and bias estimation at medical decision limits', 'timeFrame': 'Parameter differences assessed at time of blood sampling'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Blood Coagulation Disorders']}, 'descriptionModule': {'briefSummary': 'ROTEM® sigma is a new thromboelastometric coagulation analysis system. The new system is fully automated allowing for a simple and safe operation compared to its predecessor model ROTEM® delta.\n\nMethod comparison of ROTEM® sigma with predecessor model ROTEM® delta) - confirmation of equality.\n\nConfirmation of reference intervals of the ROTEM® systems.', 'detailedDescription': 'The main innovation of ROTEM® sigma is the development of a sample handler and a cartridge allowing for a of full automated test operation. As in ROTEM® delta four different tests can be run simultaneously on the four channels of the analyser.\n\nWhereas the tests in ROTEM® delta are performed manually by pipetting a blood sample and liquid system reagents, in ROTEM® sigma the reagents are contained in freeze dried pellet form in a cartridge. Test operation is performed by inserting a cartridge and attaching a blood sample to the analyser.\n\nThe five available ROTEM® tests INTEM, EXTEM, FIBTEM, APTEM, and HEPTEM are contained in different combinations in two cartridge configurations:\n\n* Cartridge type 1 including INTEM, EXTEM, FIBTEM, APTEM\n* Cartridge type 2 including INTEM, EXTEM, FIBTEM, HEPTEM\n\nAim of the study is the performance evaluation of the new ROTEM® sigma coagulation analyzer in comparison to the current ROTEM® delta thromboelastometry system.\n\nAs a valid method comparison requires test results that cover the whole measurement range of the test system it is also necessary to include acute bleeding and emergency patients in the study. Only the inclusion of acute bleeding and emergency patients will produce strong pathologic test results allowing for a valid evaluation of the test system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients\n* Healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Age ≥ 18 years\n* Informed written consent\n* Patients with an acute bleeding during surgery\n* Or: trauma patients with acute bleeding\n* Or: hypercoagulable (above normal fibrinogen) patients at the ICU\n\nHealthy Volunteers:\n\n* Adult healthy individuals (≥ 18 years)\n* Written informed consent\n\nExclusion Criteria:\n\nPatients:\n\n• none\n\nHealthy Volunteers:\n\n* Any indications of alcohol or illegal drug abuse\n* Any chronic disease with possible effect on the coagulation (liver disease, coronary heart disease)\n* Any acute illness within the last 14 days\n* Any hemostasis associated disease (myocardial infarction, thrombosis , stroke etc.) within the last year\n* Intake of any coagulation affecting medication (aspirin, pain-killers, anti-rheumatic drugs, marcumar, platelet inhibitors) within the last 14 days\n* Females only: known pregnancy\n* Females only: breast feeding\n* Any indication for any hemostasis disorder as interrogated by a specific history of bleeding tendencies'}, 'identificationModule': {'nctId': 'NCT02379104', 'acronym': 'ROSI-EVA', 'briefTitle': 'ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tem Innovations GmbH'}, 'officialTitle': 'ROTEM® Sigma Performance Evaluation - Method Comparison With Predicate Device and Reference Intervals', 'orgStudyIdInfo': {'id': 'RSE2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'Healthy volunteers fulfilling inclusion/exclusion criteria for reference interval sample group are tested with ROTEM sigma', 'interventionNames': ['Device: ROTEM sigma']}, {'label': 'Patients with expected coagulopathy', 'description': 'Patients with expected bleeding and coagulation problems during elective surgery or at the ICU, or trauma patients are tested with ROTEM sigma and ROTEM delta comparatively', 'interventionNames': ['Device: ROTEM sigma']}], 'interventions': [{'name': 'ROTEM sigma', 'type': 'DEVICE', 'otherNames': ['ROTEM delta'], 'description': 'Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel', 'armGroupLabels': ['Healthy Volunteers', 'Patients with expected coagulopathy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32789', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Francis, MD PhD', 'role': 'CONTACT', 'email': 'john.francis@flhosp.org'}, {'name': 'John Francis, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Florida Hospital Center for Thrombosis Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ken Tanaka, MD MSc', 'role': 'CONTACT', 'email': 'ktanaka@anes.umm.edu'}, {'name': 'Ken Tanaka, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hugh Hemmings, MD PhD', 'role': 'CONTACT', 'email': 'mls9004@med.cornell.edu'}, {'name': 'Hugh Hemmings, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology Weill Cornell Medical College New York-Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Dietmar Fries, Prof. Dr.', 'role': 'CONTACT', 'email': 'dietmar.fries@uki.at', 'phone': '+43 (0)512 504 80455'}, {'name': 'Dietmar Fries, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medi. Medical University Innsbruck Department of General and Surgical Intensive Care Medicine, Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Oliver Theusinger, PD Dr.', 'role': 'CONTACT', 'email': 'oliver.theusinger@usz.ch', 'phone': '+41 (0)44 255 2710'}, {'name': 'Oliver Theusinger, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Anaesthesiology, Section Anaesthesiology, Intensive Care Medicine and OR-Management University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Volker Friemert, Dr.', 'role': 'CONTACT', 'email': 'volker-joachim.friemert@tem-innovations.de', 'phone': '+49 89 454295', 'phoneExt': '11'}, {'name': 'Klaus Görlinger, Dr.', 'role': 'CONTACT', 'email': 'klaus.goerlinger@tem-international.de', 'phone': '+49 1726596069'}], 'overallOfficials': [{'name': 'Volker Friemert, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Tem Innovations GmbH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tem Innovations GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}