Adult-to-Adult Living Donor Transplant Cohort Study (A2ALL-2)
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.
End Stage Liver Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A2ALL: Adult-to-Adult Living Transplant Cohort Study|
- 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.
|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)|
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).
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619475
|Contact: Peg Hill-Callahan, BS, LSW||734-369-9674||Peg.Hill-Callahan@ArborResearch.org|
|Contact: Diane Hilfinger, MA||734-369-9678||diane.hilfinger@ArborResearch.org|
|United States, California|
|University of California||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Dulce MacLeod 415-476-3170 Dulce.Macleod@ucsfmedctr.org|
|Principal Investigator: Chris E. Freise, MD|
|United States, Colorado|
|University of Colorado Health Sciences||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Seda Carlton 303-724-1868 firstname.lastname@example.org|
|Principal Investigator: James Burton, MD|
|United States, Illinois|
|Northwestern University, Division of Transplantation||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Patrice Al-Saden 312-694-0232 email@example.com|
|Principal Investigator: Michael M. Abecassis, MD, MBA|
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Contact: Agnes Trabucco 781-744-3367 Agnes.Trabucco@Lahey.org|
|Principal Investigator: Elizabeth Pomfret, MD|
|United States, New York|
|New York, New York, United States, 10032|
|Contact: Tarek Mansour 212-305-3839 firstname.lastname@example.org|
|Principal Investigator: Jean C Emond, MD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Debra McCorriston 215-662-2107 email@example.com|
|Principal Investigator: Kim M. Olthoff, MD|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15213|
|Contact: Leslie Mitrik 412-682-1645 firstname.lastname@example.org|
|Principal Investigator: Abhinav Humar, MD|
|United States, Virginia|
|Virginia Commonwealth University-Medical College of Virginia||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: JoAnne L Davis 804-828-7921 email@example.com|
|Principal Investigator: Robert A. Fisher, MD|
|University of Toronto||Recruiting|
|Toronto, Ontario, Canada, M5G 2N2|
|Contact: Erin Winter 416-340-4800 ext 6093 Erin.Winter@uhn.ca|
|Principal Investigator: David Grant, MD|
|Study Chair:||Robert M Merion, MD||University of Michigan|
|Study Director:||Averell Sherker, MD||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|