Adult-to-Adult Living Donor Transplant Cohort Study (A2ALL-2)
This study is currently recruiting participants.
Verified July 2012 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
Monique Lowe
Collaborator:
Information provided by (Responsible Party):
Monique Lowe, National Institute of Diabetes and Digestive and Kidney Diseases
ClinicalTrials.gov Identifier:
NCT01619475
First received: October 5, 2011
Last updated: July 25, 2012
Last verified: July 2012
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Purpose
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 |
|---|
|
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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Cancer
Cirrhosis
Hepatitis
Hepatitis A
Hepatitis C
Liver Cancer
Liver Diseases
Liver Transplantation
U.S. FDA Resources
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 donation/transplant surgery in LDLT recipients. [ Time Frame: During the donation/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: | 375 |
| 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 |
| 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
- Age 18 or older at the time of consent
- Has had a living donor identified and accepted and LDLT is planned
- Informed consent obtained
- Is listed for single organ (liver) transplantation
Donors
- Age 18 or older at the time of consent
- Has undergone donor evaluation process and was accepted and donation surgery is planned
- Informed consent obtained
Exclusion Criteria:
None
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01619475
Contacts
| Contact: Peg Hill-Callahan, BS, LSW | 734-369-9674 | Peg.Hill-Callahan@ArborResearch.org |
| Contact: Tania Chowdhury, MS | 734-369-9365 | Tania.Chowdhury@ArborResearch.org |
Locations
| 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: Megan A Brocato 303-724-1876 megan.brocato@ucdenver.edu | |
| Principal Investigator: Greg T. Everson, MD | |
| United States, Illinois | |
| Northwestern University, Division of Transplantation | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Patrice Al-Saden 312-694-0232 palsaden@northwestern.edu | |
| Principal Investigator: Michael M. Abecassis, MD, MBA | |
| United States, Massachusetts | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: Agnes Trabucco 781-744-3367 Agnes.Trabucco@Lahey.org | |
| Principal Investigator: Elizabeth Pomfret, MD | |
| United States, New York | |
| Columbia University | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Tarek Mansour 212-305-3839 tm2598@columbia.edu | |
| Principal Investigator: Jean C Emond, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Debra McCorriston 215-662-2107 debra.mccorriston@uphs.upenn.edu | |
| Principal Investigator: Kim M. Olthoff, MD | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Stephenie M Dermont 412-864-3781 kiklas@upmc.edu | |
| 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 jldavis4@vcu.edu | |
| Principal Investigator: Robert A. Fisher, MD | |
| Canada, Ontario | |
| 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 | |
Sponsors and Collaborators
Monique Lowe
Investigators
| Study Chair: | Robert M Merion, MD | University of Michigan Health System |
| Study Director: | James E. Everhart, MD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
More Information
Additional Information:
Publications:
| Responsible Party: | Monique Lowe, Data Coordinating Center Project Coordinator, 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: | July 25, 2012 |
| 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 Hepatitis A Hepatitis C Liver Cirrhosis Fibrosis Liver Diseases Liver Neoplasms Carcinoma, Hepatocellular End Stage Liver Disease Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Pathologic Processes Digestive System Neoplasms Neoplasms by Site Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Failure Hepatic Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013