Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 10:51 PM
Study NCT ID:
NCT01992757
Status:
COMPLETED
Last Update Posted:
2018-10-03
First Post:
2013-11-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thromboelastography-derived Functional Fibrinogen Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rupa.chowdary@uphs.upenn.edu', 'phone': '215-615-4105', 'title': 'Rupa Chowdary', 'organization': 'University of Pennsylvania Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cardiac Surgery With Cardiopulmary Bypass', 'description': 'patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FLEV Difference During Rewarming & Post-cardiopulmonary Bypass', 'description': 'All enrolled patients were in a single arm with multiple timepoints. FLEV values were obtained at baseline, rewarming, and post-CPB. The primary outcome was to compare the rewarming and post-CPB values to determine if a significant difference exists.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-25.8', 'upperLimit': '23.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in FLEV from rewarming and after cardiopulmonary bypass', 'description': 'FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '49 patients undergoing cardiac surgery with CPB.'}, {'type': 'SECONDARY', 'title': 'Difference in Clauss Assay and FLEV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Clauss vs FLEV at Rewarming and Post-CPB', 'description': 'All enrolled patients were in a single arm with multiple timepoints. Clauss assay and FLEV values were obtained at baseline, rewarming, and post-CPB. The secondary outcome was to compare the rewarming and post-CPB values of Clauss value to FLEV to determine if a significant difference exists.'}], 'classes': [{'title': 'Mean Clauss vs FLEV difference at rewarming', 'categories': [{'measurements': [{'value': '120.6', 'groupId': 'OG000', 'lowerLimit': '104.1', 'upperLimit': '137.1'}]}]}, {'title': 'Mean Clauss vs FLEV difference post-CPB', 'categories': [{'measurements': [{'value': '119.5', 'groupId': 'OG000', 'lowerLimit': '101.7', 'upperLimit': '137.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Clauss vs FLEV for rewarming and post-CPB', 'description': 'This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '49 patients undergoing cardiac surgery with CPB. The measure is the difference of the FLEV and the Clauss assay (i.e. FLEV minus Clauss since the FLEV is consistently higher).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cardiac Surgery With Cardiopulmary Bypass', 'description': 'Patients over the age of 18 years undergoing cardiac surgery requiring CPB. Patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': '2 patients excluded due to FFP given.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cardiac Surgery With Cardiopulmary Bypass', 'description': 'patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '84'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-02', 'studyFirstSubmitDate': '2013-11-05', 'resultsFirstSubmitDate': '2017-11-06', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-02', 'studyFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)', 'timeFrame': 'Change in FLEV from rewarming and after cardiopulmonary bypass', 'description': 'FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.'}], 'secondaryOutcomes': [{'measure': 'Difference in Clauss Assay and FLEV', 'timeFrame': 'Clauss vs FLEV for rewarming and post-CPB', 'description': 'This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['functional fibrinogen assay', 'cardiac surgery'], 'conditions': ['Focus of Study', 'Coagulation Status of Cardiac Surgery Patient', 'Reducing Excess Blood Transfusion']}, 'descriptionModule': {'briefSummary': 'This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cardiac surgery patients who are undergoing primary cardiac surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Re-operative cardiac surgery\n* History of hypercoagulable state as defined in medical record\n* Anticoagulated status at time of surgery\n* Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)'}, 'identificationModule': {'nctId': 'NCT01992757', 'acronym': 'TEG-FF', 'briefTitle': 'Thromboelastography-derived Functional Fibrinogen Levels', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': '818918'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac surgery with cardiopulmary bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Prakash A Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}