Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 4:31 AM
Study NCT ID:
NCT05295693
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2022-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '2 x 2.7mL of full blood for coagulation testing with the Quantra System. Blood samples will not be stored or used for other testing.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-03-15', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Quantra vs TEG_Fibrinogen_Function1', 'timeFrame': '30 minutes during anesthesia, prior to separation from CPB', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (FCS) with TEG (K time \\& alpha angle)'}, {'measure': 'Correlation Quantra vs TEG_Fibrinogen_Function1', 'timeFrame': '30 minutes during anesthesia, after coagulation products were given', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (FCS) with TEG (K time \\& alpha angle)'}, {'measure': 'Correlation Quantra vs TEG_Fibrinogen_Function2', 'timeFrame': '30 minutes during anesthesia, prior to separation from CPB', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (FCS) with Clauss Fibrinogen.'}, {'measure': 'Correlation Quantra vs TEG_Fibrinogen_Function2', 'timeFrame': '30 minutes during anesthesia, after coagulation products were given', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (FCS) with Clauss Fibrinogen.'}, {'measure': 'Correlation Quantra vs TEG_Platelet_Function', 'timeFrame': '30 minutes during anesthesia, prior to separation from CPB', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CS/PCS) with TEG (MA)'}, {'measure': 'Correlation Quantra vs TEG_Platelet_Function', 'timeFrame': '30 minutes during anesthesia, after coagulation products were given', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CS/PCS) with TEG (MA)'}, {'measure': 'Correlation Quantra vs TEG_clot initiation', 'timeFrame': '30 minutes during anesthesia, prior to separation from CPB', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CT/CTH) with TEG (R time)'}, {'measure': 'Correlation Quantra vs TEG_clot initiation', 'timeFrame': '30 minutes during anesthesia, after coagulation products were given', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CT/CTH) with TEG (R time)'}, {'measure': 'Correlation Quantra vs TEG_clot strength/firmness', 'timeFrame': '30 minutes during anesthesia, prior to separation from CPB', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CS) with TEG (G value)'}, {'measure': 'Correlation Quantra vs TEG_clot strength/firmness', 'timeFrame': '30 minutes during anesthesia, after coagulation products were given', 'description': 'Correlation/Linear regression/normal\\_vs\\_abnormal of Quantra (CS) with TEG (G value)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coagulopathy']}, 'referencesModule': {'references': [{'pmid': '40095320', 'type': 'RESULT', 'citation': 'Ochocinski D, Navaratnam M, Babb A, De Souza E, Kamra K, Sleasman JR, Margetson TD, Bhamidipati JK, Ramamoorthy C, Schmidt AR. Comparison of the Point-Of-Care Coagulation Device Quantra With the TEG-5000 for Congenital Cardiac Surgery-A Pilot Study. Paediatr Anaesth. 2025 Jun;35(6):469-480. doi: 10.1111/pan.15097. Epub 2025 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB.\n\nThe current testing device used at our institution is the "TEG 5000" (Haemonetics Corporation). The novel coagulation testing device "Quantra System" (Hemosonics) has favorable properties (result within 20 minutes) allowing for a quicker identification of the coagulation problem and hence faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products. The aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG 5000.', 'detailedDescription': 'Congenital heart surgery on cardio-pulmonary bypass (CPB) is associated with impacted coagulation quality and increased bleeding after separation of CPB. Therefore, coagulation products and blood products often need to be given/transfused during these cases. The correct choice and dosing of coagulation products is essential to effectively stop bleeding and reduce the need of additional blood transfusion.\n\nThe current testing device used at our institution during congenital heart surgery on CPB is the TEG 5000 (Haemonetics Corporation). Prior to separation from CPB (mostly 30-60 minutes) and after the first coagulation products were given (approx. 60 minutes after separation from CPB) a Clauss Fibrinogen and a TEG are drawn. These samples are sent to an off-site lab for processing and time to result ranges from 60-90 minutes. Therefore, results are often not present when needed.\n\nAn easy to use point-of-care (POC) test device being readily available in the operation room and allowing for rapid results could result in quicker identification of the coagulation problem and hence allow for faster administration of the correct coagulation products, potentially leading to better coagulation quality and possibly reducing the need of additional blood products.\n\nThe Quantra System (Hemosonics) is an easy-to-use, stand-alone device presenting results within 20 minutes. With these properties all above mentioned problems would be addressed. To date the Quantra has not been used and has not been evaluated in patients with congenital heart disease for cardiac surgery on CPB.\n\nThe aim of this prospective observational (non-interventional, investigational only) quality improvement study is to investigate if the Quantra is reliable and valid in predicting the coagulation status when compared with our standard-of-care device TEG\n\nAll patients who are enrolled in this study will be patients who are scheduled to undergo cardiac surgery and who require a general anesthesia, endotracheal intubation, arterial line placement and coagulation testing as part of standard of care for the surgery.\n\nNo patient will have a general anesthesia, endotracheal intubation, arterial line inserted or coagulation testing for research purposes only.\n\nIf the family/patient consent to be enrolled in the study the patient will be included in the study. It is standard of care to draw blood samples for coagulation testing (TEG and Clauss Fibrinogen) prior to separation of cardio-pulmonary-bypass (t1) and after the first coagulation products were given (t2), resulting in 2 x 5.4mL of blood.\n\nFor testing of efficacy/reliability/validity of the Quantra System we will need to draw additional blood samples (2.7mL) for each time point t1 and t2, resulting in a total of 2 x 2.7mL. These extra 5.4mL of blood drawn during the research portion of this study is additional to what they need for the surgical procedure and is not standard of care.\n\nNo clinical decision will be made on the results of the Quantra System. This is an investigational, non-interventional study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with congenital heart disease scheduled for cardiac surgery on cardio-pulmonary bypass at our institution Age range is 0 to 8 years. There are no enrollment restrictions related to gender or ethnic background.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All cases with hypothermia (\\<=30C)\n\nExclusion Criteria:\n\n* Neonatal/Infant Bloodless surgery\n* Bodyweight under 3kg'}, 'identificationModule': {'nctId': 'NCT05295693', 'briefTitle': 'Quantra vs TEG for Congenital Cardiac Surgery - a Pilot Validation Study', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparison of the Point-of-care Coagulation Device Quantra With the TEG for Congenital Cardiac Surgery - a Pilot Validation Study', 'orgStudyIdInfo': {'id': 'Quantra vs TEG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Correlation of the Quantra with the TEG', 'type': 'DEVICE', 'description': 'The purpose of this study is to evaluate the efficacy/reliability/validity of the Quantra device in patients with congenital heart disease for cardiac surgery on CPB.\n\nThe study if of investigational interest only. No clinical decisions will be made based on the results obtained by the Quantra device.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Alexander R Schmidt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}