Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05074160
Other study ID # OCSLIVER-01-PAS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 14, 2021
Est. completion date June 2026

Study information

Verified date January 2024
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of the OLP Registry is to collect more data on the post-transplant clinical outcomes of DBD and DCD donor livers preserved and assessed on OCS Liver System according to the approved indication and the OCS device performance in the real-world setting.


Description:

OLP Registry is a multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 166
Est. completion date June 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult primary liver transplant recipients of DBD or DCD donor Livers perfused on OCS Liver System Donor Exclusion Criteria: - Donor livers with accessory arterial blood supply requiring back table anastomosis, major traumatic injury, or hematoma; or - Split donor liver; or - DCD donor liver with >30 minutes of warm ischemic time (defined as from withdrawal of life support until donor liver cold flush); or - DCD donors age >55 years; or - DCD donor liver with macrosteatosis of >15% - Living donors - Donors with positive serology for HIV, Hep B and C - Donors with macrosteatosis of =40% Recipient Exclusion Criteria: - Fulminant liver failure; or - Concurrent (multi-organ transplant) or previous solid organ or bone marrow transplant; or - Chronic renal dialysis at time of transplant; or - Dependency on more than 1 inotropic agent to maintain hemodynamics; or - Ventilator dependent at time of transplant.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OCS Liver
Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.

Locations

Country Name City State
United States Emory Atlanta Georgia
United States University of Alabama Birmingham Alabama
United States Massachusetts General Hospital Boston Massachusetts
United States Henry Ford Hospital Detroit Michigan
United States Duke Medical Center Durham North Carolina
United States Houston Methodist Houston Texas
United States University of California San Diego La Jolla California
United States University of Nebraska Medical Center Omaha Nebraska
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety Endpoint 6-months liver graft survival post-Liver transplant 6 months post-Liver transplant
Other Long Term Patient Survival K-M Patient survival at 1- and 2-years post-transplant 2 years post-transplant
Other Long Term Graft Survival K-M Graft survival at 6 months, 1- and 2-years post-transplant 2 years post-transplant
Primary Patient Survival 1-year patient survival with the originally transplanted liver (patient and graft survival) post-Liver transplant. 1 year post-Liver transplant
See also
  Status Clinical Trial Phase
Completed NCT02798861 - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed NCT03527238 - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine Phase 2
Completed NCT01696331 - Text Messaging for Adherence in Adolescent Liver Transplant Recipients N/A
Recruiting NCT05051605 - Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Recruiting NCT05940857 - Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry
Completed NCT01598987 - Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients. Phase 3
Completed NCT05087550 - Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Recruiting NCT04836923 - LIFT Intervention in Liver Transplant Candidates N/A
Not yet recruiting NCT03666689 - Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation
Not yet recruiting NCT06088758 - Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool N/A
Terminated NCT01230502 - Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation N/A
Completed NCT00171509 - Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients Phase 4
Not yet recruiting NCT06254248 - Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma Phase 2
Recruiting NCT06075745 - Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates Phase 2
Completed NCT02057484 - A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
Active, not recruiting NCT03577431 - Liver Transplantation With Tregs at MGH Phase 1/Phase 2
Recruiting NCT06342557 - Transitional ePRO Diary Liver
Not yet recruiting NCT04265157 - Hepato-duodenal Ligament Occlusion and Classic Technique in Liver Transplant
Recruiting NCT02863250 - Australian and New Zealand Massive Transfusion Registry
Completed NCT00698399 - Serum Markers of Ischemia Reperfusion Injury in Liver Transplant Patients N/A