Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT01274520
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2010-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hypothermic Machine Preservation-Phase 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jjg46@cumc.columbia.edu', 'phone': '(212)305.3839', 'title': 'James V. Guarrera, MD, FACS', 'organization': 'Columbia University College of Physicians and Surgeons - Center for Liver Disease and Transplantation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': "Serious Adverse Event (SAE) is defined as any clinically significant event which required a hospitalization admission during the subject's participation in the trial. Only SAEs were reported for the purposes of data collection and data analysis in this study.", 'eventGroups': [{'id': 'EG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository.", 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 6, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Events Requiring Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Serious'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Survival at One Year Post-Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended donor criteria (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Graft Survival at One Year Post-Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Analysis was based on the amount of liver allografts in each cohort that were deemed to be clinically functional at 1 year post-transplantation (i.e. no re-transplantation required).', 'unitOfMeasure': 'grafts', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Primary Graft Nonfunction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 7', 'description': 'Incidence of Primary Graft Nonfunction (PNF), defined as follows:\n\n* Relisted for orthotopic liver transplantation (OLT) within 7 days of OLT, not for vascular thromboses\n* Alanine aminotransferase (ALT) \\>2000 and one or both of: acidosis with pH \\<7.3 or lactate \\>2X (two times) normal\n* International normalized ratio (INR) \\>2.5', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Early Allograft Dysfunction (EAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the first 7 days post-transplantation', 'description': 'Incidence of Early Allograft Dysfunction (EAD), defined as follows:\n\n* Bilirubin \\>10 on post-operative day (POD)#7\n* International normalized ratio (INR) \\>1.6 on POD#7\n* Transaminase level (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) \\>2000 within the first 7 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Post-Operative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'title': 'Retransplant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HAT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 Month Post-Transplantation', 'description': 'Incidence of Retransplants or Hepatic Artery Thrombosis (HAT) within 1 month post-transplantation', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Bile Leaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of bile leaks.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Re-Operation For Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of patients who required re-operation for a bleeding event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Hernia Events Within 1 Year Post-Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'unitOfMeasure': 'hernia events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay (Index Transplant Hospitalization)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '52'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '51'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'First admission after transplant', 'description': 'Length of transplant hospital stay post-transplantation (Index Transplant Hospitalization)', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time With Stent (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended criteria donor (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model for End-Stage Liver Disease (MELD) score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '365'}, {'value': '66.5', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Measure of biliary complications as evidenced by mean time with stent (in days).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Biliary Strictures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of biliary strictures.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Endoscopic Retrograde Cholangiopancreatographies (ERCPs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'OG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of endoscopic retrograde cholangiopancreatographies (ERCPs)', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored ECD grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'FG001', 'title': 'Experimental: Medtronic Portable Bypass System Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '24 liver recipients who received extended criteria donor (ECD) liver transplant allografts were recruited for our treatment group over a span of 2 years. As a high-volume, major NY transplant center with approximately 270 adult patients on our Liver Transplant Waiting List and 45-50% receiving ECD grafts, we were able to meet our enrollment goal.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Matched Control Group', 'description': "This study had a matched cohort design. Treatment subjects were matched with 25 historical control patients who received similar cold stored extended criteria donor (ECD) grafts. Subjects were matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model for End-Stage Liver Disease (MELD) score and disease etiology. Additional analyses were performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}, {'id': 'BG001', 'title': 'Experimental: Hypothermic Machine Perfusion Group Group', 'description': '24 subjects were treated with the Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole, and the BioCal® blood temperature control module was used for machine perfusion of liver grafts. These products are commercially available and are used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-21 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '22-29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Racial Category (Single category per participant)', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Experimental group: Adult recipients of ECD deceased donor liver grafts (organ must have been declined by ≥1 transplant center) who were non-critically ill (not in intensive care, MELD \\< 35) at time of transplant.\n\nHistorical control group: Patients who received liver grafts with similar donor characteristics and standard cold storage preservation.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2010-11-03', 'resultsFirstSubmitDate': '2015-05-14', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-24', 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Survival at One Year Post-Transplantation', 'timeFrame': 'Post-Operative Day 1 to Day 365'}, {'measure': 'Graft Survival at One Year Post-Transplantation', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Analysis was based on the amount of liver allografts in each cohort that were deemed to be clinically functional at 1 year post-transplantation (i.e. no re-transplantation required).'}], 'secondaryOutcomes': [{'measure': 'Incidence of Primary Graft Nonfunction', 'timeFrame': 'Post-Operative Day 1 to Day 7', 'description': 'Incidence of Primary Graft Nonfunction (PNF), defined as follows:\n\n* Relisted for orthotopic liver transplantation (OLT) within 7 days of OLT, not for vascular thromboses\n* Alanine aminotransferase (ALT) \\>2000 and one or both of: acidosis with pH \\<7.3 or lactate \\>2X (two times) normal\n* International normalized ratio (INR) \\>2.5'}, {'measure': 'Incidence of Early Allograft Dysfunction (EAD)', 'timeFrame': 'Within the first 7 days post-transplantation', 'description': 'Incidence of Early Allograft Dysfunction (EAD), defined as follows:\n\n* Bilirubin \\>10 on post-operative day (POD)#7\n* International normalized ratio (INR) \\>1.6 on POD#7\n* Transaminase level (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) \\>2000 within the first 7 days'}, {'measure': 'Incidence of Post-Operative Complications', 'timeFrame': '1 Month Post-Transplantation', 'description': 'Incidence of Retransplants or Hepatic Artery Thrombosis (HAT) within 1 month post-transplantation'}, {'measure': 'Incidence of Bile Leaks', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of bile leaks.'}, {'measure': 'Incidence of Re-Operation For Bleeding', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of patients who required re-operation for a bleeding event'}, {'measure': 'Incidence of Hernia Events Within 1 Year Post-Transplantation', 'timeFrame': 'Post-Operative Day 1 to Day 365'}, {'measure': 'Hospital Length of Stay (Index Transplant Hospitalization)', 'timeFrame': 'First admission after transplant', 'description': 'Length of transplant hospital stay post-transplantation (Index Transplant Hospitalization)'}, {'measure': 'Time With Stent (Days)', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Measure of biliary complications as evidenced by mean time with stent (in days).'}, {'measure': 'Incidence of Biliary Strictures', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of biliary strictures.'}, {'measure': 'Incidence of Endoscopic Retrograde Cholangiopancreatographies (ERCPs)', 'timeFrame': 'Post-Operative Day 1 to Day 365', 'description': 'Incidence of endoscopic retrograde cholangiopancreatographies (ERCPs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['ECD liver transplant allografts', 'Hypothermic machine perfusion', 'Cold storage preservation', 'liver transplant', 'portable bypass system', 'machine perfusion preservation', 'extended criteria liver'], 'conditions': ['Liver Damage']}, 'referencesModule': {'references': [{'pmid': '25521639', 'type': 'DERIVED', 'citation': 'Guarrera JV, Henry SD, Samstein B, Reznik E, Musat C, Lukose TI, Ratner LE, Brown RS Jr, Kato T, Emond JC. Hypothermic machine preservation facilitates successful transplantation of "orphan" extended criteria donor livers. Am J Transplant. 2015 Jan;15(1):161-9. doi: 10.1111/ajt.12958. Epub 2014 Dec 17.'}]}, 'descriptionModule': {'briefSummary': "This is a study comparing a technique of continuous circulation to the liver as a means of preventing liver damage during transportation to the transplant hospital. This new technique of Machine Perfusion (MP) will be compared to the standard technique where the liver is maintained in a bag of solution on ice without circulation. The investigators will evaluate and compare the outcomes of the transplants with the new technique to the standard technique. There will be 24 MP patient's in the study. The investigators have previously used this technique with success in 20 human liver transplant patients. The investigators think there will be a benefit in terms of less damage to and better function of the donor liver which will result in faster recovery for the patients. This protective effect may allow us to successfully transplant more patients and prevent people from dying while waiting for a liver transplant.", 'detailedDescription': 'It is our hypothesis that liver machine perfusion will increase the safe utilization of the existing supply of extended criteria donor (ECD) livers by (1) increasing the quality and duration of preservation thereby reducing the clinical effects reperfusion injury (2) improving early outcomes in patients receiving ECD liver allografts (3) developing reliable markers for pretransplant assessment of the potential graft (4) giving surgeons more confidence when transplanting ECD livers and (5) allowing an avenue for ex vivo manipulation of the liver to protect or restore a transiently injured liver.\n\nThe proposed study is a matched cohort design. Potential subjects will be recruited from the Center for Liver Disease and Transplantation (CLDT) active Liver Transplant Waiting List. The Principal Investigator as well as the CoInvestigators, are all actively involved in the pre transplant evaluation process. Patients who are on the Waiting List and have provided written consent to receive an ECD graft will be recruited for this trial. Subjects will be matched with 24 historical control patients who received similar cold stored ECD grafts. Subjects will be matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, Model End-Stage Liver Disease (MELD) score and disease etiology.\n\nSubjects will be noncritically ill, not in an intensive care unit, and have a MELD \\< 35 in order to minimize the variability in outcome in the sickest patients. All subjects must provide written informed consent and meet the inclusion and exclusion criteria.\n\nSubjects will be followed for one year post transplantation, in conjunction with their routine liver transplant followup appointments. Retention of subjects for this trial will not be a challenge, in that the followup visit time points (postoperative days 1 through the discharge date, 7, 14, 30, 90, 180 and 365) are all consistent with our standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed written informed IRB consent by patient or patient's legally appointed representative.\n* Be at least 18 years of age; male or female.\n* Listed with UNOS for liver transplantation.\n* Organ declined by at least one transplant center\n* Extended criteria donor as defined by:\n\n * Presence of hepatitis C antibody\n * Donation after Cardiac Death (DCD)\n * Severe Hypernatremia: donor serum sodium \\>165 meq/L for at least 12 hours prior to procurement\n * Donor age ≥65 years\n * Presence of significant steatosis \\>25% macrovesicular by biopsy\n * Evidence of significant donor ischemic injury\n * Current donor serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>1000 IU/L\n * Ischemic injury evidenced by prolonged hypotension, high pressor requirement and/or rising serum liver function tests or one test more than five times the upper limit of normal (AST, ALT, or Total Bilirubin)\n\nExclusion Criteria:\n\n* Patients in whom the donor liver will be subjected to less than 4 hours of cold ischemia (surgeon desires immediate implantation)\n* Patient hospitalized in intensive care unit (ICU) at time of transplantation and/or physiologic MELD score \\>35\n* Dual organ recipient\n* ABO incompatibility\n* Retransplantation"}, 'identificationModule': {'nctId': 'NCT01274520', 'acronym': 'HMP2', 'briefTitle': 'Hypothermic Machine Preservation-Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation', 'orgStudyIdInfo': {'id': 'AAAD6236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Hypothermic Machine Perfusion Group', 'description': 'The Medtronic Portable Bypass System (PBS®) with Model 550 Bioconsole and the BioCal® blood temperature control module will be used for machine perfusion of liver grafts. These products are commercially available and used in clinical practice for cardiopulmonary bypass and extracorporeal membrane oxygenation. The Medtronic system utilizes an atraumatic centrifugal pump that can deliver the flow rates approximating portal venous flow in human livers, and it has modules for online membrane oxygenation, and electronic flow measurement.', 'interventionNames': ['Device: The Medtronic Portable Bypass System (PBS®)']}, {'type': 'NO_INTERVENTION', 'label': 'Matched control group', 'description': "The proposed study is a matched cohort design. Subjects will be matched with 24 historical control patients who received similar cold stored ECD grafts. Subjects will be matched on known covariates including donor age, donation after cardiac death, steatosis, both warm and cold ischemia times, recipient age, MELD score and disease etiology. Additional analyses will be performed on historical control blood and/or tissue samples previously collected and stored in the study's sample repository."}], 'interventions': [{'name': 'The Medtronic Portable Bypass System (PBS®)', 'type': 'DEVICE', 'otherNames': ['Medtronic Portable Bypass System (PBS®)'], 'description': 'Will be used for machine perfusion of liver grafts.', 'armGroupLabels': ['Experimental: Hypothermic Machine Perfusion Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'James V Guarrera, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}