Adult-to-Adult Living Donor Liver Transplantation Study (A2ALL-1)

This study has been completed.
Sponsor:
Collaborators:
American Society of Transplant Surgeons
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Robert Merion, University of Michigan
ClinicalTrials.gov Identifier:
NCT00096733
First received: November 12, 2004
Last updated: December 7, 2012
Last verified: December 2012

November 12, 2004
December 7, 2012
October 2004
August 2010   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00096733 on ClinicalTrials.gov Archive Site
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.
Not Provided
  • 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.
Not Provided
 
Adult-to-Adult Living Donor Liver Transplantation Study
Adult-to-Adult Living Donor Liver Transplantation Cohort Study

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.

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.

Observational
Observational Model: Cohort
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, fixed tissue samples, frozen tissue samples

Non-Probability Sample

Potential recipients and donors for transplantation will be evaluated and invited to participate in the study if they are eligible for LDLT using standard criteria for this procedure according to the practice of the transplant center.

  • Cirrhosis
  • Hepatitis C
  • Hepatocellular Carcinoma
Not Provided
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2470
August 2010
August 2010   (final data collection date for primary outcome measure)

Inclusion Criteria - Potential Recipients:

  • Potential recipient listed for single organ (liver) transplantation
  • Patient is eligible for LDLT
  • Age ≥ 18 years old at the time of donor history and physical exam
  • Indication for transplant: non-fulminant liver disease
  • Potential donor scheduled for evaluation (history and physical examination) within four weeks

Inclusion Criteria - Potential Donors:

  • Meet donor criteria of the transplant center
  • Age >= 18 years old at donation
  • Be evaluated with a history and physical examination at the transplant center
  • Potential donor's recipient listed for single organ (liver) transplantation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00096733
A2ALL (IND), U01DK062498-01
No
Robert Merion, University of Michigan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • American Society of Transplant Surgeons
  • Health Resources and Services Administration (HRSA)
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP