Normothermic Liver Preservation Trial

NCT03089840 | Completed Phase 1 DMC

• 1 other identifier: Pro00043239
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is to assess the safety and efficacy of normothermic machine perfusion (NMP) as an organ preservation method prior to transplantation using the OrganOx metra™ device.

Conditions

End Stage Liver Disease; Liver Diseases

Keywords

normothermic perfusion; liver transplantation

Outcome Measures

Primary Outcomes (1)

• Graft survival rate

  Graft survival rate

  Day 30

Secondary Outcomes (8)

• Patient survival rate

  Day 30

• Early Allograft Dysfunction (EAD) rate

  Up to Day 7

• Peak aspartate transaminase (AST) levels

  Up to Day 7

• Daily lactate levels

  Up to Day 7

• Perfusate AST levels

  Day -1 and Day 0

Study Arms (1)

Normothermic Machine Perfusion (OrganOx metra)

EXPERIMENTAL

Donor livers will be placed on the OrganOx metra device for normothermic perfusion before transplantation.

Device: OrganOx metra

Interventions

OrganOx metra DEVICE

Following the routine retrieval procedure at the donor hospital the liver will be flushed with cold preservation solution and prepared for cannulation. The donor organ is then placed on the OrganOx metra device and will be perfused with warmed solution. The OrganOx metra device containing the donor organ is then transported to the recipient transplant centre. The donor liver is then removed from the device and flushed with standard of care preservation solution. Alternatively, where more practical, the livers will be transported to the University of Alberta hospital with ≤ 6 hours of cold storage and then placed on the metra™ for ≥ 4 hours. Implantation and reperfusion of the liver proceed as per the usual practice of the recipient transplant centre.

Normothermic Machine Perfusion (OrganOx metra)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (age ≥18 years); active on the waiting list for liver transplantation at the University of Alberta Hospital; informed/deferred consent provided.
• Whole livers from deceased donors ≥ 40kg in weight, that are deemed suitable for transplantation as per local and international practice, and at the discretion of the transplanting surgeon.
• Donor livers will be placed on the metra™ device either at the donor hospital, or where more practical, transported to the University of Alberta hospital with ≤ 6 hours of cold storage and then reperfused on metra™ for ≥ 4 hours ('back-to-base' sub-analysis).
• Expanded criteria grafts may include, but not be restricted to the following graft qualities. Such grafts will only be transplanted at the recipient transplant surgeon's discretion, if judged to be safe and appropriate for that individual recipient.
• Donation after Neurological Determination of Death (NDD) Expanded Criteria livers may include: ≥60% macro/micro steatosis; cold ischemia \> 10 hours; combined steatosis 30-60% and \>6hr cold storage; significant liver trauma.
• Donation after Cardio-Circulatory Death (DCD) Expanded Criteria livers may include: Age up to 75; mild steatosis (30%); DCD offers from distant centres; warm time up to 60 min.
• As per standard clinical practice, the on-call recipient transplant surgeon will evaluate donor and graft information, weigh the risks and benefits of graft utilization for a particular recipient, and make the final decision about whether or not to proceed to transplantation. Based on preliminary experience with the metraTM, perfusion parameters may additionally be considered in reaching a decision:
• Normal, stable portal vein flow (≥800-1000ml/minute) and artery flow (≥200ml/minute)
• Falling lactate levels
• Stable perfusate pH within the normal range (7.2 - 7.4) after bicarbonate correction
• Evenly perfused graft on the device

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2C8, Canada

Location

MeSH Terms

Conditions

End Stage Liver Disease; Liver Diseases

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Digestive System Diseases

Study Officials

• James Shapiro, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized, open-label, single arm, prospective trial using retrospective matched controls

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: March 24, 2017
• Study Start: February 24, 2017
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Locations

CA (1)