Sequential Hypo- and Normo-thermic Perfusion to Preserve Extended Criteria Donor Livers for Transplantation

NCT04023773 | Active Not Recruiting DMC FDA Device

• 1 other identifier: Sequential perfusion
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothermic machine perfusion (HMP) has been shown to be beneficial to preserve extended criteria donor (ECD) livers for transplantation. Normothermic machine perfusion (NMP) had the same benefits and also the convenience on liver quality assessment. The investigators proposed to do sequential HMP (1-4 hours) and NMP (1-14 hours) on 18 ECD transplanted human livers by using an institutional-developed perfusion device for liver transplantation.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (2)

• patient survival at 1 month post-transplant

  Patient survival will be recorded at 1 month post transplantation.

  1 month post-transplant

• graft survival at 1 month post-transplant

  graft survival will be recorded at 1 month post transplantation. The allograft will be considered lost if a patient has a primary non function (PNF), liver re-transplant or in the event of patient death.

  1 month post-transplant

Secondary Outcomes (10)

• rate of post-transplant early allograft dysfunction (EAD)

  in the first 7 days after transplantation

• patient survival at 6 month post-transplant

  6 month post-transplant

• graft survival at 6 month post-transplant

  6 month post-transplant

• Estimated blood loss at transplant surgery

  during surgery

• peak alanine aminotransferases in the first 7 days after transplantation

  in the first 7 days after transplantation

Study Arms (1)

Liver perfusion

EXPERIMENTAL

Device: Liver Machine Perfusion (MP) Device The liver grafts will be preserved at hypothermic and normothermic temperature on the institutional-developed Liver MP Device, and have continuous perfusion with oxygen supply in the ex vivo organ preservation phase.

Device: Liver Machine Perfusion (MP) device

Interventions

Liver Machine Perfusion (MP) device DEVICE

Donor livers will have ex vivo continuous perfusion on the institutional-developed Liver MP device. The temperature of liver grafts will be controlled during perfusion.

Liver perfusion

Eligibility Criteria

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

You may qualify if:

• Patients undergoing liver transplantation
• Age 18 or older at the time of transplantation
• Willingness and ability to comply with the study procedures
• Signed Informed Consent Form

You may not qualify if:

• Recipient of partial grafts (split and living donors)
• Mentally or legally incapacitated subjects
• Inability to understand the procedures due to language barriers
• Multiorgan transplant

Sponsors & Collaborators

• Koji Hashimoto: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Koji Hashimoto, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Physician

Model Details: Eighteen extended criteria donor livers will be transplanted after receiving sequential hypothermic and normothermic machine perfusion preservation prior to transplantation.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 18, 2019
• Study Start: May 1, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)