Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT01001403
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2009-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Sponsor:
Organization:
Raw JSON
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From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nafamostat'}, {'id': 'FG001', 'title': 'Control'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nafamostat'}, {'id': 'BG001', 'title': 'Control'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '10', 'groupId': 'BG000'}, {'value': '52', 'spread': '11', 'groupId': 'BG001'}, {'value': '52', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-04', 'studyFirstSubmitDate': '2009-10-23', 'resultsFirstSubmitDate': '2010-03-21', 'studyFirstSubmitQcDate': '2009-10-23', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-04-08', 'studyFirstPostDateStruct': {'date': '2009-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)', 'timeFrame': 'during 5 min after reperfusion of liver graft', 'description': 'Before entering the study, we re-defined the criteria of PRS. From our clinical experiences, two types of PRS were observed according to its severity and treatment option. "Moderate" PRS was identical to previously defined PRS: more than 30% decrease of mean arterial pressure lasting over 1 min was observed within 5 min after reperfusion of the liver graft. However, we differentiated a "severe" form of PRS, in which MAP rapidly fell below 40 mmHg, from the moderate one, because severe PRS required prompt intervention to prevent a permanent damage of vital organs.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Postreperfusion Syndrome']}, 'descriptionModule': {'briefSummary': 'This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>= 18 year old scheduled to undergo liver transplantation\n\nExclusion Criteria:\n\n* Previous history of pulmonary, cardiovascular, or renal disease\n* Previous history of allergic reactions to nafamostat'}, 'identificationModule': {'nctId': 'NCT01001403', 'briefTitle': 'Effect of Nafamostat on Postreperfusion Syndrome (PRS)', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft', 'orgStudyIdInfo': {'id': 'CWJung_futhan-liver TPL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nafamostat', 'description': 'The Nafamostat mesilate group received 0.2 mg/kg of nafamostat mesilate intravenously 1 min before reperfusion of the liver graft.', 'interventionNames': ['Drug: Nafamostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group received 10 ml of normal saline (same volume as nafamostat)intravenously 1 min before reperfusion of the liver graft.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Nafamostat', 'type': 'DRUG', 'description': '0.2 mg/kg as bolus 1 minute before reperfusion', 'armGroupLabels': ['nafamostat']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '10 ml of normal saline', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chul Woo Jung', 'oldOrganization': 'Seoul National University Hospital'}}}}