Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-26 @ 2:55 PM
Study NCT ID:
NCT05252559
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2022-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrafiltration on Coagulation Performance in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014462', 'term': 'Ultrafiltration'}], 'ancestors': [{'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-08', 'studyFirstSubmitDate': '2022-01-25', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximal clot firmness (MCF) of EXTEM assay', 'timeFrame': '30 minute after the completion of ultrafiltration', 'description': 'change of MCF-EXTEM assay'}], 'secondaryOutcomes': [{'measure': 'cut-off value of MCF-EXTEM to be improved by ultrafiltration', 'timeFrame': '30 minute after the completion of ultrafiltration', 'description': 'To estimate the cut-off value of MCF-EXTEM which can be increased by applying ultrafiltration'}, {'measure': 'maximal clot firmness (MCF) of EXTEM assay to be improved by ultrafiltration', 'timeFrame': '30 minute after the completion of ultrafiltration', 'description': 'change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM \\< the estimated cut-off value)'}, {'measure': 'maximal clot firmness (MCF) of EXTEM assay not to be improved by ultrafiltration', 'timeFrame': '30 minute after the completion of ultrafiltration', 'description': 'change of MCF-EXTEM by applying ultrafiltration in patients with reduced MCF-EXTEM before applying ultrafiltration (MCF-EXTEM \\> the estimated cut-off value)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrafiltration', 'cardiac valve disease', 'viscoelastic test', 'cardiopulmonary bypass'], 'conditions': ['Cardiac Valve Disease']}, 'descriptionModule': {'briefSummary': 'In cardiac surgery patients with CPB-induced dilutional coagulopathy, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components before the weaning from CPB. The impact of UF on the clot strength is determined by analyzing the changes of maximal clot formation in EXTEM assay (MCF-EXTEM) in the ROTEM test in patients who underwent elective cardiac valve surgery in KUMC.', 'detailedDescription': "In cardiac surgery patients, ultrafiltration (UF) was applied to reduce free water and concentrate all blood components during cardiopulmonary bypass (CPB). Concentrating plasma substrate of UF would be beneficial in attenuating CPB-induced dilutional coagulopathy. This study was to investigate whether MUF affected viscoelastic profiles during CPB for cardiac surgery.\n\nPatients who underwent elective cardiac surgery and MUF at the end of CPB during January 2019-December 2021 are recruited. Using the patients' electronic medical records, the values of maximum clot firmness of EXTEM assay (MCF-EXTEM) of rotational thromboelastometry (ROTEM) test before and after applying MUF are retrospectively analyzed.\n\nAs the primary measure, we determine the changes of MCF-EXTEM after applying MUF. With an assumption that MUF increased MCF-EXTEM, the receiver operating characteristic (ROC) analysis is applied to MCF-EXTEM change. The area under the ROC curve is determined and the cut-off value is estimated with specificity and sensitivity in Youden's J statistics. The change of MCF-EXTEM in patients who show MCF-EXTEM less than the cut-off value is analyzed. The changes of hematocrit (Hct) before and after applying MUF is also determined."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent elective cardiac valve surgery with moderate hypothermic CPB and ultrafiltration', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients underwent cardiac surgery during Jan 2019-Dec 2021\n* Patients underwent moderate hypothermic CPB\n* Patients underwent ultrafiltration during CPB\n* Patients underwent ROTEM tests (EXTEM assays and FIBTEM assay) before and after applying ultrafiltration\n\nExclusion Criteria:\n\n* Patients underwent packed RBC transfusion \\> 3 units during CPB\n* patients underwent ultrafiltration but the removed free water was \\< 250 ml\n* Patients underwent deep hypothermia'}, 'identificationModule': {'nctId': 'NCT05252559', 'briefTitle': 'Ultrafiltration on Coagulation Performance in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Effect of Modified Ultrafiltration on Whole Blood Coagulation in Cardiac Surgery With Cardiopulmonary Bypass: Retrospective Analysis', 'orgStudyIdInfo': {'id': '2019-05-008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrafiltration', 'type': 'PROCEDURE', 'description': 'In cardiac surgery patients, ultrafiltration is usually applied to reduce free water and concentrate all blood components before weaning from cardiopulmonary bypass'}, {'name': 'maximal clot firmness in EXTEM assay of ROTEM test', 'type': 'DIAGNOSTIC_TEST', 'description': 'before and after applying ultrafiltration, arterial blood sample underwent EXTEM and FIBTEM assays of rotational thromboelastometry'}]}, 'contactsLocationsModule': {'locations': [{'zip': '05030', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}