Clinical trial · Observational
Adult-to-Adult Living Donor Transplant Cohort Study
A2ALL: Adult-to-Adult Living Transplant Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| End Stage Liver Disease | — | UNRESOLVED | — |
| Hepatitis C | — | UNRESOLVED | — |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Prospective
- description
- Individuals approved as liver donors and recipients shortly Pre-donation/Pre-transplant at the study sites.
- label
- Long-Term Follow-up
- description
- 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.
- label
- HCV-Infected Liver Transplant Recipients
- description
- 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).
Primary outcomes (7)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: None
References
Publications (35)
- BACKGROUNDOlthoff 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. doi: 10.1097/01.sla.0000179646.37145.ef. PMID 16135918
- BACKGROUNDFreise 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. PMID 18976306
- BACKGROUNDTrotter 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. doi: 10.1097/01.tp.0000263343.21714.3b. PMID 17565325
- BACKGROUNDTrotter 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. doi: 10.1002/hep.21845. PMID 17668879
- BACKGROUNDTerrault 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. doi: 10.1002/lt.20995. PMID 17192908
- BACKGROUNDFisher 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. doi: 10.1111/j.1600-6143.2007.01802.x.