Ex Vivo End Ischemic Hypothermic Oxygenated Perfusion (hope) Versus Static Cold Storage Prior To Liver Transplantation – Preliminary Results Of The Bridge To Hope Pivotal Multicenter Randomized Controlled Clinical Trial On The Safety And Effectiveness Of The Vitasmart Liver Machine Perfusion System (clinicaltrials.gov: Nct05045794)
1Drexel University, Philadelphia, PA, 2Careggi U, Florence, Italy, 3Henry Ford, Detroit, MI, 4U Wisconsin, Madison, WI, 5Loma Linda, Loma Linda, CA, 6Washington U, Saint Louis, MO, 7UCSF, SF, CA, 8Methodist, Houston, TX, 9Cleveland Clinic, Cleveland, OH, 10Mount Sinai, NY, NY, 11U Nebraska, Omaha, NE, 12Mayo, Jacksonville, FL, 13Cleveland Clinic, Weston, FL, 14Lahey, Burlington, MA, 15Indiana U, Indianapolis, IN, 16Vanderbilt, Nashville, TN, 17Ochsner, New Orleans, LA
Meeting: 2022 American Transplant Congress
Abstract number: 9003
Keywords: Liver preservation, Liver transplantation, Machine preservation, Multicenter studies
Topic: Basic & Clinical Science » Basic & Clinical Science » 74 - Clinical Trials
Session Information
Session Name: Late Breaking: Clinical Trials
Session Type: Rapid Fire Oral Abstract
Date: Saturday, June 4, 2022
Session Time: 2:00pm-3:00pm
Presentation Time: 2:20pm-2:30pm
Location: Hynes Ballroom B
*Purpose: Ex vivo end ischemic hypothermic oxygenated machine perfusion (HOPE) is a simple technique to improve liver transplant (LT) results and the donor shortage. HOPE after static cold storage (SCS) reduces ischemia reperfusion injury, early allograft dysfunction (EAD), cholangiopathy, and other poor outcomes. A pivotal, multicenter RCT has opened to compare HOPE using the VitaSmart machine perfusion device with SCS alone for LT with higher risk DBD and DCD grafts.
*Methods: Consented adults matched to a higher risk DBD or DCD liver that the investigator has committed to transplant will be randomized 1:1 to SCS followed by HOPE at the transplant center, or to SCS only.
| DBD Inclusion Criteria (meets >1 criteria) | DBD Exclusion Criteria | DCD Criteria (meets all criteria) | |
| Donor Age | 50-85 | >85 | 18-60 |
| Anticipated CIT | 10-15 hr | >15 | <12 hr (& functional WIT <35 min) |
| Macrosteatosis | 10-40 % | >40 | <20 |
| Peak ALT | 1000-3000 IU | >3000 | <2000 |
| Terminal ALT | 250-1500 IU | >1500 | <500 |
| Terminal TB | 2-4 mg/dl | >4 | <3 |
HOPE with Belzer machine preservation solution will be portal venous (not arterial), 4-12°C, actively oxygenated (pO2>60 kPa), <4mmHg pressure, for 1.5-5 hr. The 10 endpoint is EAD; others are MEAF score, PNF, LOS, dialysis use, patient & graft survival, AEs, rejection, and cholangiopathy. A centralized, blinded radiologist will evaluate MRCPs. 244 subjects will be enrolled at ~15 US sites. Recipients will be assessed on postop days 1-7, 14 & 30, and at months 3, 6, & 12.
*Results: Initial enrollments were in early 2022. This report will be on 1) the study protocol; 2) virtual training & support to complement in-person interactions during Covid-19; 3) subject demographics; 4) experience with the RCT.
*Conclusions: This 1st US RCT of end ischemic HOPE with VitaSmart for LT of higher risk DCD and DBD grafts has started. Risk for selection bias is mitigated by randomizing after commitment to transplant an inspected liver. Another trial strength is systematic assessment for cholangiopathy by a central radiologist’s blinded review of MRCPs. End ischemic portal venous HOPE is a simple technique for improving higher risk liver graft use and LT outcomes.
To cite this abstract in AMA style:
Reich DJ, Schlegel A, Rizzari M, Foley D, DeVera M, Chapman W, Roll G, Saharia A, Quintini C, Florman S, Merani S, Mao S, Pinna A, Akoad M, Kubal C, Alexopoulos S, Bohorquez H. Ex Vivo End Ischemic Hypothermic Oxygenated Perfusion (hope) Versus Static Cold Storage Prior To Liver Transplantation – Preliminary Results Of The Bridge To Hope Pivotal Multicenter Randomized Controlled Clinical Trial On The Safety And Effectiveness Of The Vitasmart Liver Machine Perfusion System (clinicaltrials.gov: Nct05045794) [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/ex-vivo-end-ischemic-hypothermic-oxygenated-perfusion-hope-versus-static-cold-storage-prior-to-liver-transplantation-preliminary-results-of-the-bridge-to-hope-pivotal-multicenter-randomized-contro/. Accessed December 3, 2024.« Back to 2022 American Transplant Congress