Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT05045794
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058625', 'term': 'End Stage Liver Disease'}, {'id': 'D017093', 'term': 'Liver Failure'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'A centralized radiologist who evaluates imaging (MRCP) for one of the secondary endpoints (ischemic cholangiopathy) will be blinded to treatment assignment. The study is otherwise open label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, controlled, open-label, sequential assignment, non-inferiority design comparing two treatment arms (HOPE, static cold storage)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-11', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with early allograft dysfunction (EAD)', 'timeFrame': 'At Day 7 post-transplant'}], 'secondaryOutcomes': [{'measure': 'Model for early allograft function (MEAF) score', 'timeFrame': 'Within 3 days post-transplant', 'description': 'Based on definition by Olthoff et al, 2010 (doi: 10.1002/lt.22091)'}, {'measure': 'Proportion of patients with primary non-function (PNF)', 'timeFrame': 'Within 7 days post-transplant', 'description': 'Based on definition by Pareja et al, 2015 (doi: 10.1002/lt.23990)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Up to study participation ends at 1-year follow-up', 'description': 'Duration from initial ICU admission to hospital discharge order (measured in days)'}, {'measure': 'Length of intensive care unit stay', 'timeFrame': 'Up to study participation ends at 1-year follow-up', 'description': 'Duration from initial ICU admission to ICU discharge order (measured in days)'}, {'measure': 'Duration on dialysis', 'timeFrame': 'Up to study participation ends at 1-year follow-up', 'description': 'Duration from establishment of graft reperfusion until discontinuation of dialysis (measured in days)'}, {'measure': 'Donor liver utilization rate', 'timeFrame': 'Up to study participation ends at 1-year follow-up'}, {'measure': 'Patient survival rate', 'timeFrame': '30 days, 6 months, 1 year post-transplant'}, {'measure': 'Graft survival rate', 'timeFrame': '30 days, 6 months, 1 year post-transplant'}, {'measure': 'Incidence of adverse events (AEs)', 'timeFrame': '1 year post-transplant'}, {'measure': 'Incidence of serious AEs (SAEs)', 'timeFrame': '1 year post-transplant'}, {'measure': 'Incidence of unanticipated adverse device effects (UADEs)', 'timeFrame': '1 year post-transplant'}, {'measure': 'Incidence of ischemic cholangiopathy', 'timeFrame': '6 months, 1 year post-transplant'}, {'measure': 'Incidence of biopsy-proven liver rejection', 'timeFrame': '6 months, 1 year post-transplant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Hypothermic oxygenated machine perfusion', 'Liver preservation', 'Liver transplantation'], 'conditions': ['End Stage Liver DIsease', 'Liver Failure']}, 'referencesModule': {'references': [{'pmid': '37496117', 'type': 'DERIVED', 'citation': 'Kim SC, Foley DP. Strategies to Improve the Utilization and Function of DCD Livers. Transplantation. 2024 Mar 1;108(3):625-633. doi: 10.1097/TP.0000000000004739. Epub 2023 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver transplantation with ex-vivo liver preservation using static cold storage (SCS) followed by hypothermic oxygenated machine perfusion (HOPE) versus SCS only.', 'detailedDescription': 'Patients on the UNOS waiting list for liver transplantation who have been consented, meet study eligibility criteria and are matched to a liver allograft from donation after brain death (DBD) or donation after circulatory death (DCD) that meet the extended risk eligibility criteria will be randomized 1:1 to SCS followed by HOPE (HOPE arm) or to SCS only (SCS arm). The objective of the study is to demonstrate the safety and effectiveness of the VitaSmart Liver Machine by comparing endpoints between the HOPE and SCS arms.\n\nFollowing transplantation, patients will be monitored daily (labs, adverse events, medications/procedures) while inpatient, and then additionally on Days 14 and 30 and Months 3, 6 and 12. The primary efficacy endpoint of early allograft dysfunction (EAD) rate will be assessed between HOPE and control using a non-inferiority design. An interim analysis is planned after approximately 70% of patients have been completed primary endpoint data collection to assess for early study completion based on non-inferiority or superiority.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Donation after Brain Death (DBD) Liver Inclusion Criteria (one or more):\n\n* Donor age 50-85 years\n* Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)\n* Macrosteatosis 10-40%\n* Terminal ALT 250-1500 IU/ml\n* Peak ALT within 3 days 1000-3000 IU/ml\n* Terminal total bilirubin 2-4 mg/dl\n\nDonation after Brain Death (DBD) Liver Exclusion Criteria (one or more):\n\n* Donor age \\<18 or \\>85 years\n* Anticipated cold ischemia \\>15 hours\n* Macrosteatosis \\>40%\n* Terminal ALT \\>1500 IU/ml\n* Peak ALT within 3 days \\>3000 IU/ml\n* Terminal total bilirubin \\>4 mg/dl\n* Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject\n* Liver intended for split transplant\n* Liver from living donor\n* Donor terminal serum Na \\>160 mmol/L\n\nDonation after Cardio-circulatory Death (DCD) Liver Inclusion Criteria (all):\n\n* Donor age 18-60 years\n* Anticipated cold ischemia time \\<12 hours (excluding HOPE duration)\n* Functional warm ischemia time ≤35 minutes, defined as interval from the time of onset of donor hypotension (MAP \\<50mmHg) until the time of donor cross clamp\n* Macrosteatosis ≤20%\n* Terminal ALT ≤500 IU/ml\n* Peak ALT within 3 days ≤2000 IU/ml\n* Terminal total bilirubin ≤3 mg/dl\n\nDonation after Cardio-circulatory Death (DCD) Liver Exclusion Criteria (one or more):\n\n* Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of the Investigator, make the liver allograft unsuitable for transplant into the recipient subject\n* Liver intended for split transplant\n* Liver from living donor\n* Donor terminal serum Na \\>160 mmol/L\n\nRecipient Inclusion Criteria (one or more):\n\n* Subject (or legally authorized representative) is able to provide informed consent and HIPAA authorization\n* Subject is male or female and at least 18 years of age\n* Subject is registered as an active liver recipient on the UNOS waiting list for liver transplantation\n* Subject will undergo primary liver transplantation\n* Subject is willing to comply with the study requirements and procedures\n* Subject with hepatocellular carcinoma as indication for Orthotopic Liver Transplantation; the tumor must be within Milan Criteria or down-staged to Milan Criteria\n\nRecipient Exclusion Criteria (one or more):\n\n* Subject will undergo multiple organ transplantations (liver-kidney, liver-lung, etc.)\n* Subject is listed for liver transplantation due to fulminant liver failure (UNOS status 1A)\n* Subject is pregnant\n* Subject is on respiratory (ventilator dependent) and/or cardiocirculatory support (requires at least one intravenous inotrope to maintain hemodynamics)\n* Subject is enrolled in an interventional clinical trial with an investigational drug or device'}, 'identificationModule': {'nctId': 'NCT05045794', 'briefTitle': 'Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bridge to Life Ltd.'}, 'officialTitle': 'A Multicenter, Prospective, Open-label, Randomized Controlled Clinical Trial to Compare the Safety and Effectiveness of the VitaSmart Liver Machine Perfusion System With Static Cold Storage for Organ Preservation Prior to Liver Transplantation', 'orgStudyIdInfo': {'id': 'BTL-2020-01vs'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hypothermic oxygenated perfusion (HOPE)', 'description': 'Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine', 'interventionNames': ['Device: VitaSmart Liver Machine Perfusion System', 'Other: Static cold storage']}, {'type': 'OTHER', 'label': 'Static cold storage', 'description': 'Ex-vivo donor liver preservation using static cold storage only', 'interventionNames': ['Other: Static cold storage']}], 'interventions': [{'name': 'VitaSmart Liver Machine Perfusion System', 'type': 'DEVICE', 'otherNames': ['VitaSmart Liver Machine', 'Hypothermic oxygenated perfusion'], 'description': 'Following donor liver retrieval, preservation using static cold storage, and back table preparation in the transplant center operating room, the organ will be flushed with Belzer UW Machine Perfusion Solution (MPS) and perfused through the cannulated portal vein using cold, actively oxygenated MPS that is circulated at low pressure for 90 minutes to 5 hours. After disconnection from the device, donor liver implantation and reperfusion will proceed in accordance with institutional care standards.', 'armGroupLabels': ['Hypothermic oxygenated perfusion (HOPE)']}, {'name': 'Static cold storage', 'type': 'OTHER', 'description': 'Donor liver retrieval and preservation using standard of care cold storage methods', 'armGroupLabels': ['Hypothermic oxygenated perfusion (HOPE)', 'Static cold storage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92408', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01895', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Hospital and Medical Center', 'geoPoint': {'lat': 42.50482, 'lon': -71.19561}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David Reich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bridge to Life Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}