WP02 Continued Access Study

Liver Transplantation Clinical Trial

Official title:

Continued Access Protocol Study for the Use of the OrganOx Metra Normothermic Machine Perfusion Device in Human Liver Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04862156
• Other study ID #: WP02
• Status: Terminated
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: July 7, 2023

Study information

• Verified date: January 2024
• Source: OrganOx Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The single-arm continued access phase will be used to collect additional effectiveness and safety data to support the objectives and outcomes of the original IDE pivotal study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: July 7, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is 18 years of age or greater
• Subject is registered as an active recipient on the UNOS waiting list for liver transplantation
• Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
• Subject is able and willing to comply with all study requirements

Exclusion Criteria:

• Subject requiring all of the following at the time of transplantation:

1. Oxygen therapy via a ventilator/respirator

2. Inotropic support

3. Renal replacement therapy

• Subject has acute/fulminant liver failure (UNOS status 1A)
• Subject undergoing simultaneous transplantation of more than one organ (e.g., liver and kidney)
• Subject is pregnant (as confirmed by urine or serum pregnancy test) or nursing
• Concurrent enrollment in another clinical trial. Subjects enrolled in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) are allowed to participate.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Device:
• Normothermic Machine Perfusion (NMP)
Storage and transportation of the donated liver using the OrganOx metra device.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Loyola University Chicago	Maywood	Illinois
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
OrganOx Ltd.	North American Science Associates Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Early Allograft Dysfunction (EAD)	Severity of immediate graft injury as measured by early allograft dysfunction (EAD).	7 days
Secondary	Incidence of Primary Non-function		10 days
Secondary	Measure Graft Survival		6 months
Secondary	Measure Subject Survival		6 months
Secondary	Measure Post-reperfusion Syndrome Via Mean Arterial Pressure (MAP)		1 day
Secondary	Measure Biochemical Liver Function Via Bilirubin (mg/dL)		6 months
Secondary	Measure Biochemical Liver Function Via GGT (IU/L)		6 months
Secondary	Measure Biochemical Liver Function Via ALT (IU/L)		6 months
Secondary	Measure Biochemical Liver Function Via AST (IU/L)		6 months
Secondary	Measure Biochemical Liver Function Via ALP (IU/L)		6 months
Secondary	Measure Biochemical Liver Function Via INR		6 months
Secondary	Measure Biochemical Liver Function Via Lactate (mmol/L)		6 months
Secondary	Incidence of Biliary Investigations/Interventions		6 months
Secondary	Measure Incidence of Livers Placed on the Device But Not Transplanted		1 day
Secondary	Measure Organ Utilization Via Incidence of EAD, Discard, or Primary Non-function		10 days
Secondary	Measure Healthcare Costs		6 months
Secondary	Measure Quality of Life Via the EQ-5D Quality of Life Index		6 months
Secondary	Incidence of Ischemia-reperfusion Injury Via Analysis of Post-reperfusion Biopsies		1 day