Results of the initial phase of the portable organ care system (OCS™) liver protect pivotal trial.
Markmann J, Ghobrial M, Magliocca J, Demetris A, Abouljoud MS. Results of the initial phase of the portable organ care system (OCS™) liver protect pivotal trial.. Am J Transplant 2017; 17:305.
Am J Transplant
Purpose The OCS Liver PROTECT Trial is a prospective, international, randomized controlled trial to evaluate the impact of using portable ex-vivo warm, oxygenated blood perfusion using OCS Liver System on short and long-term clinical outcomes in liver transplantation as compared to standard cold ischemic storage. Methods OCS Liver PROTEC Trial compares preservation of donor livers using OCS-Liver perfusion system (OCS) to cold flush and storage (Control). A total of 300 liver transplant recipients will be randomized into the trial. Donor inclusion criteria: Age ≥40 years old; or total cross clamp time ≥6 hours; or DCD ≤55 years old; or ≤40% macrosteatosis. Donor exclusions: Living or split donors; or severe liver injury. Recipient inclusion criteria: age ≥ 18 years; registered male or female primary liver transplant candidate; signed written informed consent for the trial. Recipient exclusions: acute, fulminant liver failure; prior transplants; multi-organ transplant; ventilator dependence at time of transplantation. Short-Term primary endpoints are incidence of EAD within 7 days post-transplant, patient survival at day 30 and within initial hospital admission. Safety will be assessed by rate of liver graft related (LGR) SAEs within the initial 30 days post-transplant. Long-term endpoints: patient survival at 1 and 2 years. Results We are reporting the results of the initial 20 randomized patients in the PROTECT trial (OCS= 8 and Control= 12). Incidence of EAD was 1/8 patients (12.5%) in OCS vs 5/12 (41.7%) in Control. All patients survived to day 30. There was no LGR SAEs in the OCS vs 1 LGR SAE in Control. Liver biopsy assessment demonstrated lower IR injury markers and LSEC loss in the OCS arm compared to Control. Conclusion The initial experience with the OCS Liver in clinical transplantation demonstrated safety and encouraging early clinical outcomes. The trial is currently expanding enrollment.