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Organ Preservation Device

OCS Liver System for Liver Transplant (PROTECT Trial)

N/A
Waitlist Available
Research Sponsored by TransMedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Registered male or female primary Liver transplant candidate
Age ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post transplant
Awards & highlights

PROTECT Trial Summary

This trial will test how well the OCS Liver system preserves donor livers for transplantation.

Eligible Conditions
  • Liver Preservation
  • Liver Transplant

PROTECT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PROTECT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Participants With Early Liver Allograft Dysfunction (EAD)
Primary Safety Endpoint: Liver Graft-related Serious Adverse Events (LGRSAEs) up to 30-days Post-transplant Per Patient
Secondary outcome measures
Patient Survival at Day 30 After Transplant
Patient Survival at Initial Hospital Discharge Post Liver Transplant
Other outcome measures
Evidence of Ischemic Biliary Complications Diagnosed at 12 Months
Evidence of Ischemic Biliary Complications Diagnosed at 6 Months

PROTECT Trial Design

2Treatment groups
Experimental Treatment
Group I: OCS Liver SystemExperimental Treatment1 Intervention
OCS Liver System
Group II: ControlExperimental Treatment1 Intervention
Standard of care (ice)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OCS™ Liver System
2016
N/A
~300

Find a Location

Who is running the clinical trial?

TransMedicsLead Sponsor
22 Previous Clinical Trials
18,271 Total Patients Enrolled
Ahmed Elbetanony, MDStudy DirectorTransMedics
2 Previous Clinical Trials
83 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
2016. "OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02522871.
~33 spots leftby Apr 2025
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