Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-02 @ 11:22 PM
Study NCT ID:
NCT02456467
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2015-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2015-05-26', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clot time', 'timeFrame': '1 day', 'description': 'Coagulation Function'}, {'measure': 'Clot Amplitude', 'timeFrame': '1 day', 'description': 'Coagulation Function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.', 'detailedDescription': "HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.\n\nA clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the University of Virginia Health System and will involve patients undergoing cardiac surgery requiring bypass."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants for this study will be recruited at UVA. The subject population will be representative of the local racial and ethnic population.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is scheduled for cardiac surgery involving bypass circuit\n* Subject is older than 18 years\n* Subject is willing to participate and he/she has signed a consent form\n\nExclusion Criteria:\n\n* Subject is unable to provide written informed consent\n* Subject is incarcerated at the time of the study\n* Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks\n* Patients with renal disease (defined as serum creatinine greater than 1.5 mg/dl)\n* Patients with history of active liver disease\n* Patients on emergency cases\n* Patients on heparin anticoagulation before the beginning of the study'}, 'identificationModule': {'nctId': 'NCT02456467', 'briefTitle': 'HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'HemoSonics-UVA Cardiac Surgery Clinical Study Protocol', 'orgStudyIdInfo': {'id': '17923:'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgery Patients', 'description': 'Intervention: Procedure: Blood specimen collection'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Danja Groves, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UVA Anesthesiology Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'HemoSonics LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Anesthesiology', 'investigatorFullName': 'Danja Groves, MD', 'investigatorAffiliation': 'University of Virginia'}}}}