[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06088758":3,"trial-entities:NCT06088758":181,"trial-summary:NCT06088758":185},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":131,"minimum_age":132,"maximum_age":133,"healthy_volunteers":134,"eligibility_criteria":135,"std_ages":148,"locations":151,"central_contacts":174,"overall_officials":178,"references":179,"see_also_links":180},"NCT06088758","2023P002561","Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool","RECRUITING","2027-07-31","2025-10","2025-11-03","2024-02-28","Massachusetts General Hospital","OTHER",true,"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.",null,[18],"Liver Transplant",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},200,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Normothermic machine perfusion (NMP) of steatotic liver","Steatotic liver grafts that are selected will be run on NMP to assess quality of graft and determine whether it meets criteria for transplantation",[33],"Liver Transplantation with Steatotic Liver",[35],{"measure":36,"description":37,"timeFrame":38},"Early allograft dysfunction","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\u002FL (to convert to microkatals per liter, multiply by 0.0167) within the first 7 postoperative days; bilirubin 10 mg\u002FdL 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","First week after transplant",[40,44,48,51,54,57,60,63,67,71,74,77,80,83,87,90,93,96,99,102,105,108,111,114,117,120,123,125,128],{"measure":41,"description":42,"timeFrame":43},"Intraoperative inotropic support","Number of participants in need of inotropic support to maintain hemodynamics intraoperatively after reperfusion of liver allograft","At reperfusion, 15 minutes, 1 hour, 2 hours, and 3 hours after reperfusion",{"measure":45,"description":46,"timeFrame":47},"Need for post-operative inotropic support","Number of participants in need of inotropic support upon admission to the ICU","First 30 days post-transplantation",{"measure":49,"description":50,"timeFrame":47},"Length of post-operative inotropic support","Length of inotropic support used after admission to the ICU, if needed",{"measure":52,"description":53,"timeFrame":47},"Need for post-operative mechanical ventilation","Number of participants in need of mechanical ventilation upon admission to ICU",{"measure":55,"description":56,"timeFrame":47},"Length of post-operative mechanical ventilation","Length of intubation after admission to ICU, if mechanical ventilation needed",{"measure":58,"description":59,"timeFrame":47},"ICU length of stay","Length of stay in ICU post-transplant",{"measure":61,"description":62,"timeFrame":47},"Renal replacement therapy requirement","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":64,"description":65,"timeFrame":66},"Peak AST and ALT","Concentration of peak AST and ALT","First 7 days post-transplantation",{"measure":68,"description":69,"timeFrame":70},"Internal Normalized Ratio (INR)","INR measurements for each participant until post-op day 7 or discharge","First 7 days post-transplantation or within first 30 days post-op if discharge is longer than 7 days out",{"measure":72,"description":73,"timeFrame":70},"Total bilirubin","Total bilirubin measurement (mg\u002Fdl) on post-op day 7 or day of discharge",{"measure":75,"description":76,"timeFrame":47},"30-day patient survival","30-day patient survival (percentage)",{"measure":78,"description":79,"timeFrame":47},"Re-listing for transplantation","Number of participants who require re-listing for liver transplantation within 30 days post-op",{"measure":81,"description":82,"timeFrame":47},"Adverse events","Incidence of any additional adverse events, not including 24-hour ICU stay post-transplant, post-transplant transfusion \\\u003C=6 units pRBCs, \\\u003C=2 units FFP, \\\u003C=2 units 6-pack of platelets, as these are considered routine",{"measure":84,"description":85,"timeFrame":86},"Biopsy-proven rejection episodes","Number of participants with biopsy-proven rejection episodes","Assessed at 3, 6, and 12 months post-transplant",{"measure":88,"description":89,"timeFrame":86},"Liver function tests more than 3 times normal","Number of participants with liver function tests more than 3 times normal; liver function tests (LFTs) will measure AST\u002FALT, bilirubin, INR",{"measure":91,"description":92,"timeFrame":86},"Additional procedures","Number of participants that require additional procedures beyond normal recovery standard of care post-liver transplant",{"measure":94,"description":95,"timeFrame":86},"Re-admissions","Number of participants with re-admissions after initial discharge",{"measure":97,"description":98,"timeFrame":86},"Ischemic cholangiopathy and anastomotic strictures by imaging","Number of participants with evidence of ischemic cholangiopathy and anastomotic strictures by imaging",{"measure":100,"description":101,"timeFrame":86},"Vascular complications by cross-sectional imaging or angiography","Number of participants with evidence of vascular complications by cross-sectional imaging or angiography",{"measure":103,"description":104,"timeFrame":86},"Presence of steatosis by imaging or histology","Number of participants with evidence of steatosis by imaging or histology",{"measure":106,"description":107,"timeFrame":86},"Degree of steatosis by imaging or histology","Degree of steatosis by imaging or histology, if present",{"measure":109,"description":110,"timeFrame":86},"Renal dysfunction","Presence of a decrease in GFR \\> 40 from pre-transplant baseline or creatinine \\>2 if received simultaneous liver-kidney transplant",{"measure":112,"description":113,"timeFrame":86},"Hyperlipidemia","Number of participants with evidence of hyperlipidemia",{"measure":115,"description":116,"timeFrame":86},"Immunosuppression medications","Types of immunosuppression medications required",{"measure":118,"description":119,"timeFrame":86},"Dosage of immunosuppression medications","Dosage of immunosuppression medications required in respective unit measurement (i.e. milligrams)",{"measure":121,"description":122,"timeFrame":86},"Drug levels of immunosuppression medications","Drug levels of immunosuppression medications present in blood titers drawn from participant in respective unit measurement (i.e. ng\u002FmL)",{"measure":78,"description":124,"timeFrame":86},"Number of participants who require re-listing for transplantation within 1 year post-op",{"measure":126,"description":127,"timeFrame":86},"Graft failure","Number of participants with evidence of graft failure",{"measure":129,"description":130,"timeFrame":86},"Patient death","Number of participants with evidence of patient death","ALL","18 Years","80 Years",false,{"inclusion":136,"exclusion":141,"raw_text":147},[137,138,139,140],"Age 18-80 years","Listed for liver transplantation at MGH","Calculated MELD-Na score \\\u003C= 25","Able to consent",[142,143,144,145,146],"Status 1a","Cardiac or pulmonary disease","Prior liver transplant","Requiring pressors at the time of liver offer","MELD\\\u003C15 and asymptomatic from liver disease","Inclusion Criteria:\n\n* Age 18-80 years\n* Listed for liver transplantation at MGH\n* Calculated MELD-Na score \\\u003C= 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\\\u003C15 and asymptomatic from liver disease",[149,150],"ADULT","OLDER_ADULT",[152],{"facility":153,"status":7,"city":154,"state":155,"zip":156,"country":157,"contacts":158,"geoPoint":171},"Massachusetts General Brigham","Boston","Massachusetts","02114","United States",[159,164,168],{"name":160,"role":161,"phone":162,"email":163},"Olivia Bourgeois, CRC II, BS","CONTACT","617-724-1976","obourgeois@mgb.org",{"name":165,"role":161,"phone":166,"email":167},"Emily Nyhan, CRC II, MS","617-643-6266","enyhan@mgb.org",{"name":169,"role":170},"Heidi Yeh, MD","PRINCIPAL_INVESTIGATOR",{"lat":172,"lon":173},42.35843,-71.05977,[175],{"name":169,"role":161,"phone":176,"email":177},"617-643-4533","hyeh@mgh.harvard.edu",[],[],[],{"nct_id":4,"conditions":182,"biomarkers":184},[183],"Liver Transplantation",[],{"nct_id":4,"found":14,"summary":186,"prompt_version":196},{"design":187,"status":188,"heading":189,"summary":190,"follow_up":191,"word_count":192,"commitments":193,"compensation":194,"drugs_mentioned":195},"This is an interventional study that plans to enroll 200 participants. It is a single-site study, meaning it will take place at one location.","completed","Normothermic Machine Perfusion for Liver Transplants","This study is looking at a new way to use donor livers that have some fat (steatotic livers). It uses a device called Normothermic Machine Perfusion (NMP) to improve the quality of these livers before transplant. The goal is to see if NMP can make more livers suitable for transplant, which would help more people needing a liver. You might be able to join if you are between 18 and 80 years old, are waiting for a liver transplant at MGH, and have a MELD-Na score of 25 or less. The study will consider NMP successful if the transplanted livers work well in the first week after surgery. The current status of this study is unclear.","The primary outcome, early allograft dysfunction, is measured at the first week after transplant.",116,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]