RESTORE Declined Livers Study

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Results posted: Sep 23, 2026
    • Trial completed
    • Study completion date changed from estimate of Dec 31, 2025 to May 14, 2025
    • Eligibility criteria expanded, about 25 words
    • Secondary endpoints: details revised at 14 of 16 entries
    • Publications: details revised at 1 of 1 entry
  2. Secondary endpoints: details revised at 3 of 16 entriesv13
  3. Primary endpoints revised (2)
    • Secondary endpoints: 5 to 16
    v12
  4. Trial status: Active, Not Recruiting to Completedv11 Show 4 more changesShow less
    • Enrollment target: estimated 25 to confirmed 24
    • Study completion date changed from estimate of Dec 31, 2025 to May 14, 2025
    • Secondary endpoints revised (5)
    • Primary endpoints revised (2)
  5. Primary completion date: Sep 30, 2024 to May 14, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Sep 2026 to Dec 31, 2025
    • Site details revised
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary completion date changed from estimate of Sep 2024 to Sep 30, 2024
    • Site contact updated
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Primary completion date: Sep 2023 to Sep 2024
    • Study completion date: Sep 2023 to Sep 2026
    v7
  4. Primary completion date: Mar 2023 to Sep 2023
    • Eligibility criteria expanded, about 74 words
    v6
  5. Primary completion date: Mar 2022 to Mar 2023
    • Study completion date: Sep 2022 to Sep 2023
    v5
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2020 to Dec 3, 2020
    • Site details revised
    v4
  7. Phase: Phase 2 to Not applicable
    • Start date: Sep 2020 to Dec 2020
    v3
  8. Study title revisedv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.
Trial Details
NCT Number NCT04483102
Lead Sponsor Washington University School of Medicine
Collaborators: Mid-America Transplant, OrganOx Ltd.
Conditions
(from sponsor)		 Liver Diseases, Surgery, Transplant; Failure, Liver
Related terms Liver Diseases
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov