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Clinical Interventions to Increase Organ Procurement (FY 2002-FY 2011)

Fiscal Year 2011 Grantees

Grantee:The Regents of the University of California, San Francisco
Grant #:R38OT22183
Consortium Members:OneLegacy, California Transplant Donors Network, Cedars-Sinai Medical Center
Project Title:The Effect of Therapeutic Hypothermia on Deceased Donor Renal Graft Outcomes – a Randomized Controlled Trial from the Region 5 Donor Management Goals Workgroup
Description:Active medical interventions tested prospectively, in order to protect donor organs, hold great potential to decrease the organ supply-demand          imbalance. Such studies remain rare.  Additionally, compliance with pre-defined donor goals to stabilize the physiologic functions of donor organs remains low across different donation service areas (DSA) despite evidence that these protocols may improve organ yield. The goals of the proposal are to demonstrate that the following two interventions can improve allograft function and survival: (1) therapeutic hypothermia as an active medical intervention for the Neurologic Death Donor, and (2) compliance with DMG’s. These goals are to  be accomplished by bringing together a  research network extending over several DSA’s and using the power of the network to conduct a  prospective randomized single blinded trial hypothesizing that therapeutic hypothermia applied to a neurological determination of death donor is renal protective.
 
Grantee:University of Medicine and Dentistry of New Jersey
Grant #:R38OT22184
Consortium Members:University of Texas Health Sciences Center at San Antonio
Project Title:Remote Ischemic Preconditioning in deceased Organ Donors
Description:Interventions that have the potential to either increase the number of transplantable organs and/or improve the function of transplanted organs may decrease organ donor supply-demand imbalance. Brief periods of skeletal muscle limb ischemia via remote ischemic preconditioning (RIPC) may induce protection against prolonged ischemia in distant organs via production of anti-inflammatory, anti-oxidant and anti-apoptotic compounds which counteract the inflammatory mediators released in brain death. The goals of the clinical trial are (1) to show that RIPC induced soon after neurological determination of death (NDD),  and consent for donation, increases the number of organs recovered and transplanted per donor; (2) to demonstrate that RIPC implemented soon after neurological determination of death (NDD) improves circulatory stability, renal, myocardial and pulmonary function as well as perfusion parameters in machine preserved kidneys from those donors; and (3) to show that RIPC would improve early post transplant clinical outcomes in recipients of NDD organs.

Fiscal Year 2009 Grantees

Grantee:Regents of the University of Michigan
Grant #:R38OT15492
Consortium Members:University of Michigan, Henry Ford Health System, Spectrum Health-Butterworth Hospital
Project Title:Evaluation and Expansion of the use of Extracorporeal Life Support (ECS) for Controlled Organ Donation Following Cardiac Death
Description:Extracorporeal Life Support is felt to be a promising solution to the logistical issues of Donation after Circulatory Death (DCD) with the potential to improve outcomes by limiting ischemia and possibly resuscitating organs. The investigators hope to define the advantage that ECS offers over conventional DCD organ recovery and refine the procedure so that it can be used at hospitals lacking ECS programs. Aims include: 1. to determine organ yield transplanted per donor for ECS-DCD donors compared to rapid recovery DCD and Donation after Brain Death (DBD), 2. to compare outcomes of livers and kidneys transplanted from ECS-DCD donors to rapid recovery DCD and DBD donors and 3. to compare potential donor family as well as healthcare worker perceptions and attitudes to ECS-DCD versus rapid recovery DCD and DBD

Grantee:Cleveland Clinic Foundation
Grant #:R38OT15491
Consortium Members:Cleveland Clinic, Lifebanc
Project Title:Enhancing Donor after Circulatory Death (DCD) Utilization with Thrombolytic Therapy
Description:The investigators intend to evaluate approaches to DCD procurement utilizing the thrombolytic agent tissue plasminogen activator (rTPA) given the hypothesis that modulation of intravascular thrombosis by the use of rTPA will improve DCD kidney and liver function and prognosis. Although clinical outcome is the most important endpoint, testing will be performed to validate objective, verifiable and replicable laboratory measurements that may shed light on the mechanistic effect of these interventions


Fiscal Year 2008 Grantees

Grantee:University of Pittsburgh Medical Center
Grant #:R38OT10587
Consortium Members:University of Pittsburgh and nine Organ Procurement Organizations
Project Title:Monitoring Organ Donors to Improve Transplantation Results (MOnIToR)
Description:Fifty percent of organ donors are under fluid resuscitated after brain death. These donors have been previously demonstrated to have a higher inflammatory response and donate fewer organs. Plans involve a large multicenter study of 960 brain dead organ donors to protocolize resuscitation with a continuous hemodynamic monitoring platform or usual care. Three objectives: 1) conduct trial and test whether protocolized care improves number of organs for transplantation; 2) measure IL-6 over time as a pro-inflammatory response marker and test whether protocolized resuscitation decreases IL-6; 3) test feasibility of protocol administration in the community hospital setting where the majority of organ donation occurs

Grantee:University of Texas Health Science Center at Houston
Grant #:R38OT10585
Consortium Members:Univ of Texas Health Science Center at Houston and Baylor College of Medicine
Project Title:Nutritional Status and Enteral Absorption Capability after Brain Death
Description:Improving nutritional status of potential donors after declared brain dead could favorably impact organ procurement. Preliminary work shows increase IL-6 and TNF alpha in unfed donors and a correlation with improved graft survival in recipients with a lower IL-6. Half of a group of 36 donors are to be randomized to nutritional supplement. Through improved organ function and/or suppression of inflammatory cytokine production more organs are expected to be appropriate for procurement/transplantation and the risk of rejection reduced.

Grantee:Regents of University of California, San Francisco
Grant #:R38OT10586
Consortium Members:University of California, San Francisco
Project Title:Intensive Insulin Therapy in Deceased Donors-to Improve Renal Allograft Function and Transplanted Allograft Outcomes
Description:Intensive insulin therapy after neurological determination of death should decrease kidney injury and improve renal function at time of recovery. Previous retrospective analysis revealed hyperglycemia in Donation after Neurological Determination of Death (DNDD) is associated with decreased terminal renal function. Intensive insulin Rx (ITT) in ICUs are reported to be renal protective compared to standard Rx. The investigators plan a prospective observational study to measure impact of ITT on acute kidney injury in DNDD and allograft function in recipients and correlate evaluated biochemical markers of kidney function and health to develop more refined methods of predicting transplant success.

Grantee:Trustees of Columbia University in the City of New York
Grant #:R38OT10588
Consortium Members:Columbia University
Project Title:Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation
Description:Establish efficacy of continuous hypothermic machine preservation (MP) in transplantation of Extended Criteria Donor (ECD) livers. The investigators hypothesize this will increase utilization of existing ECD cadaver livers by increasing preservation, quality and improving early graft function. Outcome measures include: 1) graft survival at 30, 60, 90 days and 1 year, 2) preservation injury via graft histology, ultrastructure and serum markers of early graft function, 3) vascular and biliary complications and 4) ICU and hospital length of stay. Outcomes will be compared to 24 historical controls who received livers preserved with cold storage techniques.


Fiscal Year 2007 Grantees

Grantee:University of Pittsburgh
Grant #:R38OT08758
Consortium Members:University of Pittsburgh, Center for Organ Recovery and Education, University of Michigan Gift of Life
Project Title:Development and Dissemination of a Rapid Response System for Uncontrolled Donation after Cardiac Death (UDCD)
Description:This project will create a program to successfully implement organ transplantation from uncontrolled donation after cardiac death donors and demonstrate the ability to rapidly disseminate a UDCD program to another institution.

Grantee:New York City Health and Hospitals Corporation
Grant #:R38OT08761
Consortium Members:New York City Health and Hospitals Corporation, New York Organ Donor Network, New York University School of Medicine, New York City Emergency Medical Services
Project Title:Opportunities for Organ Donation: Expanding the Right to Donate Organs Following Uncontrolled Circulatory Determination of Death
Description:This project is based upon the sparse organ donation opportunities to date for pre-hospital uncontrolled donation after cardiac death (UDCD). A consortium of Bellevue Hospital Center, the New York City Emergency Medical Services and The New York Organ Donor Network propose to enhance public and professional education, disseminate best practices, and monitor and evaluate donation efforts from UDCD while adding preparation for organ donation to the end of standard cardiac resuscitation protocols


Fiscal Year 2004 Grantees

Grantee:Carolina Donor Services
Grant #:R38OT03593
Consortium Members:Carolina Donor Services, University of Carolina, Chapel Hill
Project Title:Ex-Vivo Evaluation of Human Lungs from Non-Heart Beating Donors for Transplant
Description:This project implemented an established system to perfuse and ventilate human lungs ex-vivo, to assess gas exchange and other parameters of function of lungs retrieved from non-heart beating donors


Fiscal Year 2003 Grantees

Grantee:University of Pittsburgh
Grant #:R38OT01243
Consortium Members:University of Pittsburgh School of the Health Sciences, Children's Hospital of Pittsburgh, UPMC Presbyterian Hospital, UPMC Shadyside Hospital, University of Cincinnati, Case Western Reserve University
Project Title:Donors after Cardiac Death Validating Identification Criteria
Description:This project planned to validate identification criteria that accurately recognize potential donors after cardiac death (DCD). It also examined post-transplant data from DCD donors and validated the current criteria being used in regard to DCD donors. Study personnel identified patients who were undergoing withdrawal of life-sustaining treatments (LST) and obtained demographic characteristics, physiological data, noted the type of LST being delivered and withdrawn as well as the palliative medication delivered.

Grantee:University of Miami
Grant #:R38OT01367
Consortium Members:University of Miami-Diabetes Research Institute, Medical College of Georgia, New Jersey Organ and Tissue Sharing Network, Lifepoint, Inc., Translife
Project Title:The Use of Perfluorinated Hydrocarbons during Pancreas Procurement to Improve Utilization of Cadaveric Marginal and Non-Heart Beating Donor Organs for Clinical Islet Transplantation
Description:This project tested whether marginal pancreata from non-heart beating cadaveric donors with long ischemic times and whose age is greater than fifty could be utilized for clinical islet transplantation. The proposed project included the training of OPO collaborators in this methodology for the preservation and transport of perfluorocarbon (PFC)—cultured pancreata utilizing sufficient organs to establish significance. The field-testing of this intervention at collaborating OPO centers established replicability of the procedure on a larger scale.

Grantee:University of Pittsburgh
Grant #:R38OT1300
Consortium Members:University of Pittsburgh, University of Texas at Houston, LifeGift, CORE
Project Title:Hemoadsorption to Improve Organ Donor Recovery
Description:This purpose of this grant was to determine whether short-term attenuation of the inflammatory response using CytoSorb could reduce pre-explanation organ dysfunction and thereby improve organ recovery in brain-dead organ donors. The goals of the project were to reduce circulating cytokine levels in potential organ donors, improve organ function in those donors and to increase organ recovery per donor.

Grantee:Trustees of Columbia University
Grant #:R38OT01301
Consortium Members:Columbia University
Project Title:Hypothermic Machine Preservation of Liver Grafts for Transplantation
Description:The aim of this project was to establish the efficacy of continuous hypothermic machine preservation (HMP) in liver transplantation. The hypothesis stated that HMP would increase the utilization of existing cadaver livers by improving pre-transplant assessment of the graft, increasing the quality of preservation, and permitting ex situ pharmacologic manipulation.

Grantee:The Children's Hospital
Grant #:R38OT01314
Consortium Members:The Children's Hospital, Denver, Donor Alliance
Project Title:Infant Heart Transplantation from Non-Heart Beating Donors: A Strategy to Reduce Waiting Mortality
Description:This project intended to increase the number of infant cardiac donors as a way to reduce waiting time and waiting mortality by implementing a non-heart beating donor protocol for cardiac donation in infants and children. Data from the population of patients receiving a donor organ from a non-heart beating donor and from a traditional heart beating donor were collected. Outcome measures of waiting mortality and waiting time were compared to local data contained within the program transplant database and compared with national data contained within the SRTRD


Fiscal Year 2002 Grantees

Grantee:The Johns Hopkins University
Grant #:1H39OT0013301
Consortium Members:The Johns Hopkins University Departments of Surgery, Medicine and Pathology
Project Title:Enhanced Utilization of Extended Criteria Donor Kidneys
Description:The goal of this project was to identify criteria that have predictive value for the performance of extended criteria donor kidneys after transplantation and validate a model for evidence-based selection of viable organs. The criteria drew from three data sources: donor characteristics, histopathology, and pulsatile perfusion. The study was designed to answer fundamental questions about the value of pulsatile perfusion in resuscitating, preserving, and interrogating the function of both high- and low-risk extended criteria donor kidneys.

Grantee:Health Services Foundation
Grant #:1H39OT0013501
Consortium Members:University of Alabama at Birmingham, University of California, San Francisco, Life Connection of Ohio
Project Title:Multi-center Trial to Increase Recovery of Donor Organs through Improved Evaluation of Donor Hearts and Aggressive Donor Management
Description:This multi-center trial was intended to determine the accuracy of echocardiography in donor evaluation and to evaluate the efficacy of aggressive donor management. Outcomes were determined by organ utilization rates, donor left ventricular ejection fraction, cardiac output and left ventricular stroke work.

Grantee:New England Organ Bank
Grant #:1H39OT00123-01
Consortium Members:New England Organ Bank, University of Michigan, Gift of Life Michigan, Life Choice Donor Services
Project Title:The Impact of an Expedited Allocation System and Pulsatile Preservation upon the Transplantation of Kidneys from Expanded Criteria Donors
Description:The purpose of this project was to increase the number of kidneys transplanted from expanded criteria donors and determine whether specific pre-transplant characteristics of expanded donor kidneys and the recently adopted OPTN expedited allocation system would influence kidney acceptance rates, reduce discard rates, and increase the opportunity for kidney transplantation.

Grantee:Indiana Organ Procurement Organization
Grant #:1H39OT00134-01
Consortium Members:Indiana Organ Procurement Organization, the Ohio State University, Grant Medical Center, Metrohealth, the Aultman Health Foundation, Parkview Hospital, Methodist Hospital, Clarian Health
Project Title:Effectiveness of High-Frequency Chest Wall Oscillation to Improve the Quantity and Quality of Brain-dead Heart-beating Donor Lungs Recovered for Transplantation
Description:The purpose of this experimental study was to critically evaluate the effect of adding high-frequency chest wall oscillation to the routine donor management protocol in the care of brain-dead heart-beating donors. The outcomes of quantity and quality of donor lungs were evaluated.

Grantee:University of Miami
Grant #:6H39OT00126-01-01
Consortium Members:University of Miami, University of Miami Organ Procurement Organization
Project Title:Donor Treatment with "The Link™" to Improve Airway Clearance and Increase the Number of Lungs Recovered for Transplantation
Description:Application proposed to treat organ donor patients during donor management with "The Link™," a device using an inflatable vest to deliver oscillating compressive forces over the chest to dislodge mucous and secretions in donor lungs. This intervention expected to improve donor airway clearance; improve lung function as measured by objective parameters; and increase the yield of donor lungs recovered for transplantation, as compared to donors in the non-intervention group.
 


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