A2ALL-1: Adult-to-Adult Living Donor Liver Transplantation Study
Study Details
Study Description
Brief Summary
There are two principal purposes of this study: 1) to determine whether it is more beneficial for a liver transplant recipient candidate to pursue a living donor liver transplant (LDLT) or wait for a deceased donor liver transplant (DDLT), and 2) to study the impact of liver donation on the donor's health and quality of life.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Adult to adult living donor liver transplantation (LDLT) is a relatively new procedure increasingly used at major transplantation centers. Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers. Therefore, a network of nine leading liver transplantation centers and a data coordination center (DCC) has been organized to accrue and follow sufficient numbers of patients being considered for and undergoing LDLT to provide generalizable results from adequately powered studies. This network has established the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) that will conduct both retrospective and prospective studies of LDLT.
The primary study objective is to analyze the effect of choosing to pursue living liver donation. The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated (at least a history and physical examination). Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT. The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant. Finally, a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure.
Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Donors Living liver donors. This label may also refer to those evaluated for liver donation who did not go on to donate, i.e., potential living liver donors. |
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| Recipients Liver transplant recipients (either living or deceased donor). This label may also refer to those who were evaluated for liver transplantation, but never received a transplant, i.e., potential recipients. |
Outcome Measures
Primary Outcome Measures
- Survival of the potential liver transplant recipient [Time from living donor evaluation to death]
Time from evaluation of a living liver donor until death of the potential recipient, to test the benefit of living liver donation.
Secondary Outcome Measures
- Recipient survival from time of transplant (either living or deceased donor) [From transplant until death or last follow-up]
Recipient survival from transplant to death. The goal is to compare survival among living donor versus deceased donor recipients.
Other Outcome Measures
- Donor complications [From the time of donation until last follow-up]
Donor complications are recorded, and graded using the Clavien scale.
- Recipient complications [From time of transplantation until last follow-up]
Recipient complications are recorded, and graded using the Clavien scale.
Eligibility Criteria
Criteria
Inclusion Criteria - Potential Recipients:
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Potential recipient listed for single organ (liver) transplantation
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Patient is eligible for LDLT
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Age ≥ 18 years old at the time of donor history and physical exam
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Indication for transplant: non-fulminant liver disease
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Potential donor scheduled for evaluation (history and physical examination) within four weeks
Inclusion Criteria - Potential Donors:
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Meet donor criteria of the transplant center
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Age >= 18 years old at donation
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Be evaluated with a history and physical examination at the transplant center
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Potential donor's recipient listed for single organ (liver) transplantation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California Los Angeles | Los Angeles | California | United States | 90095-7054 |
| 2 | University of California San Francisco | San Francisco | California | United States | 94143-0538 |
| 3 | University of Colorado Health System | Denver | Colorado | United States | 80262 |
| 4 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 5 | Columbia University | New York | New York | United States | 10032 |
| 6 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599-7210 |
| 7 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
| 8 | University of Virginia | Charlottesville | Virginia | United States | 22908-0708 |
| 9 | Virginia Commonwealth University | Richmond | Virginia | United States | 23219 |
Sponsors and Collaborators
- Arbor Research Collaborative for Health
- American Society of Transplant Surgeons
- Health Resources and Services Administration (HRSA)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Study Chair: Robert M Merion, MD, University of Michigan - A2ALL Data Coordinating Center
- Study Chair: Carl L Berg, MD, University of Virginia Health System
- Study Chair: Jean Emond, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A2ALL
- U01DK062498-01