Adult-to-Adult Living Donor Liver Transplantation Study (A2ALL-1)
|Study Design:||Observational Model: Cohort|
|Official Title:||Adult-to-Adult Living Donor Liver Transplantation Cohort Study|
- Survival of the potential liver transplant recipient [ Time Frame: Time from living donor evaluation to death ] [ Designated as safety issue: Yes ]Time from evaluation of a living liver donor until death of the potential recipient, to test the benefit of living liver donation.
- Recipient survival from time of transplant (either living or deceased donor) [ Time Frame: From transplant until death or last follow-up ] [ Designated as safety issue: No ]Recipient survival from transplant to death. The goal is to compare survival among living donor versus deceased donor recipients.
- Donor complications [ Time Frame: From the time of donation until last follow-up ] [ Designated as safety issue: Yes ]Donor complications are recorded, and graded using the Clavien scale.
- Recipient complications [ Time Frame: From time of transplantation until last follow-up ] [ Designated as safety issue: Yes ]Recipient complications are recorded, and graded using the Clavien scale.
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2004|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096733
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095-7054|
|University of California San Francisco|
|San Francisco, California, United States, 94143-0538|
|United States, Colorado|
|University of Colorado Health System|
|Denver, Colorado, United States, 80262|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|New York, New York, United States, 10032|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27599-7210|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908-0708|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23219|
|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|