Live Donor Champion Program for Liver Disease

(LLDC Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Age less than 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

76 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Liver Live Donor Champion Program for liver disease?

Research shows that living donor liver transplantation (LDLT) can reduce waitlist mortality and provide excellent long-term outcomes for patients with end-stage liver disease. Advances in surgical techniques and immunosuppressive drugs have improved the success rates of LDLT compared to deceased donor transplants. ^{1 2 3 4 5}

How does the Live Donor Champion Program for Liver Disease treatment differ from other treatments for liver disease?

The Live Donor Champion Program for Liver Disease is unique because it involves living donor liver transplantation, which allows patients to receive transplants when they are medically optimized and provides liver segments with minimal damage. This approach addresses the shortage of donor organs and is increasingly recognized as an effective treatment with excellent patient survival rates. ^{5 6 7 8 9}

What is the purpose of this trial?

This trial tests a program that trains someone close to liver transplant candidates to help them find living donors. It aims to reduce waiting times and improve outcomes by providing education and advocacy training.

Research Team

Elizabeth A King, MD PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for adults over 18 who speak English, are mentally able to consent, and are on the liver transplant waitlist without any current living donors. It's not for those under 18, non-English speakers, anyone with potential live donors already identified, or patients who have had a previous liver transplant or need multiple organs.

Inclusion Criteria

I am on the waiting list for a liver transplant.

Be English speaking

I am mentally capable of understanding and agreeing to the trial's procedures.

Exclusion Criteria

I have had a liver transplant.

I am on the waiting list for multiple organ transplants.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education and Advocacy Training

Participants and their Live Donor Champions receive education and advocacy training through the Liver Live Donor Champion program, consisting of 2 or 3 monthly sessions.

2-3 months

2 or 3 sessions (in-person)

Follow-up

Participants are monitored for live donor inquiries and transplantation outcomes, as well as knowledge and comfort with live donation.

6 months

Long-term Follow-up

Participants are monitored for live donor inquiries and transplantation outcomes over a longer period.

2 years

Treatment Details

Interventions

• Liver Live Donor Champion Program

Trial Overview The study tests an educational and advocacy program called the Liver Live Donor Champion Program. This pilot will evaluate two versions of the program to see how well they help expand access to live donor liver transplants by training 'Live Donor Champions' alongside transplant candidates.

Participant Groups

Group I: Liver Live Donor Champion Experimental Treatment 1 Intervention

The Liver Live Donor Champion program (LLDC) is the sole educational intervention for this trial. LLDC consists of 2 or 3 monthly sessions (depending on cohort) of approximately 2 or 3 hours each. Each LLDC session is led by a transplant physician or clinical coordinator. The sessions incorporate formal didactics, active-participant learning, personal stories, moderated group discussions, role-playing, and other skill-building exercises. LLDC session topics are as follows: 1) education about End-Stage Liver Disease (ESLD), liver transplantation, and living donation 2) communication skills building 3) Exploring social networks 4) sharing successful donor and recipient stories 5) surgeon and hepatologist panel 6) Program Recap.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Living donor liver transplantation (LDLT) significantly reduces waitlist mortality and offers excellent long-term outcomes for patients with end-stage liver disease, yet its use in the US remains limited.

A consensus conference identified cultural beliefs and behaviors as major barriers to expanding LDLT, emphasizing the need for education and engagement to shift perceptions and promote LDLT as the preferred option for liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living donor liver transplantation: A multi-disciplinary collaboration towards growth, consensus, and a change in culture. Liapakis, A., Jesse, MT., Pillai, A., et al.[2023]

References

1. India pubmed.ncbi.nlm.nih.gov

Poor Performance Status Predicts Mortality After Living Donor Liver Transplantation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Living Donor Liver Transplantation Compared with Deceased Donor Liver Transplantation. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Associations Among Different Domains of Quality Among US Liver Transplant Programs. [2022]

4. Denmark pubmed.ncbi.nlm.nih.gov

Living donor liver transplantation: A multi-disciplinary collaboration towards growth, consensus, and a change in culture. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

One hundred nine living donor liver transplants in adults and children: a single-center experience. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adult-to-adult living donor liver transplantation: history, current practice, and implications for the future. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Marginal parental donors for pediatric living donor liver transplantation. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Living organ donor transplantation--the German experience in comparison to others]. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Living donor liver transplantation: summary of a conference at The National Institutes of Health. [2018]