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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00096733
Recruitment Status : Completed
First Posted : November 15, 2004
Last Update Posted : August 29, 2017
American Society of Transplant Surgeons
Health Resources and Services Administration (HRSA)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Arbor Research Collaborative for Health

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
Cirrhosis Hepatitis C Hepatocellular Carcinoma

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.

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Study Type : Observational
Actual Enrollment : 2470 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Adult-to-Adult Living Donor Liver Transplantation Cohort Study
Study Start Date : October 2004
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Survival of the potential liver transplant recipient [ Time Frame: 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 :
  1. Recipient survival from time of transplant (either living or deceased donor) [ Time Frame: 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:
  1. Donor complications [ Time Frame: From the time of donation until last follow-up ]
    Donor complications are recorded, and graded using the Clavien scale.

  2. Recipient complications [ Time Frame: From time of transplantation until last follow-up ]
    Recipient complications are recorded, and graded using the Clavien scale.

Biospecimen Retention:   Samples With DNA
whole blood, serum, fixed tissue samples, frozen tissue samples

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00096733

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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
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)
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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

Publications of Results:
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.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Arbor Research Collaborative for Health Identifier: NCT00096733     History of Changes
Other Study ID Numbers: A2ALL
U01DK062498-01 ( U.S. NIH Grant/Contract )
First Posted: November 15, 2004    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Arbor Research Collaborative for Health:
Living donors
Organ procurement
Liver transplantation
Hepatitis C
Hepatocellular carcinoma
Liver regeneration
Graft rejection
Quality of life
Informed consent

Additional relevant MeSH terms:
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Hepatitis C
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Liver Extracts