A Study to Compare the Effects of Liver Preservation for Transplant via Normothermic Machine Perfusion, versus Static Cold Storage
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-007330
NCT ID: NCT02775162
Sponsor Protocol Number: WP01
About this study
The purpose of this study is to compare the effects of normothermic machine profusion versus static cold storage for preventing preservation-related graft injury in human livers for transplantation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 18 years of age or greater
- Registered as an active recipient on the UNOS waiting list for liver transplantation
- Subject, or legally authorized representative, is able and willing to give informed consent and HIPAA authorization
- Able and willing to comply with all study requirements
Exclusion Criteria
- Requires all of the following at the time of transplantation
- Oxygen therapy
- Inotropic support
- Has acute/fulminant liver failure
- Is undergoing simultaneous transplantation of more than one organ
- Is pregnant or nursing
- Concurrent enrollment in another clinical trial.
- Enrollment in clinical trials or registries where only measurements and/or samples are taken (NO TEST DEVICE or TEST DRUG USED) is allowed
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Andrew Singer, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available