NCT04186221

OCS Liver PROTECT Continued Access Protocol

Completed NA Results posted Last updated 24 July 2024

What this trial tests

NA trial testing OCS Liver System in Liver Transplant in 74 participants. Completed in 2 February 2023.

Timeline

3 February 2020

Primary endpoint
2 February 2021

2 February 2023

Quick facts

Lead sponsor	TransMedics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	74
Start date	3 February 2020
Primary completion	2 February 2021
Estimated completion	2 February 2023
Sites	17 locations across United States

Drugs / interventions tested

• OCS Liver System

Conditions studied

• Liver Transplant — all drugs for Liver Transplant →

Sponsor

TransMedics — full company profile →

Who can join

18 and older, any sex, with Liver Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants With Early Liver Allograft Dysfunction (EAD) Primary · 7 days

Participants with Early liver Allograft Dysfunction (EAD) or primary non-function, defined as presence of one or more of the following criteria: AST level \> 2000 IU/ml within the first 7 postoperative days; Bilirubin ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7; or Primary non-functioning graft within the first 7 days (defined as irreversible graft dysfunction requiring emergency liver re-transplantation or death, in the absence of immunologic or surgical causes)

Group	Value	95% CI
Treatment Arm	19

Patient Survival at Day 30 After Transplant Secondary · 30 days after transplant

Patient survival at day 30 post transplantation.

Group	Value	95% CI
Treatment Arm	73

Adverse events — posted to ClinicalTrials.gov

Time frame: Liver graft-related serious adverse events (LGRSAEs) were collected up to the 30-day follow-up after transplantation for the safety endpoint. All-cause mortality is reported through 30-days post transplant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 4/74 (5%)

Deaths: 1/74

Serious adverse events (2 terms)

Reaction	System	Treatment Arm
Hepatic artery thrombosis	Hepatobiliary disorders	—
Hepatic artery stenosis	Hepatobiliary disorders	—

Most-reported serious reactions: Hepatic artery thrombosis, Hepatic artery stenosis.

Data from ClinicalTrials.gov NCT04186221 adverse events section.

Sponsor's own description

Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.