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Machine Perfusion
Hypothermic Oxygenated Perfusion for Liver Transplant
N/A
Waitlist Available
Led By David Reich, MD
Research Sponsored by Bridge to Life Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)
Donor age 50-85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-transplant
Awards & highlights
Study Summary
This trial will compare outcomes of liver transplants using two different methods of ex-vivo preservation.
Who is the study for?
This trial is for patients needing a liver transplant, where the donor's age is between 50-85 years. The donor liver must have been preserved in cold conditions for 10-15 hours and show certain levels of fat, enzymes (ALT), and bilirubin. It excludes livers not from brain-dead donors.Check my eligibility
What is being tested?
The study compares two ways to preserve donated livers before transplantation: traditional cold storage versus using the VitaSmart Liver Machine Perfusion System followed by hypothermic oxygenated perfusion (HOPE).See study design
What are the potential side effects?
Potential side effects are related to how well the transplanted liver functions after surgery, which can include complications like poor organ function or rejection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My surgery involves a cold ischemia time of 10-15 hours, not counting HOPE duration.
Select...
I am between 50 and 85 years old.
Select...
My total bilirubin level is between 2-4 mg/dl.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with early allograft dysfunction (EAD)
Secondary outcome measures
Donor liver utilization rate
Duration on dialysis
Graft survival rate
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Static cold storageExperimental Treatment1 Intervention
Ex-vivo donor liver preservation using static cold storage only
Group II: Hypothermic oxygenated perfusion (HOPE)Experimental Treatment2 Interventions
Ex-vivo donor liver preservation using static cold storage followed by HOPE using the VitaSmart Liver Machine
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Who is running the clinical trial?
Bridge to Life Ltd.Lead Sponsor
David Reich, MDPrincipal InvestigatorDrexel University
3 Previous Clinical Trials
20,406 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My donor is between 18 and 85 years old.My liver transplant will be from a living donor.My surgery involves a cold ischemia time of 10-15 hours, not counting HOPE duration.I am between 50 and 85 years old.My total bilirubin level is between 2-4 mg/dl.My surgery is expected to have a delay over 15 hours before tissue analysis.My donated liver is considered unsuitable for transplant by the doctor.My liver transplant will involve splitting the liver for use in two patients.
Research Study Groups:
This trial has the following groups:- Group 1: Static cold storage
- Group 2: Hypothermic oxygenated perfusion (HOPE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited to take part in this research endeavor?
"Bridge to Life Ltd., the sponsor, will be conducting this clinical trial in multiple locations such as Ochsner Clinic Foundation and Nebraska Medical Center. They need a total of 244 eligible patients for it to commence."
Answered by AI
Is the enrollment for this trial still open?
"Affirmative. According to clinicaltrials.gov, this ongoing study is actively recruiting participants-- the trial was first posted on December 16th 2021 and last updated on September 20th 2022. The goal of the research is to enroll 244 patients across 15 different medical centres."
Answered by AI
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