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
  Purpose

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
Cirrhosis
Hepatitis C
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Adult-to-Adult Living Donor Liver Transplantation Cohort Study

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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

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


Enrollment: 2470
Study Start Date: October 2004
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096733

Locations
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
Northwestern University
Chicago, Illinois, United States, 60611
United States, New York
Columbia University
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
Sponsors and Collaborators
American Society of Transplant Surgeons
Health Resources and Services Administration (HRSA)
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
  More Information

Additional Information:
Publications:
Berg CL, Abecassis M, Brown RS, Everhart JE, Gillespie BW, Hulbert-Shearon TE, Merion RM. Living donor liver transplantation reduces the risk of death of transplant candidates. Hepatology 2004; 40(4)(Suppl 1): 209A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Merion, Professor of Surgery, University of Michigan
ClinicalTrials.gov Identifier: NCT00096733     History of Changes
Other Study ID Numbers: A2ALL (IND), U01DK062498-01
Study First Received: November 12, 2004
Last Updated: December 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Living donors
Organ procurement
Liver transplantation
Hepatitis C
Hepatocellular carcinoma
Hepatectomy
Liver regeneration
Graft rejection
Quality of life
Informed consent

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 22, 2014