Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 2:12 PM
Study NCT ID:
NCT03765866
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2016-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rotational Thromboelastometry Activated Transfusion In Trauma Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2018-12-03', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in number of blood products utilized at 24 hours', 'timeFrame': '24 hours from time of randomization', 'description': 'Number of blood products utilized during that time frame will be recorded to determine if change in resuscitation strategies result in measurable differences'}], 'secondaryOutcomes': [{'measure': 'Change in coagulation profile', 'timeFrame': '0 hours and 30 days', 'description': 'Analyze coagulation profiles in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy'}, {'measure': 'Change in inflammatory mediators', 'timeFrame': '0 hours and 30 days', 'description': 'Analyze inflammatory mediators in each resuscitation strategy to determine if there is a change in the mechanism of coagulopathy'}, {'measure': 'Changes in Resuscitation strategy-related adverse events', 'timeFrame': '30 days after admission', 'description': 'Rate of resuscitation strategies-related adverse events as a composite, including (transfusion related acute lung injury, transfusion associated circulatory overload, hyperkalemia, hypocalcemia, allergic reaction, hemolysis and transfusion transmitted infection)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['rotational thromboelastometry', 'viscoelastic test', 'coagulopathy', 'trauma', 'hemorrhage'], 'conditions': ['Trauma']}, 'referencesModule': {'references': [{'pmid': '24103457', 'type': 'BACKGROUND', 'citation': 'Schlimp CJ, Voelckel W, Inaba K, Maegele M, Schochl H. Impact of fibrinogen concentrate alone or with prothrombin complex concentrate (+/- fresh frozen plasma) on plasma fibrinogen level and fibrin-based clot strength (FIBTEM) in major trauma: a retrospective study. Scand J Trauma Resusc Emerg Med. 2013 Oct 8;21:74. doi: 10.1186/1757-7241-21-74.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial to compare viscoelastic (VE) guided resuscitation to fixed-ratio resuscitation in trauma patients with hemorrhagic shock on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation adverse events.', 'detailedDescription': 'This is an open labeled study as the VE guided resuscitation will be based on the visible VE results. Aim 1 will compare the number of blood products utilized in each resuscitation strategy. Aim 2 will analyze the coagulation and inflammatory mediators in each resuscitation strategy to determine if there is a difference in the mechanism of coagulopathy. Aim 3 will determine if the different resuscitation strategies have an effect on post resuscitation adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Trauma patient\n2. MTP Activation\n3. Only patients ≥ 14 years old\n4. Alive at 31 mins after arrival in ED\n\nExclusion Criteria:\n\n1. Transfer from OSH\n2. Received CPR for more than 5 mins\n3. Burned\n4. Pregnant or Prisoner\n5. Known DNR\n6. Jehovah's witness"}, 'identificationModule': {'nctId': 'NCT03765866', 'acronym': 'ROTATE-IT', 'briefTitle': 'Rotational Thromboelastometry Activated Transfusion In Trauma Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Viscoelastic Guided Goal Directed Resuscitation of Severely Injured Patients', 'orgStudyIdInfo': {'id': '022015-093'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Massive Transfusion Protocol Guided', 'description': 'Clinicians will only transfuse patients according to standard massive transfusion protocol (MTP)'}, {'type': 'EXPERIMENTAL', 'label': 'Thromboelastometry guided transfusion', 'description': 'Clinicians will transfuse patients according to ROTEM results.', 'interventionNames': ['Procedure: Thromboelastometry guided transfusion']}], 'interventions': [{'name': 'Thromboelastometry guided transfusion', 'type': 'PROCEDURE', 'description': 'Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP', 'armGroupLabels': ['Thromboelastometry guided transfusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75206', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Memorial Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Michael W. Cripps, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}