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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Beth Golden, National Institute of Diabetes and Digestive and Kidney Diseases
ClinicalTrials.gov Identifier:
NCT01619475
First received: October 5, 2011
Last updated: May 28, 2014
Last verified: May 2014
  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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]
    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.) ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 1900
Study Start Date: February 2011
Estimated Study Completion Date: August 2014
Estimated 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
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: 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
Beth Golden
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:

Responsible Party: Beth Golden, Lead Clinical Monitor, National Institute of Diabetes and Digestive and Kidney Diseases
ClinicalTrials.gov Identifier: NCT01619475     History of Changes
Other Study ID Numbers: A2ALL Core Protocol  5U01DK062498-09 
Study First Received: October 5, 2011
Last Updated: May 28, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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

ClinicalTrials.gov processed this record on December 02, 2016