Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-01 @ 11:21 PM
Study NCT ID:
NCT04312958
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2020-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantra QStat in Trauma and Liver Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2020-03-15', 'studyFirstSubmitQcDate': '2020-03-15', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results', 'timeFrame': 'Upon arrival of trauma subject to the emergency department', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results', 'timeFrame': 'Baseline, immediately before the start of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results', 'timeFrame': 'During anhepatic phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results', 'timeFrame': 'During post-reperfusion phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results', 'timeFrame': 'Upon arrival of trauma subject to the emergency department', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results', 'timeFrame': 'Baseline, immediately before the start of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results', 'timeFrame': 'During anhepatic phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results', 'timeFrame': 'During post-reperfusion phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results', 'timeFrame': 'Upon arrival of trauma subject to the emergency department', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results', 'timeFrame': 'Baseline, immediately before the start of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results', 'timeFrame': 'During anhepatic phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results', 'timeFrame': 'During post-reperfusion phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results', 'timeFrame': 'Upon arrival of trauma subject to the emergency department', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results', 'timeFrame': 'Baseline, immediately before the start of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results', 'timeFrame': 'During anhepatic phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}, {'measure': 'Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results', 'timeFrame': 'During post-reperfusion phase of liver transplant surgery', 'description': 'Coagulation function assessed by Quantra and ROTEM Delta'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Viscoelastic testing', 'Coagulation', 'Trauma', 'Liver Transplant', 'Quantra', 'QStat'], 'conditions': ['Hemorrhage', 'Trauma', 'Liver Transplant']}, 'referencesModule': {'references': [{'pmid': '40486089', 'type': 'DERIVED', 'citation': 'Moore EE, Michelson EA, Gabriel-Ramos K, Cripps MW, Flores A, Vandyck K, Thurston B, Brennan M, Viola F, Winegar DA. Multicenter evaluation of the Quantra with the QStat Cartridge in adult trauma patients. Trauma Surg Acute Care Open. 2025 Jun 3;10(2):e001672. doi: 10.1136/tsaco-2024-001672. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.', 'detailedDescription': "The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.\n\nThis multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Potential study participants will be adult (\\>18 years) trauma patients or patients undergoing liver transplant surgery.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is \\> 18 years\n* Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.\n* Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.\n\nExclusion Criteria:\n\n* Subject is younger than 18 years of age\n* Subject is pregnant.\n* Subject is incarcerated at the time of the study.\n* Subject is currently enrolled in a distinct study that might confound the result of the proposed study\n* Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks."}, 'identificationModule': {'nctId': 'NCT04312958', 'briefTitle': 'Quantra QStat in Trauma and Liver Transplant', 'organization': {'class': 'INDUSTRY', 'fullName': 'HemoSonics LLC'}, 'officialTitle': 'Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation', 'orgStudyIdInfo': {'id': 'HEMCS-032'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Trauma patients', 'description': 'Trauma patients experiencing traumatic injuries requiring a full trauma team response.', 'interventionNames': ['Diagnostic Test: Quantra System']}, {'label': 'Liver transplant patients', 'description': 'Patients undergoing liver transplant surgery.', 'interventionNames': ['Diagnostic Test: Quantra System']}], 'interventions': [{'name': 'Quantra System', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Quantra QStat Cartridge'], 'description': 'Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.', 'armGroupLabels': ['Liver transplant patients', 'Trauma patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Zuckerberg San Francisco General Hospital and Trauma Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '28037', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '98109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Spartanburg Regional Medical Center', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HemoSonics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}