Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-11 @ 2:10 AM
Study NCT ID:
NCT03380767
Status:
WITHDRAWN
Last Update Posted:
2021-03-03
First Post:
2017-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pragmatic randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of financial support', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2017-12-17', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fresh frozen plasma consumption', 'timeFrame': '3 years', 'description': 'In the POC group plasma consumption is estimated 20% less than in conventional assays group'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days', 'description': '28 days mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['trauma-induced coagulopathy'], 'conditions': ['Trauma, Multiple', 'Coagulopathy', 'Massive Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '27894492', 'type': 'BACKGROUND', 'citation': 'Gonzalez E, Moore EE, Moore HB. Management of Trauma-Induced Coagulopathy with Thrombelastography. Crit Care Clin. 2017 Jan;33(1):119-134. doi: 10.1016/j.ccc.2016.09.002.'}, {'pmid': '26720428', 'type': 'BACKGROUND', 'citation': 'Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.'}, {'pmid': '25686465', 'type': 'BACKGROUND', 'citation': 'Hunt H, Stanworth S, Curry N, Woolley T, Cooper C, Ukoumunne O, Zhelev Z, Hyde C. Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) for trauma induced coagulopathy in adult trauma patients with bleeding. Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010438. doi: 10.1002/14651858.CD010438.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).\n\nPOC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: all adult (\\> 18 years old) trauma patients treated in our Emergency Department with a TASH score \\> 18\n\nExclusion Criteria:\n\n* dead on arrival\n* no blood product administered after randomization'}, 'identificationModule': {'nctId': 'NCT03380767', 'acronym': 'VISCOTRAUMA', 'briefTitle': 'Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.', 'organization': {'class': 'OTHER', 'fullName': 'A.O. Ospedale Papa Giovanni XXIII'}, 'officialTitle': 'Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.', 'orgStudyIdInfo': {'id': 'Trauma Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'POC group', 'description': 'In this group, patients will be treated according to the information gathered by TEG or ROTEM assays.', 'interventionNames': ['Procedure: Trauma-induced coagulopathy treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Conventional group', 'description': 'In this group, patients will be treated according to the information gathered by conventional laboratory assays (platelet count, fibrinogen level, PT or INR and d dimer for fibrinolysis)', 'interventionNames': ['Procedure: Trauma-induced coagulopathy treatment']}], 'interventions': [{'name': 'Trauma-induced coagulopathy treatment', 'type': 'PROCEDURE', 'description': 'Transfusion as needed according to the assay methodology', 'armGroupLabels': ['Conventional group', 'POC group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'state': 'BG', 'country': 'Italy', 'facility': 'Ospedale Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O. Ospedale Papa Giovanni XXIII', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending General Surgeon', 'investigatorFullName': 'Stefano Magnone', 'investigatorAffiliation': 'A.O. Ospedale Papa Giovanni XXIII'}}}}