What is PUMP?
PUMP is first, and foremost, an international data registry for livers that are perfused. This is an unmet need in the transplant community. PUMP has the capacity to be even more.
Where is the database kept?
Data will be maintained in an IRB approved database by the Department of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai. Mount Sinai has engaged a vendor called “Studypages” to store the data on its behalf.
What is Studypages?
Studypages is a secure web-based software platform utilized by academic medical centers, and patient- and research organizations. Studypages has been engaged by the PUMP consortium as their technology vendor.
PUMP will leverage Studypages’ cutting-edge mobile and desktop transplant application for every participating liver transplantation center globally. This innovative tool will collect deep data on livers for transplantation, creating a valuable data registry for future research studies.
Who can join PUMP?
All liver transplant centers perfusing livers are eligible to join PUMP. Centers with experience perfusing at least 10 livers may be eligible for financial support (see below).
What happens after my center registers?
Registering will be followed by an acknowledgement email and a short survey. Study documents (including documents needed for IRB approval) and contracts will then be sent. Once on-boarding has occurred, centers will be able to individualize their data capture to include the standard elements as well as any other elements they may want to contribute to the database. Centers will be encouraged to collect their data and then can share with PUMP once the contracts and study approvals are in place.
What data will be collected?
Data collection will be relevant to recipient and donor characteristics as well as perfusion metrics and lab results. No surgeon or center-specific information will be made available except to the center itself and Mount Sinai as the primary manager of the registry.
Can participating centers share their data elsewhere?
Yes. There is no exclusivity requirement.
Which cases can be included in the registry?
All pumped cases, regardless of which device is used and including hypothermic and normothermic perfusions as well as regional perfusion cases can be included. Transplanted as well as discarded livers will be included. Research will be designed to help determine which viability criteria are most predictive of success, both independently and in multivariate analyses.
Who has access to my program’s data?
Centers will have unrestricted, protected access to their own data at all times. Participants will have access to aggregated de-identified data from all cases within the database. Data requests and publications will be overseen by the Executive Committee. Publications will include all participating centers according to standard guidelines for consortium publications.
What does it cost to be involved with PUMP?
Centers will not incur any costs. PUMP is an initiative created by the Recanati/Miller Transplantation Institute at Mount Sinai and is supported, in part, by the generosity of the Blavatnik Family Foundation. Approved centers may receive financial support for regulatory submissions as well as support for data collection and entry.