Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT06088758
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2023-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2023-09-22', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early allograft dysfunction', 'timeFrame': 'First week after transplant', 'description': 'Number of participants with initial poor function of liver allograft: measured by presence of 1 or more of the following: aspartate aminotransferase (AST) level higher than 2000 IU/L (to convert to microkatals per liter, multiply by 0.0167) within the first 7 postoperative days; bilirubin 10 mg/dL or higher (to convert to micromoles per liter, multiply by 17.104) on postoperative day 7; international normalized ratio (INR) of 1.6 or higher on postoperative day 7; or graft primary nonfunction within the first 7 days, defined as irreversible graft dysfunction leading to recipient death or emergency retransplant, in the absence of immunologic or surgical causes'}], 'secondaryOutcomes': [{'measure': 'Intraoperative inotropic support', 'timeFrame': 'At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion', 'description': 'Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft'}, {'measure': 'Need for post-operative inotropic support', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Number of participants in need of inotropic support upon admission to the ICU'}, {'measure': 'Length of post-operative inotropic support', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Length of inotropic support used after admission to the ICU, if needed'}, {'measure': 'Need for post-operative mechanical ventilation', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Number of participants in need of mechanical ventilation upon admission to ICU'}, {'measure': 'Length of post-operative mechanical ventilation', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Length of intubation after admission to ICU, if mechanical ventilation needed'}, {'measure': 'ICU length of stay', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Length of stay in ICU post-transplant'}, {'measure': 'Renal replacement therapy requirement', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Number of participants who require renal replacement therapy during the first 10 days after liver transplantation, if not on renal replacement prior to transplant'}, {'measure': 'Peak AST and ALT', 'timeFrame': 'First 7 days post-transplantation', 'description': 'Concentration of peak AST and ALT'}, {'measure': 'Internal Normalized Ratio (INR)', 'timeFrame': 'First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out', 'description': 'INR measurements for each participant until post-op day 7 or discharge'}, {'measure': 'Total bilirubin', 'timeFrame': 'First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out', 'description': 'Total bilirubin measurement (mg/dl) on post-op day 7 or day of discharge'}, {'measure': '30-day patient survival', 'timeFrame': 'First 30 days post-transplantation', 'description': '30-day patient survival (percentage)'}, {'measure': 'Re-listing for transplantation', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Number of participants who require re-listing for liver transplantation within 30 days post-op'}, {'measure': 'Adverse events', 'timeFrame': 'First 30 days post-transplantation', 'description': 'Incidence of any additional adverse events, not including 24-hour ICU stay post-transplant, post-transplant transfusion \\<=6 units pRBCs, \\<=2 units FFP, \\<=2 units 6-pack of platelets, as these are considered routine'}, {'measure': 'Biopsy-proven rejection episodes', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with biopsy-proven rejection episodes'}, {'measure': 'Liver function tests more than 3 times normal', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST/ALT, bilirubin, INR'}, {'measure': 'Additional procedures', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant'}, {'measure': 'Re-admissions', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with re-admissions after initial discharge'}, {'measure': 'Ischemic cholangiopathy and anastomotic strictures by imaging', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging'}, {'measure': 'Vascular complications by cross-sectional imaging or angiography', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of vascular complications by cross-sectional imaging or angiography'}, {'measure': 'Presence of steatosis by imaging or histology', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of steatosis by imaging or histology'}, {'measure': 'Degree of steatosis by imaging or histology', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Degree of steatosis by imaging or histology, if present'}, {'measure': 'Renal dysfunction', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Presence of a decrease in GFR \\> 40 from pre-transplant baseline or creatinine \\>2 if received simultaneous liver-kidney transplant'}, {'measure': 'Hyperlipidemia', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of hyperlipidemia'}, {'measure': 'Immunosuppression medications', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Types of immunosuppression medications required'}, {'measure': 'Dosage of immunosuppression medications', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)'}, {'measure': 'Drug levels of immunosuppression medications', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng/mL)'}, {'measure': 'Re-listing for transplantation', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants who require re-listing for transplantation within 1 year post-op'}, {'measure': 'Graft failure', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of graft failure'}, {'measure': 'Patient death', 'timeFrame': 'Assessed at 3, 6, and 12 months post-transplant', 'description': 'Number of participants with evidence of patient death'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Listed for liver transplantation at MGH\n* Calculated MELD-Na score \\<= 25\n* Able to consent\n\nExclusion Criteria:\n\n* Status 1a\n* Cardiac or pulmonary disease\n* Prior liver transplant\n* Requiring pressors at the time of liver offer\n* MELD\\<15 and asymptomatic from liver disease'}, 'identificationModule': {'nctId': 'NCT06088758', 'briefTitle': 'Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool', 'orgStudyIdInfo': {'id': '2023P002561'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Liver Transplantation with Steatotic Liver', 'description': 'Graft will be selected if 30-60% macrosteatosis and transplanted into liver transplant recipient with MELD of 15-25.', 'interventionNames': ['Device: Normothermic machine perfusion (NMP) of steatotic liver']}], 'interventions': [{'name': 'Normothermic machine perfusion (NMP) of steatotic liver', 'type': 'DEVICE', 'description': 'Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation', 'armGroupLabels': ['Liver Transplantation with Steatotic Liver']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olivia Bourgeois, CRC II, BS', 'role': 'CONTACT', 'email': 'obourgeois@mgb.org', 'phone': '617-724-1976'}, {'name': 'Emily Nyhan, CRC II, MS', 'role': 'CONTACT', 'email': 'enyhan@mgb.org', 'phone': '617-643-6266'}, {'name': 'Heidi Yeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Brigham', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Heidi Yeh, MD', 'role': 'CONTACT', 'email': 'hyeh@mgh.harvard.edu', 'phone': '617-643-4533'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Heidi Yeh', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}