Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-25 @ 11:53 PM
Study NCT ID:
NCT04107818
Status:
COMPLETED
Last Update Posted:
2024-05-22
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009104', 'term': 'Multiple Trauma'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-09-26', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clotting time (CT) in EX-test and EXTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in clotting time measured by EX-test and EXTEM'}, {'measure': 'Clot formation time (CFT) in EX-test and EXTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in clot formation time measured by EX-test and EXTEM'}, {'measure': 'alfa angle in EX-test and EXTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in alfa angle measured by EX-test and EXTEM'}, {'measure': 'maximum clot firmness (MCF) in EX-test and EXTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in maximum clot firmness measured by EX-test and EXTEM'}, {'measure': 'maximum lysis (ML) in EX-test and EXTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'maximum lysis difference in MCF measured by EX-test and EXTEM'}, {'measure': 'clotting time (CT) FIB-test and FIBTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in clotting time measured by FIB-test and FIBTEM'}, {'measure': 'clot formation time (CFT) FIB-test and FIBTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in clot formation time measured by FIB-test and FIBTEM'}, {'measure': 'maximum clot firmness (MCF) FIB-test and FIBTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in maximum clot firmness measured by FIB-test and FIBTEM'}, {'measure': 'alfa angle FIB-test and FIBTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in alfa angle measured by FIB-test and FIBTEM'}, {'measure': 'maximum lysis (ML) FIB-test and FIBTEM', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'difference in maximum lysis measured by FIB-test and FIBTEM'}], 'secondaryOutcomes': [{'measure': 'patient temperature', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'effect of patients´ temperature on results of measurements'}, {'measure': 'maximum clot firmness (MCF) FIB-test and Clauss method', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of maximum clot firmness with blod fibrinogen level'}, {'measure': 'maximum clot firmness (MCF) FIBTEM and Clauss method', 'timeFrame': 'through study completion, an average of 3 months', 'description': 'correlation of maximum clot firmness with blod fibrinogen level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polytrauma', 'coagulopathy', 'viscoelastic tests'], 'conditions': ['Polytrauma', 'Coagulation Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the differences and interchangeability in measurements of viscoelastic tests of coagulation by two different devices in adult trauma patients.', 'detailedDescription': 'The study will commence following the Approval by The Ethics Research Committee. All patients admitted to our emergency department for trauma from the 1st of October 2019 to the 31st of January 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. Viscoelastic tests of coagulation will be performed on ROTEM® Delta and ClotPro® simultaneously. We will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for test of extrinsic pathway(EX-test) on ClotPro® vs. test for extrinsic pathway (EXTEM) on ROTEM® Delta. Further we will compare values of clotting time (CT), clot formation time (CFT), alfa angle, maximum clot firmness (MCF) and maximum lysis (ML) for thromboelastometry of fibrinogen (FIB-test) on ClotPro® vs. thromboelastometry of fibrinogen (FIBTEM) on ROTEM® Delta. The secondary outcome will be to describe the dependence of measurement on temperature of patient.\n\nStudy data will be entered in study form. The measurements can be repeated in time. The indication for next measurement is fully on treating physician.\n\nDifferences in estimated viscoelastic coagulation parameters and interchangeability of two devices will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to emnergency department for severe trauma.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* polytrauma with Injury severity score ≥ 16\n\nExclusion Criteria:\n\n* pregnancy\n* anticoagulant therapy\n* antiplatelet therapy\n* coagulation disorders'}, 'identificationModule': {'nctId': 'NCT04107818', 'acronym': 'ROTCLOT', 'briefTitle': 'Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Masaryk University'}, 'officialTitle': 'Comparison of Viscoelastic Measurement by ROTEM® Delta and ClotPro® in Trauma Patients. Prospective Observational Study.', 'orgStudyIdInfo': {'id': 'CT0022019'}}, 'contactsLocationsModule': {'locations': [{'zip': '62500', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno and Masaryk University Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}], 'overallOfficials': [{'name': 'Roman Gal, MD., PhD.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Brno and Masaryk University Brno'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masaryk University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brno University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}