Trial Outcomes & Findings for OCS Liver PROTECT Continued Access Protocol (NCT NCT04186221)

NCT ID: NCT04186221

Last Updated: 2024-07-24

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2024-07-24

Participant Flow

Participant milestones

Measure	Treatment Arm OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Overall Study STARTED	74
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment Arm OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Overall Study Death	1

Baseline Characteristics

OCS Liver PROTECT Continued Access Protocol

Baseline characteristics by cohort

Measure	Treatment Arm n=74 Participants OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Age, Continuous	57.01 Years STANDARD_DEVIATION 11.572 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Treatment Arm n=74 Participants OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Participants With Early Liver Allograft Dysfunction (EAD)	19 Participants

SECONDARY outcome

Timeframe: 30 days after transplant

Patient survival at day 30 post transplantation.

Outcome measures

Measure	Treatment Arm n=74 Participants OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Patient Survival at Day 30 After Transplant	73 Participants

Adverse Events

Treatment Arm

Serious events: 4 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Treatment Arm n=74 participants at risk OCS Liver System: OCS Liver System for preserving and assessing donor livers for transplantation
Hepatobiliary disorders Hepatic artery thrombosis	4.1% 3/74 • Number of events 3 • 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. Only death and serious adverse events were assessed. Other (Not Including Serious) Adverse Events were not monitored/assessed, and therefore are not reported.
Hepatobiliary disorders Hepatic artery stenosis	1.4% 1/74 • Number of events 1 • 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. Only death and serious adverse events were assessed. Other (Not Including Serious) Adverse Events were not monitored/assessed, and therefore are not reported.

Other adverse events

Adverse event data not reported

Additional Information

Laura Damme, VP Clinical Affairs

TransMedics, Inc.

Phone: 978-552-0900

Email: ldamme@transmedics.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sites shall have right to publish results. To balance this right with TransMedics' (TM) proprietary interests, site will submit manuscripts intended for publication for TM review at least 30 days prior to submission date. TM will complete its review within 30 days of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request.
• Publication restrictions are in place

Restriction type: OTHER