John A. Kellum, M.D., associate professor of critical care medicine, will receive a total of $947,925 to evaluate whether an experimental device can help improve the quality of organs in brain-dead donors before they are removed for transplantation. Michael DeVita, M.D., associate professor of critical care medicine and medicine, will receive $578,911 over the next three years to conduct a study that aims to help hospitals and organ procurement organizations (OPOs) better identify donors after cardiac death.
The two Pitt grants are among 13 awarded by HHS. Eight grants were awarded through the HHS program, Social and Behavioral Interventions to Increase Organ and Tissue Donation, and five, including the two Pitt grants, were awarded through HHS's Clinical Interventions to Increase Organ Procurement. These grants seek to evaluate clinical interventions that have the potential to increase the number of organ donors and the number of organs recoverable from existing donors.
Study looks at device's potential for improving organ quality.
About half of all organ donors in the United States are deceased donors, the vast majority of whom are declared brain dead before their organs are donated and removed. While not completely understood by researchers, the process of brain death itself can compromise the quality and function of organs before they are even removed. After brain death, an unknown process triggers cells to release certain molecules called cytokines as part of a massive inflammatory response. CytoSorbÔ is an experimental device that Dr. Kellum and colleagues will evaluate in donors to determine its ability to absorb these circulating cytokines before they invade tissue and impair organ function. Its main component is a cartridge containing millions of beads made of a special polymer that is designed to remove cytokines from the blood stream. A similar device made by the same manufacturer, RenalTech International, LLC, is being tested as an accessory to hemodialysis in patients with kidney failure.
By the end of the three-year study, the researchers hope to have observed 114 potential and actual donors who have been treated with the device before organ recovery. The researchers also will follow an estimated 225 recipients who receive organs from 60 of these donors. If the device proves effective, the team anticipates more organs per donor will be deemed viable for donation and transplantation and that graft function in recipients who receive organs from donors treated with the device will be improved.
Two medical centers and two organ procurement organizations are participating in the study: the University of Pittsburgh Medical Center (UPMC); the University of Texas at Houston; and the Center for Organ Recovery and Education (CORE), the OPO serving western Pennsylvania, West Virginia and an area in southern New York; and the LifeGift Organ Donation Center in Houston.
Study aims to increase donors after cardiac death.
Compared to brain-dead donors, donors after cardiac death represent a very small subset of the total number of deceased donors. According to the most recent data from the U.S. Scientific Registry of Transplant Recipients, 167 of the 6,081 deceased donors in 2001 were from donors after cardiac death, also referred to as nonheart-beating donors. Dr. DeVita and colleagues hope that by validating criteria used to identify donors after cardiac death, the process will become more standardized and more OPOs will engage in the procurement of organs from such donors, helping to expand the overall size of the donor pool.
The study also may help to identify the real and perceived obstacles to increasing the number of donors after cardiac death and provide a method that will allow transplant outcomes using organs from these donors to be compared in a more uniform and meaningful fashion.
The researchers will collect data on 500 critically ill intensive-care patients who are undergoing withdrawal from life-sustaining treatment. Participating sites are UPMC (UPMC Presbyterian, UPMC Shadyside and Children's Hospital of Pittsburgh) and the University Hospitals of Cleveland. CORE and the Epidemiology Data Center at the University of Pittsburgh Graduate School of Public Health are collaborators as well.
According to the United Network for Organ Sharing, there are more than 82,000 patients currently awaiting organ transplants in the United States. In 2002, 6,187 individuals died on the U.S. organ transplant waiting list because the organ they needed was not donated in time.