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NCT04186221 · ClinicalTrials.gov registry record · NA
OCS Liver PROTECT Continued Access Protocol
A NA study of Liver Transplant, sponsored by TransMedics.
- Completed
- Registry status
- NA
- Development phase
- 74
- Enrollment target
- 17
- Study locations
NCT04186221: Completed NA study of Liver Transplant, sponsored by TransMedics.
NCT04186221 is a NA study of Liver Transplant that has completed, run by TransMedics. The registered enrollment target is 74 participants, below the 5,454-participant average among 19 other Liver Transplant trials with a reported enrollment target (99% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04186221, a NA study of Liver Transplant, has completed, sponsored by TransMedics.
- COMPLETED
- Registry status
- NA
- Development phase
- 74 participants
- Enrollment target
- 17
- Study locations
Study Summary
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
Primary Outcome
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)
Conditions Studied
Interventions
- DEVICE OCS Liver System
Study Locations (17)
California
- Scripps - La Jolla
- University of California San Diego - La Jolla
- UCSF - San Francisco
Texas
- University of Texas Southwest - Dallas
- Houston Methodist Hospital - Houston
- The University of Texas Health Science Center at San Antonio - San Antonio
New York
- Mount Sinai Hospital - New York
- Montefiore Einstein Center for Transplantation - The Bronx
Virginia
- University of Virginia - Charlottesville
- Virginia Commonwealth University Health System - Richmond
Florida
- Tampa General - Tampa
Maryland
- Johns Hopkins - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2023-02-02 |
| Phase | NA |
What the finished NCT04186221 record still lists
NCT04186221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 5,454-participant average among 19 other Liver Transplant trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Liver Transplant appearing as the primary indexed condition, and to 1 intervention - of which OCS Liver System is the first listed.
NCT04186221 lists 17 locations in 11 states (California, Texas, New York).
Frequently Asked Questions
What is clinical trial NCT04186221 about?
NCT04186221 is a clinical study titled "OCS Liver PROTECT Continued Access Protocol". Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
What is the current status of trial NCT04186221?
This trial is currently completed. It is a NA study. The enrollment target is 74 participants. The study started on 2020-02-03. Estimated completion is 2023-02-02.
What conditions does trial NCT04186221 study?
This clinical trial studies the following conditions: Liver Transplant.
What interventions are being tested in trial NCT04186221?
The interventions under investigation include: OCS Liver System (DEVICE).
Who is sponsoring clinical trial NCT04186221?
This trial is sponsored by TransMedics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04186221 being conducted?
This trial has 17 study locations across California, Florida, Maryland, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Liver Transplant
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04186221's enrollment target sits among peer trials
74 10th of 19 higher than 9 of 19 other Liver Transplant trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Transplant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
RECRUITING · NA
-
Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool
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Text Messaging for Adherence in Adolescent Liver Transplant Recipients
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Increasing Activity in Liver Transplant Patients
COMPLETED · NA
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Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
RECRUITING · Phase 2
-
US National OCS Liver Perfusion (OLP) Registry
RECRUITING
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