N/A
N=300
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
Liver Transplantation · Liver Preservation for Transplant
Bottom Line
View on ClinicalTrials.gov: NCT02522871 ↗Enrolled (actual)
300
Serious AEs
51.5%
Results posted
Jun 2023
Primary outcome: Primary: Participants With Early Liver Allograft Dysfunction (EAD) — 27; 44; 27; 47 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCS™ Liver System (Device); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Early Liver Allograft Dysfunction (EAD) |
27; 44; 27; 47 | <0.0001 sig |
| PRIMARY Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient |
0.046; 0.075 | <0.0001 sig |
| SECONDARY Patient Survival at Day 30 After Transplant |
150; 141; 151; 145 | 0.0004 sig |
| SECONDARY Patient Survival at Initial Hospital Discharge Post Liver Transplant |
149; 140; 150; 144 | 0.0006 sig |
Summary
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
Eligibility Criteria
Inclusion Criteria
- Registered male or female primary Liver transplant candidate
- Age ≥18 years old
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Exclusion Criteria
- Acute, fulminant liver failure
- Prior solid organ or bone marrow transplant
- Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl for >2 weeks and/or requiring hemodialysis
- Multi-organ transplant
- Ventilator dependent
- Dependent on > 1 IV inotrope to maintain hemodynamics
Data sourced from ClinicalTrials.gov (NCT02522871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.