June’s Article of the Month, with commentary from Dr. Scott Byram, examines the OCS Liver PROTECT trial — the first multicenter randomized clinical trial comparing portable normothermic machine perfusion (NMP) to standard ischemic cold storage (ICS) for liver preservation. Across 20 U.S. transplant programs and 293 recipients, NMP using the Organ Care System reduced early allograft dysfunction, lowered ischemic biliary complications at 6 and 12 months, and enabled greater use of marginal donor organs — particularly DCD livers.
Key Findings
- Trial design: Multicenter RCT (2016–2019), 20 U.S. centers, 293 per-protocol recipients (151 OCS / 142 ICS) — donors enriched for risk factors (DBD > 40, DCD, macrosteatosis, prolonged ischemia)
- Primary endpoint met: Early allograft dysfunction reduced from 31% (ICS) to 18% (OCS); p = .01
- Ischemic biliary complications: Significantly lower with OCS at 6 months (1.3% vs. 8.5%; p = .02) and 12 months (2.6% vs. 9.9%; p = .02)
- Donor pool expansion: OCS enabled use of DCD livers in 51% vs. 26% with ICS (p = .007); twice as many organs were discarded during procurement in the ICS group on “clinical judgment”
- Histopathology: Reduced moderate-to-severe lobular inflammation after reperfusion (6% OCS vs. 13% ICS; p = .004), consistent with less ischemia-reperfusion injury
- Mean perfusion time: 276 minutes on the OCS device
