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Clinical Interventions
to Increase Organ Procurement
(FY 2002 - FY 2009)
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 is 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
will draw from three data sources: donor characteristics,
histopathology, and pulsatile perfusion. The study is
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 is intended to determine the accuracy
of echocardiography in donor evaluation and to evaluate
the efficacy of aggressive donor management. Outcomes
will be determined by organ utilization rates, donor
ejection fraction, and 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 is 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 will 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 is 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 will
be 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
proposes 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 is 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. |
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 will validate identification criteria that will
accurately recognize potential donors after cardiac
death (DCD). It will also look at post transplant data
from DCD donors and validate the current criteria being
used in regard to DCD donors. Study personnel will identify
patients who are undergoing withdrawal of life sustaining
treatments (LST) and obtain demographic characteristics,
physiological data, note 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 will test whether marginal pancreata from non-heart
beating cadaveric donors with long ischemic times and
whose age is greater than fifty can be utilized for
clinical islet transplantation. The proposed project
includes 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 will establish
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 is to determine whether short-term
attenuation of the inflammatory response using CytoSorb
can reduce pre-explanation organ dysfunction and thereby
improve organ recovery in brain-dead organ donors. The
goals of the project are 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 is to establish the efficacy of
continuous hypothermic machine preservation (HMP) in
liver transplantation. The hypothesis is that HMP will
increase the utilization of existing cadaver livers
by improving pretransplant 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 intends to increase 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 will be collected. Outcome measures of
waiting mortality and waiting time will be compared
to local data contained within the program transplant
database and compared with national data contained within
the SRTRD |
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 will implement 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 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 an 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 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. 3 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: |
Univ 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 ICU's 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 2009 Grantees
| Grantee: |
Regents of the University of Michigan |
| Grant
#: |
R38OT15492 |
| Consortium
Members: |
University of Michigan, Henry Ford Health System, Spectrum Healt-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
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