Adult-to-Adult Living Donor Transplant Cohort Study (A2ALL-2)
|ClinicalTrials.gov Identifier: NCT01619475|
Recruitment Status : Completed
First Posted : June 14, 2012
Last Update Posted : August 29, 2017
The study is being conducted for the following reasons:
- To determine the prevalence, course, and predictors of poor Health Related Quality of Life (HRQOL) outcomes associated with living donor donation.
- 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.
- To study the effects of pressure and flow on the outcomes of LDLT.
- 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.
- To compare the long-term histological outcomes in recipients of LDLT and deceased donor liver transplant (DDLT) with recurrent hepatitis C virus (HCV) infection.
- To understand the history of pain management and to measure quality of care in pain control in living donors following partial hepatectomy.
|Condition or disease|
|Liver Diseases Hepatocellular Cancer End Stage Liver Disease Hepatitis C Liver Cirrhosis|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||1871 participants|
|Official Title:||A2ALL: Adult-to-Adult Living Transplant Cohort Study|
|Actual Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Individuals approved as liver donors and recipients shortly Pre-donation/Pre-transplant at the study sites.
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).
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619475
|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|
|Burlington, Massachusetts, United States, 01805|
|United States, New York|
|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|
|University of Toronto|
|Toronto, Ontario, Canada, M5G 2N2|
|Study Chair:||Robert M Merion, MD||University of Michigan|
|Study Director:||Averell Sherker, MD||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|