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Brief Description
of the Collaboratory :
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Liver transplantation is the only cure for end stage liver disease. Each year, almost 4,500 people receive livers from deceased donors, but at least 18,000 individuals in the U.S. remain on the waiting list. Adult to adult living donor liver transplantation (AALDLT), where the donor receives a portion of a whole liver from a living donor, is one remedy that holds promise for saving more lives. Living donor liver transplantation is possible because the liver, unlike any other organ in the body, has the ability to regenerate. The technique of transplanting part of a liver was developed about 15 years ago as a way to transplant a portion of an adult-sized liver in a child. Medical advances have made it possible to do the same for adults. Physicians, patients, and potential donors need information to help them understand the risks and benefits of this relatively new procedure. The primary goal of the Adult to Adult Living Donor Liver Transplantation Cohort Study (A2ALL) is to follow sufficient numbers of patients being considered for and undergoing AALDLT and to provide generalized data on the outcomes.
The Adult to Adult Living Donor Liver Transplantation Cohort Study is comprised of nine geographically distributed transplant centers and the Data Coordinating Center (DCC) at the University of Michigan. The collaborating institutions were brought together through their individual selection by NIH and not through a joint proposal. Transplant centers were selected based on their scientific capabilities and on their experience with the procedure. Once they got together, the study investigators established two main protocols to standardize their research efforts. The retrospective protocol gathers data on transplants and donations that occurred at the centers in the past. Most of this data has now been collected, analyses are underway, and some results have been presented at national meetings. The prospective cohort study, which is scheduled to last until 2009, is collecting data on recipients of living donation and on potential living donor recipients who had a living donor evaluated but did not go through with the living donor transplantation. The evaluation and follow-up of liver donors is a key focus of the study. This includes analysis of the adequacy of informed consent, short- and long-term complications of the donor surgery, and long-term tracking of general health, quality of life, and personal and psychological effects of liver donation.
The research in A2ALL is performed by work groups organized around specific topics. The groups are comprised of individuals with expertise in these areas along with one member from the DCC. Additionally, each transplant center has a study coordinator--often a nurse--who is responsible for gathering, entering, and recording data. Study data are entered into an online system called BioDBx, which was developed at the University of Michigan. Physical samples are tracked by the DCC, but they are stored in an NIH-wide sample repository.
Ancillary studies provide opportunities to use the data and physical samples collected by A2ALL to address other research questions. There studies are conducted by A2ALL in conjunction with one or more non-A2ALL investigators or outside A2ALL by one or more non-A2ALL scientists. Funding for ancillary studies is obtained from sources beyond that provided by A2ALL, such as pharmaceutical companies or NIH.
The A2ALL project is managed by an 11-member Steering Committee (SC), which is comprised of the NIH Program Officer, PIs from each of the nine transplant centers, and the PI for the DCC, who was elected by the other SC members to serve as the Chair. Two of the transplant center PIs serve as co-chairs. The SC runs the project and makes most of the major decisions. During the first year of the project, the SC met face-to-face every eight weeks and held conference calls in between the meetings. Work groups report their progress to the SC. The Project Executive Committee, which consists of the chair and co-chairs, the NIH project officer, and the project biostatistician, deal with the day-to-day activities of A2ALL. This group meets weekly via a conference call.
The DCC developed a web-accessible collaboration environment to facilitate the work of A2ALL. Project documents, meeting schedules, study protocols, measurement instruments, publication guidelines, and a project directory are some of the resources available to A2ALL participants. The SC also uses the system for voting.
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