N/A
N=74
OCS Liver PROTECT Continued Access Protocol
Liver Transplant
Bottom Line
View on ClinicalTrials.gov: NCT04186221 ↗Enrolled (actual)
74
Serious AEs
5.4%
Results posted
Jul 2024
Primary outcome: Primary: Participants With Early Liver Allograft Dysfunction (EAD) — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- OCS Liver System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TransMedics
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Early Liver Allograft Dysfunction (EAD) |
19 | — |
| SECONDARY Patient Survival at Day 30 After Transplant |
73 | — |
Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Eligibility Criteria
Recipient Inclusion Criteria:
- Registered primary liver transplant candidate, male or female
- Age ≥ 18 years
- 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
Donor Inclusion Criteria
- Donor age ≥ 40 years, or
- Expected cross-clamp time ≥ 6 hours, or
- Donor after circulatory death (DCD) with age ≤ 55 years, or
- Steatotic liver > 0% and ≤ 40% macrosteatosis at time of retrieval
Donor Exclusion Criteria
- Living donors
- Liver intended for split transplants
- Positive serology (HIV, Hepatitis B surface antigen & Hepatitis C)
- Presence of moderate or severe traumatic liver injury, or anatomical liver abnormalities that would compromise ex-vivo perfusion of the donor liver (i.e., accessory blood vessels or other anatomy that require surgical repair) and livers with active bleeding (e.g., hematomas)
- Donor livers with macrosteatosis of > 40% based on retrieval biopsy readout.
Data sourced from ClinicalTrials.gov (NCT04186221). 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.