Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096733
Status:
COMPLETED
Last Update Posted:
2017-08-29
First Post:
2004-11-12
Brief Title:
Adult-to-Adult Living Donor Liver Transplantation Study
Sponsor:
Arbor Research Collaborative for Health
Organization:
Arbor Research Collaborative for Health
Study Overview
Official Title:
Adult-to-Adult Living Donor Liver Transplantation Cohort Study
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A2ALL-1
Brief Summary:
There are two principal purposes of this study 1 to determine whether it is more beneficial for a liver transplant recipient candidate to pursue a living donor liver transplant LDLT or wait for a deceased donor liver transplant DDLT and 2 to study the impact of liver donation on the donors health and quality of life
Detailed Description:
Adult to adult living donor liver transplantation LDLT is a relatively new procedure increasingly used at major transplantation centers Relatively small numbers of cases are performed at any one center and approaches to the patient and donor are too diverse across centers to provide reliable and generalizable information on donor and recipient outcomes from individual centers Therefore a network of nine leading liver transplantation centers and a data coordination center DCC has been organized to accrue and follow sufficient numbers of patients being considered for and undergoing LDLT to provide generalizable results from adequately powered studies This network has established the Adult to Adult Living Donor Liver Transplantation Cohort Study A2ALL that will conduct both retrospective and prospective studies of LDLT
The primary study objective is to analyze the effect of choosing to pursue living liver donation The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated at least a history and physical examination Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant Finally a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure
Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT
The primary study objective is to analyze the effect of choosing to pursue living liver donation The principal hypothesis is that pursuit of a living liver allograft leads to decreased pre-transplant morbidity and mortality and better long term outcomes for patients starting from the point at which listed patients have a potential donor evaluated at least a history and physical examination Emerging data suggest that LDLT provides an inferior graft because of reduced parenchymal mass and added technical complexity when compared to a whole liver used for DDLT The magnitude of the disadvantage to the LDLT graft will be assessed by comparing results between LDLT and DDLT from the time of transplant Finally a careful and detailed series of studies of potential and actual living liver donors is included as a primary objective because of the tremendous importance of this issue to our understanding of the impact of the procedure
Secondary objectives will address selected biological and clinical issues in transplantation structured around the comparison between DDLT and LDLT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DK062498-01 | NIH | None | httpsreporternihgovquickSearchU01DK062498-01 |