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Adult-to-Adult Living Donor Transplant Cohort Study (A2ALL-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01619475
First Posted: June 14, 2012
Last Update Posted: August 29, 2017
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.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Arbor Research Collaborative for Health
  Purpose

The study is being conducted for the following reasons:

  1. To determine the prevalence, course, and predictors of poor Health Related Quality of Life (HRQOL) outcomes associated with living donor donation.
  2. To collect data and biosamples prior to, during, and after a living donor liver transplant (LDLT) among all donors and recipients for use by other adult-to-adult living donor liver transplant studies and future studies.
  3. To study the effects of pressure and flow on the outcomes of LDLT.
  4. To characterize the differences between living donor liver transplant and deceased donor liver transplant in terms of recipient post-transplant outcomes including patient and graft survival, surgical morbidity, and resource utilization.
  5. To compare the long-term histological outcomes in recipients of LDLT and deceased donor liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.
  6. To understand the history of pain management and to measure quality of care in pain control in living donors following partial hepatectomy.

Condition
Liver Diseases Hepatocellular Cancer End Stage Liver Disease Hepatitis C Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A2ALL: Adult-to-Adult Living Transplant Cohort Study

Resource links provided by NLM:


Further study details as provided by Arbor Research Collaborative for Health:

Primary Outcome Measures:
  • Recipient patient and graft survival starting from the time of transplantation in LDLT & DDLT. [ Time Frame: Yearly follow-up starting at transplant, measured between enrollment and up to 4 years. ]
    To characterize the differences between LDLT and DDLT in terms of recipient post-transplant outcomes for patient and graft survival.

  • Number and severity of surgical complications and resource utilization after transplant. [ Time Frame: Yearly follow-up starting at transplant, measured between enrollment , and up to 4 years. ]

    Comparison of incidence of defined medical and surgical complications after transplant between LDLT and DDLT.

    Comparison of resource utilization (hospitalization) between LDLT and DDLT.


  • Health Related Quality of Life (HRQOL) in living liver donors. [ Time Frame: Yearly assessment from donation up to 5 assessments. ]
    To estimate the prevalence, course, and predictors of poor HRQOL outcomes associated with living liver donation.

  • Number of Blood/Tissue Samples from Donors and Recipients. [ Time Frame: Yearly samples starting at transplant/donation (donors until year 1, and recipients until year 4.) ]
    To collect data and biosamples prior to, during, and after LDLT among all donors and recipients for use by other A2ALL protocols and future studies.

  • Pressure and Flow Measurements during the transplant surgery in LDLT recipients. [ Time Frame: During the transplant (at completion of dissection, and after revascularization). ]
    To establish normal hepatic blood flow and portal compliance in the human liver, to examine the relationships among hepatic flow and pressure, graft size and function, and clinical outcomes.

  • Measures of liver fibrosis (Ishak score) in LDLT and DDLT recipients with recurrent HCV infection. [ Time Frame: Enrollment up to 4 years, with data collected at the time of each liver biopsy. ]
    To assess whether recurrent Hepatitis C is histologically less severe in LDLT compared with DDLT recipients.

  • Pain control in living donors following partial hepatectomy [ Time Frame: The first 48 hours after donation surgery ]
    Self-reported pain and satisfaction with pain management during the first 48 hours after donation surgery.


Biospecimen Retention:   Samples With DNA
To collect biosamples prior to, during, and after LDLT among all donors and recipients. These biosamples include, liver biopsy,whole blood for genetic studies and DNA extraction, plasma, serum and peripheral cells to be retained in the bio-repository.

Enrollment: 1871
Actual Study Start Date: February 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prospective
Individuals approved as liver donors and recipients shortly Pre-donation/Pre-transplant at the study sites.
Long-Term Follow-up

Donors and recipients enrolled in the original A2ALL Cohort study.

Donors and LDLT recipients whose donation/transplant occurred during the period of time that began with the end of enrollment into the original Cohort study (Aug. 31, 2009) and ended with the opening of the enrollment in the current core protocol; this is referred to as the "Gap Era."

LDLT recipients and donors who were not in the original Cohort study or from the Gap Era will enter the study at time proximate to time of living donation.

HCV-Infected Liver Transplant Recipients
Male and female HCV-infected adult liver transplant recipients from those enrolled in the A2ALL-1 Cohort study and from those concurrently transplanted at the new A2ALL-2 centers (University of Toronto, University of Pittsburgh, Lahey Clinic).

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The sample population will consist of the following:

  • Donors and LDLT and DDLT recipients enrolled in the original A2ALL cohort study.
  • Donors and LDLT recipients where the donation/transplant occurred during the period of time that began with the end of enrollment into the original Cohort study (August 31, 2009) and ended with the opening of enrollment in the current core protocol; this is referred to as the "Gap Era."
  • Prospective donors and LDLT recipients for donation/transplant surgery.
  • HCV-infected adult liver transplant recipients enrolled in the A2ALL-1 Cohort and from those currently transplanted at the new A2ALL-2 centers (University of Toronto, University of Pittsburgh, and Lahey Clinic).
Criteria

Inclusion Criteria:

Recipients

  1. Age 18 or older at the time of consent
  2. Has had a living donor identified and accepted and LDLT is planned
  3. Informed consent obtained
  4. Is listed for single organ (liver) transplantation

Donors

  1. Age 18 or older at the time of consent
  2. Has undergone donor evaluation process and was accepted and donation surgery is planned
  3. Informed consent obtained

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01619475


Locations
United States, California
University of California
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado Health Sciences
Aurora, Colorado, United States, 80045
United States, Illinois
Northwestern University, Division of Transplantation
Chicago, Illinois, United States, 60611
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
Virginia Commonwealth University-Medical College of Virginia
Richmond, Virginia, United States, 23298
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5G 2N2
Sponsors and Collaborators
Arbor Research Collaborative for Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Study Chair: Robert M Merion, MD University of Michigan
Study Director: Averell Sherker, MD National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:
Berg CL, Gillespie BW, Merion RM, Brown RS Jr, Abecassis MM, Trotter JF, Fisher RA, Freise CE, Ghobrial RM, Shaked A, Fair JH, Everhart JE; A2ALL Study Group. Improvement in survival associated with adult-to-adult living donor liver transplantation. Gastroenterology. 2007 Dec;133(6):1806-13. Epub 2007 Sep 14.
Abecassis MM, Fisher RA, Olthoff KM, Freise CE, Rodrigo DR, Samstein B, Kam I, Merion RM; A2ALL Study Group. Complications of living donor hepatic lobectomy--a comprehensive report. Am J Transplant. 2012 May;12(5):1208-17. doi: 10.1111/j.1600-6143.2011.03972.x. Epub 2012 Feb 15.
Berg CL, Merion RM, Shearon TH, Olthoff KM, Brown RS Jr, Baker TB, Everson GT, Hong JC, Terrault N, Hayashi PH, Fisher RA, Everhart JE. Liver transplant recipient survival benefit with living donation in the model for endstage liver disease allocation era. Hepatology. 2011 Oct;54(4):1313-21. doi: 10.1002/hep.24494.
Butt Z, Dew MA, Liu Q, Simpson MA, Smith AR, Zee J, Gillespie BW, Abbey SE, Ladner DP, Weinrieb R, Fisher RA, Hafliger S, Terrault N, Burton J, Sherker AH, DiMartini A. Psychological Outcomes of Living Liver Donors From a Multicenter Prospective Study: Results From the Adult-to-Adult Living Donor Liver Transplantation Cohort Study2 (A2ALL-2). Am J Transplant. 2017 May;17(5):1267-1277. doi: 10.1111/ajt.14134. Epub 2017 Jan 3.
Dew MA, DiMartini AF, Ladner DP, Simpson MA, Pomfret EA, Gillespie BW, Merion RM, Zee J, Smith AR, Holtzman S, Sherker AH, Weinrieb R, Fisher RA, Emond JC, Freise CE, Burton JR Jr, Butt Z. Psychosocial Outcomes 3 to 10 Years After Donation in the Adult to Adult Living Donor Liver Transplantation Cohort Study. Transplantation. 2016 Jun;100(6):1257-69. doi: 10.1097/TP.0000000000001144.
DiMartini AF, Dew MA, Butt Z, Simpson MA, Ladner DP, Smith AR, Hill-Callahan P, Gillespie BW. Patterns and predictors of sexual function after liver donation: The Adult-to-Adult Living Donor Liver Transplantation Cohort study. Liver Transpl. 2015 May;21(5):670-82. doi: 10.1002/lt.24108.
DiMartini A, Dew MA, Liu Q, Simpson MA, Ladner DP, Smith AR, Zee J, Abbey S, Gillespie BW, Weinrieb R, Mandell MS, Fisher RA, Emond JC, Freise CE, Sherker AH, Butt Z. Social and Financial Outcomes of Living Liver Donation: A Prospective Investigation Within the Adult-to-Adult Living Donor Liver Transplantation Cohort Study 2 (A2ALL-2). Am J Transplant. 2017 Apr;17(4):1081-1096. doi: 10.1111/ajt.14055. Epub 2016 Nov 10.
Emond JC, Fisher RA, Everson G, Samstein B, Pomposelli JJ, Zhao B, Forney S, Olthoff KM, Baker TB, Gillespie BW, Merion RM. Changes in liver and spleen volumes after living liver donation: a report from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL). Liver Transpl. 2015 Feb;21(2):151-61. doi: 10.1002/lt.24062.
Emond JC, Goodrich NP, Pomposelli JJ, Baker TB, Humar A, Grant DR, Abt P, Friese CE, Fisher RA, Kam I, Sherker AH, Gillespie BW, Merion RM. Hepatic Hemodynamics and Portal Flow Modulation: The A2ALL Experience. Transplantation. 2017 Oct;101(10):2375-2384. doi: 10.1097/TP.0000000000001823.
Everson GT, Hoefs JC, Niemann CU, Olthoff KM, Dupuis R, Lauriski S, Herman A, Milne N, Gillespie BW, Goodrich NP, Everhart JE. Functional elements associated with hepatic regeneration in living donors after right hepatic lobectomy. Liver Transpl. 2013 Mar;19(3):292-304. doi: 10.1002/lt.23592.
Everson GT, Terrault NA, Lok AS, Rodrigo del R, Brown RS Jr, Saab S, Shiffman ML, Al-Osaimi AM, Kulik LM, Gillespie BW, Everhart JE; Adult-to-Adult Living Donor Liver Transplantation Cohort Study. A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation. Hepatology. 2013 May;57(5):1752-62. doi: 10.1002/hep.25976. Epub 2013 Jan 17.
Gillespie BW, Merion RM, Ortiz-Rios E, Tong L, Shaked A, Brown RS, Ojo AO, Hayashi PH, Berg CL, Abecassis MM, Ashworth AS, Friese CE, Hong JC, Trotter JF, Everhart JE; A2ALL Study Group. Database comparison of the adult-to-adult living donor liver transplantation cohort study (A2ALL) and the SRTR U.S. Transplant Registry. Am J Transplant. 2010 Jul;10(7):1621-33. doi: 10.1111/j.1600-6143.2010.03039.x. Epub 2010 Feb 25.
Gordon FD, Goldberg DS, Goodrich NP, Lok AS, Verna EC, Selzner N, Stravitz RT, Merion RM. Recurrent primary sclerosing cholangitis in the Adult-to-Adult Living Donor Liver Transplantation Cohort Study: Comparison of risk factors between living and deceased donor recipients. Liver Transpl. 2016 Sep;22(9):1214-22. doi: 10.1002/lt.24496. Epub 2016 Aug 2.
Kulik LM, Fisher RA, Rodrigo DR, Brown RS Jr, Freise CE, Shaked A, Everhart JE, Everson GT, Hong JC, Hayashi PH, Berg CL, Lok AS; A2ALL Study Group. Outcomes of living and deceased donor liver transplant recipients with hepatocellular carcinoma: results of the A2ALL cohort. Am J Transplant. 2012 Nov;12(11):2997-3007. doi: 10.1111/j.1600-6143.2012.04272.x. Epub 2012 Sep 20.
Ladner DP, Dew MA, Forney S, Gillespie BW, Brown RS Jr, Merion RM, Freise CE, Hayashi PH, Hong JC, Ashworth A, Berg CL, Burton JR Jr, Shaked A, Butt Z. Long-term quality of life after liver donation in the adult to adult living donor liver transplantation cohort study (A2ALL). J Hepatol. 2015 Feb;62(2):346-53. doi: 10.1016/j.jhep.2014.08.043. Epub 2014 Sep 6.
Levitsky J, Goldberg D, Smith AR, Mansfield SA, Gillespie BW, Merion RM, Lok AS, Levy G, Kulik L, Abecassis M, Shaked A. Acute Rejection Increases Risk of Graft Failure and Death in Recent Liver Transplant Recipients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):584-593.e2. doi: 10.1016/j.cgh.2016.07.035. Epub 2016 Aug 25.
Mandell MS, Smith AR, Dew MA, Gordon DB, Holtzman S, Howell T, DiMartini AF, Butt Z, Simpson MA, Ladner DP, Freise CE, McCluskey SA, Fisher RA, Guarrera JV, Olthoff KM, Pomfret EA. Early Postoperative Pain and its Predictors in the Adult to Adult Living Donor Liver Transplantation Cohort Study. Transplantation. 2016 Nov;100(11):2362-2371.
Merion RM, Shearon TH, Berg CL, Everhart JE, Abecassis MM, Shaked A, Fisher RA, Trotter JF, Brown RS Jr, Terrault NA, Hayashi PH, Hong JC; A2ALL Study Group. Hospitalization rates before and after adult-to-adult living donor or deceased donor liver transplantation. Ann Surg. 2010 Mar;251(3):542-9. doi: 10.1097/SLA.0b013e3181ccb370.
Olthoff KM, Emond JC, Shearon TH, Everson G, Baker TB, Fisher RA, Freise CE, Gillespie BW, Everhart JE. Liver regeneration after living donor transplantation: adult-to-adult living donor liver transplantation cohort study. Liver Transpl. 2015 Jan;21(1):79-88. doi: 10.1002/lt.23966. Epub 2014 Oct 6.
Olthoff KM, Smith AR, Abecassis M, Baker T, Emond JC, Berg CL, Beil CA, Burton JR Jr, Fisher RA, Freise CE, Gillespie BW, Grant DR, Humar A, Kam I, Merion RM, Pomfret EA, Samstein B, Shaked A. Defining long-term outcomes with living donor liver transplantation in North America. Ann Surg. 2015 Sep;262(3):465-75; discussion 473-5. doi: 10.1097/SLA.0000000000001383.
Pomposelli JJ, Goodrich NP, Emond JC, Humar A, Baker TB, Grant DR, Fisher RA, Roberts JP, Olthoff KM, Gillespie BW, Merion RM. Patterns of Early Allograft Dysfunction in Adult Live Donor Liver Transplantation: The A2ALL Experience. Transplantation. 2016 Jul;100(7):1490-9. doi: 10.1097/TP.0000000000001240.
Samstein B, Smith AR, Freise CE, Zimmerman MA, Baker T, Olthoff KM, Fisher RA, Merion RM. Complications and Their Resolution in Recipients of Deceased and Living Donor Liver Transplants: Findings From the A2ALL Cohort Study. Am J Transplant. 2016 Feb;16(2):594-602. doi: 10.1111/ajt.13479. Epub 2015 Oct 13.
Terrault NA, Stravitz RT, Lok AS, Everson GT, Brown RS Jr, Kulik LM, Olthoff KM, Saab S, Adeyi O, Argo CK, Everhart JE, Rodrigo del R; A2ALL Study Group. Hepatitis C disease severity in living versus deceased donor liver transplant recipients: an extended observation study. Hepatology. 2014 Apr;59(4):1311-9. doi: 10.1002/hep.26920. Epub 2014 Mar 1.
Zimmerman MA, Baker T, Goodrich NP, Freise C, Hong JC, Kumer S, Abt P, Cotterell AH, Samstein B, Everhart JE, Merion RM. Development, management, and resolution of biliary complications after living and deceased donor liver transplantation: a report from the adult-to-adult living donor liver transplantation cohort study consortium. Liver Transpl. 2013 Mar;19(3):259-67. doi: 10.1002/lt.23595.
Olthoff KM, Merion RM, Ghobrial RM, Abecassis MM, Fair JH, Fisher RA, Freise CE, Kam I, Pruett TL, Everhart JE, Hulbert-Shearon TE, Gillespie BW, Emond JC; A2ALL Study Group. Outcomes of 385 adult-to-adult living donor liver transplant recipients: a report from the A2ALL Consortium. Ann Surg. 2005 Sep;242(3):314-23, discussion 323-5.
Freise CE, Gillespie BW, Koffron AJ, Lok AS, Pruett TL, Emond JC, Fair JH, Fisher RA, Olthoff KM, Trotter JF, Ghobrial RM, Everhart JE; A2ALL Study Group. Recipient morbidity after living and deceased donor liver transplantation: findings from the A2ALL Retrospective Cohort Study. Am J Transplant. 2008 Dec;8(12):2569-79. doi: 10.1111/j.1600-6143.2008.02440.x. Epub 2008 Oct 24.
Trotter JF, Hill-Callahan MM, Gillespie BW, Nielsen CA, Saab S, Shrestha R, Talamantes MM, Weinrieb RM; A2ALL Study Group. Severe psychiatric problems in right hepatic lobe donors for living donor liver transplantation. Transplantation. 2007 Jun 15;83(11):1506-8.
Trotter JF, Wisniewski KA, Terrault NA, Everhart JE, Kinkhabwala M, Weinrieb RM, Fair JH, Fisher RA, Koffron AJ, Saab S, Merion RM; A2ALL Study Group. Outcomes of donor evaluation in adult-to-adult living donor liver transplantation. Hepatology. 2007 Nov;46(5):1476-84.
Terrault NA, Shiffman ML, Lok AS, Saab S, Tong L, Brown RS Jr, Everson GT, Reddy KR, Fair JH, Kulik LM, Pruett TL, Seeff LB; A2ALL Study Group. Outcomes in hepatitis C virus-infected recipients of living donor vs. deceased donor liver transplantation. Liver Transpl. 2007 Jan;13(1):122-9.
Fisher RA, Kulik LM, Freise CE, Lok AS, Shearon TH, Brown RS Jr, Ghobrial RM, Fair JH, Olthoff KM, Kam I, Berg CL; A2ALL Study Group. Hepatocellular carcinoma recurrence and death following living and deceased donor liver transplantation. Am J Transplant. 2007 Jun;7(6):1601-8.
Campsen J, Blei AT, Emond JC, Everhart JE, Freise CE, Lok AS, Saab S, Wisniewski KA, Trotter JF; Adult-to-Adult Living Donor Liver Transplantation Cohort Study Group. Outcomes of living donor liver transplantation for acute liver failure: the adult-to-adult living donor liver transplantation cohort study. Liver Transpl. 2008 Sep;14(9):1273-80. doi: 10.1002/lt.21500.
Ghobrial RM, Freise CE, Trotter JF, Tong L, Ojo AO, Fair JH, Fisher RA, Emond JC, Koffron AJ, Pruett TL, Olthoff KM; A2ALL Study Group. Donor morbidity after living donation for liver transplantation. Gastroenterology. 2008 Aug;135(2):468-76. doi: 10.1053/j.gastro.2008.04.018. Epub 2008 Apr 22.
Shaked A, Ghobrial RM, Merion RM, Shearon TH, Emond JC, Fair JH, Fisher RA, Kulik LM, Pruett TL, Terrault NA; A2ALL Study Group. Incidence and severity of acute cellular rejection in recipients undergoing adult living donor or deceased donor liver transplantation. Am J Transplant. 2009 Feb;9(2):301-8. doi: 10.1111/j.1600-6143.2008.02487.x. Epub 2008 Dec 15.
Trotter JF, Gillespie BW, Terrault NA, Abecassis MM, Merion RM, Brown RS Jr, Olthoff KM, Hayashi PH, Berg CL, Fisher RA, Everhart JE; Adult-to-Adult Living Donor Liver Transplantation Cohort Study Group. Laboratory test results after living liver donation in the adult-to-adult living donor liver transplantation cohort study. Liver Transpl. 2011 Apr;17(4):409-17. doi: 10.1002/lt.22246.
Olthoff KM, Abecassis MM, Emond JC, Kam I, Merion RM, Gillespie BW, Tong L; Adult-to-Adult Living Donor Liver Transplantation Cohort Study Group. Outcomes of adult living donor liver transplantation: comparison of the Adult-to-adult Living Donor Liver Transplantation Cohort Study and the national experience. Liver Transpl. 2011 Jul;17(7):789-97. doi: 10.1002/lt.22288.

Responsible Party: Arbor Research Collaborative for Health
ClinicalTrials.gov Identifier: NCT01619475     History of Changes
Other Study ID Numbers: A2ALL Core Protocol
U01DK085587 ( U.S. NIH Grant/Contract )
U01DK085563 ( U.S. NIH Grant/Contract )
U01DK085515 ( U.S. NIH Grant/Contract )
U01DK062536 ( U.S. NIH Grant/Contract )
U01DK062531 ( U.S. NIH Grant/Contract )
U01DK062498 ( U.S. NIH Grant/Contract )
U01DK062494 ( U.S. NIH Grant/Contract )
U01DK062483 ( U.S. NIH Grant/Contract )
U01DK062467 ( U.S. NIH Grant/Contract )
U01DK062444 ( U.S. NIH Grant/Contract )
5U01DK062498-09 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2011
First Posted: June 14, 2012
Last Update Posted: August 29, 2017
Last Verified: August 2017

Keywords provided by Arbor Research Collaborative for Health:
Living Donor
Liver Transplantation
Quality of Life
Biosamples
Liver Recipient

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Liver Cirrhosis
Liver Neoplasms
End Stage Liver Disease
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Failure
Hepatic Insufficiency


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