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OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation (PROTECT)

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ClinicalTrials.gov Identifier: NCT02522871
Recruitment Status : Active, not recruiting
First Posted : August 13, 2015
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.

Condition or disease Intervention/treatment Phase
Liver Transplantation Liver Preservation for Transplant Device: OCS™ Liver System Other: Control Not Applicable

Detailed Description:
The OCS™ Liver PROTECT Trial is a two-armed, multicenter, prospective, randomized, controlled pivotal trial to evaluate the effectiveness and safety of the OCS Liver to preserve and assess donor livers intended for transplantation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Randomized Trial to Evaluate The Effectiveness of The Portable Organ Care System (OCS™) Liver For Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)
Actual Study Start Date : February 3, 2016
Actual Primary Completion Date : October 22, 2019
Estimated Study Completion Date : October 15, 2021

Arm Intervention/treatment
Experimental: OCS Liver System
OCS Liver System
Device: OCS™ Liver System
Control
Standard of care (ice)
Other: Control



Primary Outcome Measures :
  1. Incidence of Early Liver Allograft Dysfunction (EAD) [ Time Frame: 7 days ]
    Incidence of early allograft dysfunction or primary non-function of donor liver

  2. Incidence of liver graft related Serious Adverse Events (SAEs) [ Time Frame: 30 days ]
    Examination of the frequency of liver graft-related serious adverse events (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Registered male or female primary Liver transplant candidate
  • Age ≥18 years old
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

  • Acute, fulminant liver failure
  • Prior solid organ or bone marrow transplant
  • Chronic use of hemodialysis or diagnosis of chronic renal failure, defined as chronic serum creatinine of >3 mg/dl for >2 weeks and/or requiring hemodialysis
  • Multi-organ transplant
  • Ventilator dependent
  • Dependent on > 1 IV inotrope to maintain hemodynamics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02522871


Locations
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Sponsors and Collaborators
TransMedics
Investigators
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Study Director: Ahmed Elbetanony, MD TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT02522871    
Other Study ID Numbers: OCS-LVR-092014
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: December 21, 2020
Last Verified: January 2020