Deceased Donor Kidney Storage at 10 Celsius Versus Conventional Storage
Phase: NA
Conditions: End Stage Chronic Renal Failure, Chronic Kidney Disease (Stages 4 and 5), Kidney Transplantation Recipients
Sponsor: Vanderbilt University Medical Center

Revision Date: Dec 5 2025 
Protocol Version #:  2 
  
  
  
  
  
  
  
  
  
  
  
  
Deceased Donor Kidney  
Storage at 10 Celsius versus 
Conventional Storage  
                    
Christian Crannell, MD*; Rachel Forbes, MD, MBA; Peter Reese, 
MD, Ciara Shaver, MD, PhD; Matthew Bacchetta, MD  
 
* Principal investigator 
 
 
  
  
  
  
  
  
  
  
 
  

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PROPOSED RESEARCH PLAN—Summary  
  
Protocol Overview:   
 
Study Description  
Based on preliminary clinical safety studies, and animal findings 
of improved ex-vivo kidney function after 10°C storage 
compared to conventional storage on ice, the aim of this study 
is to translate static storage at 10°C to clinical practice in kidney 
transplantation.  
Primary Outcomes: 
1. Store pre-procurement deceased donor kidneys in the 
X°Port Lung Preservation System from the time of 
procurement until transplantation at Vanderbilt University 
Medical Center (VUMC) and evaluate recipient kidney 
allograft function by measuring urinary neutrophil 
gelatinase-associated lipocalin (NGAL), which is a 
biomarker for acute kidney injury associated with DGF.   
2. Compare recipient outcomes between kidneys which 
were stored using the X°Port Lung Preservation System 
vs those stored on ice.  
a. Primary outcome is urinary NGAL level.   
Secondary Outcomes: Recipient urine output measurements, 
serum creatinine levels, the presence of DGF, and the 
recipient’s 30-day creatinine and estimated glomerular filtration 
rate. 
The goal of this study is to compare the outcomes of recipients 
who received kidneys preserved using the X°Port Lung 
Preservation System to control recipients who received kidneys 
preserved at static cold storage on ice.   
It is a prospective, double-arm, open-label, single-center study. 
Kidneys will either be preserved with the investigational device 
or with static cold storage on ice. This research aims to optimize 
static preservation of kidney allografts as an accessible strategy 
to improve outcomes. 
Study Population: 
All adult single organ kidney transplant candidates on the 
waiting list at the study center will be eligible for enrollment. 
Both donation after brain death and donation after circulatory 
death kidney donors will be included in this study. Recipients 
must be 18 years old or older, must have given consent for the 
study, and must be listed for a single organ kidney 
transplantation.   
Planned Sample Size:  
 30 in the intervention arm  
Participating 
Institutions (if a multi-
center clinical trial) 
n/a (single-center trial) 

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Background and Rationale:   
Kidney transplantation is a life-saving treatment for patients with end stage kidney disease, which affects nearly 
800,000 patients in the United States. However, deceased donor kidney transplantation is often complicated by 
delayed graft function (DGF), conventionally defined as the recipient requiring hemodialysis within the first 
week after transplant. DGF is unfortunately common, occurring in 25% of all transplanted kidneys and portends 
worse long-term graft survival, higher rates of rejection, and increased recipient mortality. DGF commonly 
occurs because of ischemic reperfusion injury (IRI), a complex pattern of injury occurring at the time of organ 
procurement. IRI results from decreased cellular ATP, decreased function of the Na/K pump, mitochondrial 
destabilization, the generation of reactive oxygen species (ROS), apoptosis, complement and immune cell 
activation. Most commonly, kidneys and other deceased donor organs have been stored on ice to minimize 
cellular oxygen consumption and prevent IRI. However, preliminary data show that porcine kidneys are 
exposed to high levels of ROS when stored on ice due to decreased mitochondrial protective pathways 
associated with hypothermic conditions. Promising studies in other organ systems demonstrate reduced ROS 
when organs are stored at 10°C instead of standard ice. In lung transplant, porcine lungs stored at 10°C vs 
standard ice show better physiologic metrics, decreased mitochondrial DNA release, less cell death, less 
lactate production, and less glucose consumption. Higher levels of protective mitochondrial metabolites were 
observed in lungs stored at 10°C than standard ice storage. These metabolites promote the innate anti-
oxidative system within mitochondria, protecting against ischemic injury. Clinically, human lung transplant 
shows favorable clinical outcomes with prolonged cold ischemia at 10°C vs ice storage. Within kidney 
transplant, there have been no similar investigations of 10°C storage compared to ice. We hypothesize that 
deceased donor kidney storage at 10°C will be superior to standard ice storage. This study has the 
potential to transform deceased donor organ storage and establish a new standard of care by storing kidneys 
at 10°C. Further, preserving kidney mitochondrial function and decreasing the rate of DGF, would allow 
transplant centers to accept more organs by lowering the clinical risk associated with organ acceptance, with 
an overall increase in organ utilization.   
  
  
Aims:   
1. Store pre-procurement deceased donor kidneys in the X°Port Lung Preservation System from the time 
of procurement until transplantation at Vanderbilt University Medical Center (VUMC) and evaluate 
recipient kidney allograft function by measuring urinary neutrophil gelatinase-associated lipocalin 
(NGAL), which is a biomarker for acute kidney injury associated with DGF.   
2. Compare recipient outcomes between kidneys which were stored in either the X°Port Lung 
Preservation System vs static cold storage on ice.  
a. Primary outcome is urinary NGAL level.   
b. Secondary outcomes: Recipient urine output measurements, serum creatinine levels, the 
presence of DGF, and the recipient’s 30-day creatinine level and estimated glomerular filtration 
rate 
There are 800,000 patients with end stage kidney disease and 96,000 patients waiting for a kidney 
transplant1. Kidney transplant remains life saving for these patients, but the need for organs dramatically 
exceeds the supply: 14 patients die each day while waiting for a kidney transplant,2 and 25% of all recovered 
deceased donor kidneys are discarded, a problem that has worsened over the past decade.2 When patients 
receive a transplant, it is complicated by DGF in 25% of kidney transplants.3 Research has shown that when 
patients experience DGF, they are at higher risk of hospital readmission, worse allograft function, rejection and 
mortality.3–6   
  
DGF arises in part from IRI to the graft that occurs at the time of organ procurement. Ischemic 
reperfusion is a complex pattern of injury that ultimately results in decreased cellular ATP, decreased function 
of the Na/K pump, lysosomal degradation, mitochondrial destabilization, generation of reactive oxygen species 
(ROS), apoptosis, and complement and immune cell activation. Mitochondrial ROS generation seems to have 

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a crucial role in the pathogenesis of renal IRI.7 It is believed that storing kidneys at 4°C on ice minimizes 
cellular oxygen consumption and minimizes IRI compared to normothermia; however, preliminary data show 
that cooling porcine kidneys on standard ice may be detrimental due to decreased mitochondrial 
protective pathways including ROS scavenging. 8 While there is decreased oxygen consumption with 
standard ice storage, there is a much less robust decrease in the generation of ROS.8 With standard ice 
storage, the amount of generated mitochondrial ROS is relatively high compared to the decreased oxygen 
consumption.8   
  
Storage at 10°C has been used for other organs. In lung transplant, porcine lungs stored at 10°C vs ice show 
better physiologic metrics, decreased levels of mitochondrial DNA release, less cell death, less lactate 
production and less glucose consumption.9 Higher levels of mitochondrial protective metabolites including 
itaconate, glutamine, and N-acetylglutamine were observed in lungs stored at 10°C than at on standard ice9. 
These metabolites promote the innate antioxidant system within mitochondria, protecting against ischemic 
injury.10. Clinically, human lung transplant shows no worse outcomes with prolonged storage at 10°C vs on ice, 
even with extended cold ischemia time.11 Porcine livers stored at 10°C vs on ice show better oxygen 
consumption when placed on subsequent normothermic perfusion system, with improved bile flow, less cell 
death and a better biochemical profile. 12 Preliminary porcine studies performed by Dr. Crannell show that 
deceased porcine kidneys stored at 10°C at 24 hours and reperfused on normothermic machine perfusion 
(Figure 1) have increased urine output, better oxygen consumption, improved vascular flow and lower 
hemodynamic resistance compared to porcine kidneys stored on standard ice (Figure 2, unpublished data).  
   
Within human kidney transplant, Dr. Crannell published a case report describing the successful kidney 
transplant of a 10°C-stored kidney13. From this work, we hypothesize that deceased donor kidney storage at 
10°C will be superior to conventional storage, with decreased levels of neutrophil gelatinase-associated 
lipocalin (NGAL), a urine biomarker for acute kidney injury that has been shown to be predictive of delayed 
kidney graft function.14,15  
 
Figure 1: Experimental overview of normothermic machine perfusion after static storage at 10˚ C or on ice for 24 
hours.  
 
 
 
 
 

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A:  
 
 
 
 
 
 
B:  
 
 
C:   
 
 
 
 
 
 
D:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 2: Porcine kidneys stored at 10°C for 24 hours and reperfused with normothermic machine perfusion 
(NMP) have better (A) total flow, (B) lower resistance, (C) have higher oxygen consumption and (D) make 
more urine compared to kidneys stored on ice. N=6 organs per study group 
 

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Inclusion / Exclusion Criteria   
Deceased donor inclusion criteria:   
1. Donation after brain death or donation after circulatory death kidney donors, whose health care proxy 
has consented for donation and the possibility of research    
2. Deceased donor kidneys that have been allocated to Vanderbilt University Medical Center (VUMC) as a 
primary match offer prior to organ procurement will be eligible   
  
Deceased donor exclusion criteria:  
1. Donors whose health care proxy has declined consent for the possibility of research   
2. Deceased donor kidneys that have been allocated to VUMC as a backup offer  
3. Deceased donor kidneys that have been allocated to VUMC as a post procurement offer   
4. Deceased donor kidneys that have already been placed on ice storage 
  
Patient (recipient) inclusion criteria   
1. All adult single organ kidney transplant candidates on the waiting list will be eligible for enrollment.   
  
Patient (recipient) exclusion criteria   
1. Kidney recipients less than 18 years old  
2. Kidney transplant candidates that decline consent  
3. Transplant candidates listed for multi-organ transplant  
  
  
Methods  
  
The proposed study is a prospective, double-armed, open-label, single-center trial. Once an organ offer is 
made to VUMC and reviewed for suitability, the kidney transplant recipient will be contacted by one of our 
research key study personnel (KSP), trained as kidney transplant organ coordinators to review the organ offer 
per standard operating procedure. Once the surgeon has accepted the organ offer, the coordinator will review 
the study with the patient using the phone script for informed consent.   
  
Organ storage groups: X°Port Lung Preservation System vs. Static Cold Storage (Ice)  
The study will test the difference between storage of donor kidneys in the X°Port Lung Preservation System 
(X°Port LPS) (experimental) and static cold storage on ice (standard of care). The storage method used will be 
determined by the location of the donor kidney because of study logistics (see below).  
  
If the donor kidney is coming from an organ procurement organization(s) (OPO) participating in the trial, the 
study organ coordinator will alert the on-site procurement team that the kidney is to be placed in the X°Port 
LPS. The organ coordinators have regular and frequent contact with the OPOs as part of the procurement and 
transplant process. If the donor kidney is outside of a participating OPO, no alert is required. These organs are 
automatically stored on ice.   
  
All donor kidneys will be obtained per standard clinical practice by the local procurement surgeon. After 
collection, the kidneys will either a) be placed in the X°Port LPS and stored at approximately 10°C or b) be 
stored on ice per standard of care procedures. Donor kidneys will be labeled with the anonymous United 
Network for Organ Sharing number and will be stored per UNOS policy in three layers of protection prior to 
being placed in the X°Port LPS.  
  
Biospecimen Collection:  

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Urine will be collected from the transplant recipient’s indwelling urinary catheter on the morning of 
postoperative day 1 (POD1), prior to initiation of the immunosuppressant tacrolimus. The samples will be 
processed, labeled with an anonymous study ID number and stored appropriately until further analysis.  
  
Data collection:  
Donor characteristics including age, body mass index (BMI), mechanism of death (anoxia, cerebrovascular 
accident, head trauma, unknown/other) type of donation (donation after brain death, donation after circulatory 
death, type of organ support (+/- normothermic regional perfusion), warm and cold ischemia times, kidney 
donor profile index, and terminal donor creatinine will be collected and recorded in REDCap. Recipient 
characteristics including age, sex, BMI, etiology of kidney disease, dialysis status prior to transplant (peritoneal 
dialysis, hemodialysis, or pre-emptive transplant) and major comorbidities will be collected in REDCap and 
analyzed. Post-transplant clinical measures including urine output, daily creatinine, estimated glomerular 
filtration rate (GFR), need for renal replacement therapy, creatinine at 30 days, eGFR at 30 days and death 
within 30 days will be recorded at the 1 month mark post-transplant.  
  
Primary endpoint:  
The primary study end point will be recipient urine NGAL level as measured in duplicate by ELISA and 
compared between recipients who received a kidney stored in the X°Port LPS versus those that were stored 
conventionally on ice.  
  
Secondary endpoints:  
Secondary outcomes will include recipient 24 h post op urine output measurements, daily serum creatinine and  
GFR, the presence of DGF, and the recipient’s 30-day creatinine level and eGFR. These clinical outcomes will 
be compared between recipients who received a kidney stored in the X°Port LPS versus those that were stored 
conventionally on ice.   
  
 
Consent  
Consent and eConsent process: 
For pre-procurement organ offers, eConsent will be performed as follows: One of our kidney transplant organ 
coordinators will ask if the patient would be interested in hearing about a research study for which they qualify. 
The coordinator will provide a brief summary about the study by phone. If the patient is interested in learning 
more, the coordinator will email him/her a printable copy of the consent to look over and set up a second 
phone call where they can review the document together. A link to the eConsent will be emailed to the patient 
at the start of the second phone call. The coordinator will review the entire document with the patient. He/She 
will be able to ask any questions, and sign the eConsent which will be returned through the REDCap system. 
Patients will be emailed a final signed copy of the consent document as a PDF for their records.  
 
If a patient is unable to complete an eConsent, an in-person written consent will be performed. The consent 
form will be scanned into REDCap, and the patient will be provided with their signed consent form after it is 
scanned. No paper consent will be retained by study investigators. 
  
Data and Safety Monitoring Plan  
Because the true risk of kidney storage at 10°C is unknown, we will also collect data on several safety 
endpoints including:   
    1. Graft function   
a. Immediate kidney graft function: urine output with immediate improvement in recipient creatinine  
b. Slow graft function: urine output without immediate improvement in creatinine  
c. Delayed graft function: recipient requiring hemodialysis within the first 7 days post-transplant   
2. Unanticipated transfer to the ICU   
3. NSTEMI/STEMI/CVA   

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4. Mortality within 30 days.  
  
The project will have a data safety monitor, Dr. Laura Hickman, a kidney transplant surgeon who routinely 
monitors kidney transplant clinical and quality outcomes. Data monitoring of the first 10 patients receiving the 
X°Port LPS stored kidney will be performed to determine if the trial meets all safety endpoints, and if the 
collection protocol meets all study needs.   
  
After the first 10 patients, data will be monitored monthly examining the following safety outcomes:  
• 
A statistically worse rate of delayed graft function (currently 24% at VUMC)  
• 
Perioperative NSTEMI/STEMI/CVA  
• 
30-day perioperative mortality attributed to the transplant  
• 
Primary non-function (defined as a return to dialysis within 3 months of kidney transplant)  
  
The following adverse events (AEs) will initiate a pause in enrollment to further assess the study’s efficacy and 
determine medical cause for the AE   
• 
More than 2 investigational study patient deaths within 30 days among the first 10 cases   
• 
A statistically worse rate of DGF   
  
Dr. Hickman and Dr. Crannell will meet monthly to discuss the data and safety monitoring. If any of the safety 
endpoints are met, the IRB will be promptly notified according to IRB policies and procedures. Interim  
analyses at 6 and 12 months will be performed to evaluate the safety and potential benefits of 10°C kidney 
storage.   
  
  
Statistical Methods 
Differences between donors and recipients of ice-stored organs vs X°Port LPS-stored organs will be compared 
by Mann Whitney U for continuous variables and Chi squared for categorical variables. To examine the 
relationship between storage temperature and the primary outcome NGAL level, a univariate linear analysis 
examining donor and recipient covariates will be performed, with a subsequent multivariable linear regression 
analysis controlling for relevant clinical variables including type of donation (DBD vs DCD), kidney donor profile 
index and terminal donor creatinine. Logistic regression will be used to compare categorical outcomes. A 
median difference will be calculated between NGAL levels for kidneys stored in the X°Port LPS vs those stored 
on ice. To calculate the sample size needed, the concept of conditional power (CP) was implemented, defined 
as the chance the study will be statistically significant at its planned end. Using Welch’s unequal-variance 
approach with a fixed 6:1 control-to-case ratio and an assumed between-group difference of 3,000 NGAL units 
(10C minus ice storage), it was determined that enrolling 11 cases and 66 controls provides an estimated 91 
percent chance of statistical significance. This study will enroll 30 patients to ensure power for the primary 
outcome, sufficient evaluation of secondary outcomes and a comprehensive assessment of the safety and 
effectiveness of 10˚C storage. 
 
Summary  
Organ storage has typically been done on ice in the hopes of minimizing IRI, but there is very good clinical data 
that this paradigm may not yield optimal donor organ performance. Indeed, there has been a shift in recent 
years and livers are now being maintained under normothermic machine perfusion16, lungs are being stored at 
10°C with good clinical outcomes9,11, and hearts have moved away from storage on ice17,18.  
Significantly, there has been no trial examining the effects of 10°C storage on the kidney. This study hopes to 
show the clinical benefit of 10°C storage for deceased donor kidney transplant, with lower biomarkers of acute 
kidney injury. Storage at 10°C is simple and more cost effective when compared to machine perfusion and has 

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obvious benefits for transportation simplicity and cost. This study has the potential to be very impactful and 
establish a new norm for deceased donor organ preservation temperature.   
  
Christian Crannell, MD is a kidney transplant surgeon at Vanderbilt University Medical Center interested in 
optimizing organ grafts and organ utilization. Most recently he has published on a successful 10°C kidney 
transplant. Additionally, he has published on the role of heparin in deceased donor procurements and the 
labelling effect of high kidney donor profile index kidneys. He is a member of Dr. Bacchetta’s Laboratory for 
Organ Regeneration, Recovery, and Replacement, which focuses on 10°C organ storage and perfusion 
systems. Dr. Crannell will be responsible for all aspects of the proposed project.  
  
Rachel Forbes, MD, MBA is a kidney transplant surgeon at Vanderbilt University Medical Center with clinical 
and research interests in expanding access to transplantation through organ utilization and optimization. She 
has experience with clinical and translational research including evaluating the effect of pulsatile pump 
perfusion on Hepatitis C Virus Transmission and in collaboration with Dr. William Fissell works on efforts to 
create a bioartificial kidney.  
  
Ciara Shaver, MD, PhD is a physician scientist and transplant pulmonologist. She has a basic and translational 
research laboratory focused on mechanisms of donor organ injury and post-transplant outcomes. She has 
extensive experience in translational studies of biomarkers and organ injuries during critical illness. She is 
codirector of the Laboratory for Science and Translational in Critical Illness and is funded by an R01. For this 
project, she will assist Dr. Crannell with sample processing and biomarker assessment and will provide 
guidance on statistical analysis.  
Peter Reese, MD, Ph.D. Dr. Reese is the founding director of the Vanderbilt Center for Transplant Science. He 
is a board-certified nephrologist with subspecialty training in transplantation. Dr. Reese has a strong track 
record in conducting epidemiological studies and clinical trials to improve clinical outcomes of kidney transplant 
recipients. Dr. Reese will provide input on renal assessment at the cellular and organ levels. 
 
Matthew Bacchetta, MD is Professor of Surgery and Biomedical Engineering, the Surgical Director of the  
Vanderbilt Lung Institute, and Director of the Laboratory for Organ Regeneration, Recovery, and Replacement 
(LOR3) at VUMC. He is the co-inventor of human-xenogeneic cross circulation for organ recovery and has 
been advancing development of this technology for more than a decade. Dr. Bacchetta has extensive 
experience with storing human lungs at 10°C for transplant. He has collaborative relationships with the entire 
project team. He has had continuous research funding from NIH, Department of Defense, foundations, and 
industry partners for more than 20 years and has expertise translating novel products to commercial use.  
  
  
  
  
  
  
  
 
 

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References:   
1. 
OPTN National Transplant Data. Accessed April 10, 2024. https://optn.transplant.hrsa.gov/data/view-
datareports/national-data/#  
2. 
Lentine KL, Smith JM, Miller JM, et al. OPTN/SRTR 2021 Annual Data Report: Kidney Organ Procurement and 
Transplantation Network, United Network for Organ Sharing.  
3. 
Swanson KJ, Bhattarai M, Parajuli S. Delayed graft function: current status and future directions. Curr Opin Organ 
Transplant. 2023;28(1):1-7. doi:10.1097/MOT.0000000000001034  
4. 
Harhay M, Lin E, Pai A, et al. Early rehospitalization after kidney transplantation: assessing preventability and 
prognosis. Am J Transplant. 2013;13(12):3164-3172. doi:10.1111/ajt.12513  
5. 
Butala NM, Reese PP, Doshi MD, Parikh CR. Is delayed graft function causally associated with long-term outcomes 
after kidney transplantation? Instrumental variable analysis. Transplantation. 2013;95(8):1008-1014. 
doi:10.1097/TP.0b013e3182855544  
6. 
Hall IE, Reese PP, Doshi MD, et al. Delayed Graft Function Phenotypes and 12-Month Kidney Transplant Outcomes. 
Transplantation. 2017;101(8):1913-1923. doi:10.1097/TP.0000000000001409  
7. 
Chouchani ET, Pell VR, Gaude E, et al. Ischaemic accumulation of succinate controls reperfusion injury through 
mitochondrial ROS. Nature. 2014;515(7527):431-435. doi:10.1038/nature13909  
8. 
Hendriks KDW, Brüggenwirth IMA, Maassen H, et al. Renal temperature reduction progressively favors 
mitochondrial ROS production over respiration in hypothermic kidney preservation. J Transl Med. 2019;17(1). 
doi:10.1186/s12967-019-2013-1  
9. 
Ali A, Wang A, Ribeiro RVP, et al. Static Lung Storage at 10°C Maintains Mitochondrial Health and Preserves Donor 
Organ Function. Vol 13.; 2021. https://www.science.org  
10. 
Cordes T, Lucas A, Divakaruni AS, Murphy AN, Cabrales P, Metallo CM. Itaconate modulates tricarboxylic acid and 
redox metabolism to mitigate reperfusion injury. Mol Metab. 2020;32:122-135. doi:10.1016/j.molmet.2019.11.019  
11. 
Ali A, Hoetzenecker K, Luis Campo-Cañaveral de la Cruz J, et al. Extension of Cold Static Donor Lung Preservation at 
10°C. NEJM Evidence. 2023;2(6). doi:10.1056/evidoa2300008  
12. 
Tracy KM, Shishido Y, Harris TR, et al. Static Storage at 10°C Improves Liver Allograft Function in a Porcine DCD 
Model.  
13. 
Petrovic M, Kuo M, Dubray J, Forbes R, Miller A, Reese P, Shaver C, Bacchetta M, Crannell WC. A Deceased Donor 
Kidney Transplant After 10°C Static Storage. Clin Transplant. 2025 Oct;39(10):e70331. doi: 10.1111/ctr.70331. 
PMID: 41004187. 
14. 
Hall IE, Yarlagadda SG, Coca SG, et al. IL-18 and urinary NGAL predict dialysis and graft recovery after kidney 
transplantation. Journal of the American Society of Nephrology. 2010;21(1):189-197. 
doi:10.1681/ASN.2009030264  
15. 
Parikh CR, Jani A, Mishra J, et al. Urine NGAL and IL-18 are predictive biomarkers for delayed graft function 
following kidney transplantation. American Journal of Transplantation. 2006;6(7):1639-1645. 
doi:10.1111/j.16006143.2006.01352.x  
16. 
Nasralla D, Coussios CC, Mergental H, et al. A randomized trial of normothermic preservation in liver 
transplantation. Nature. 2018;557(7703):50-56. doi:10.1038/s41586-018-0047-9  
17. 
Shudo Y, Leacche M, Copeland H, et al. A Paradigm Shift in Heart Preservation: Improved Post-transplant Outcomes 
in Recipients of Donor Hearts Preserved With the SherpaPak System. ASAIO Journal. 2023;69(11):9931000. 
doi:10.1097/MAT.0000000000002036  
18. 
Moayedifar R, Shudo Y, Kawabori M, et al. Recipient Outcomes with Extended Criteria Donors Using Advanced 
Heart Preservation: An Analysis of the GUARDIAN Heart Registry. The Journal of Heart and Lung Transplantation. 
Published online December 2023. doi:10.1016/j.healun.2023.12.013