The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated hearts. There are two methods of organ preservation. The first method is the use of cold storage. With this method, the donor heart is stored in preservation fluid within bags that are then placed on ice and transported in a cooler. This is the usual method for transporting donor hearts. This is also known as "standard of care." The second method is the use of the SherpaPak™ Cardiac Transport System. With this method, the donor heart is kept at a steady, consistent temperature throughout transportation. This method is not typically used for transporting donor hearts. The study will include up to 20 people in total.
This is a randomized study and has 2 study groups. Participants will be randomly assigned to a group in a 1:1 ratio. * 50% chance of receiving a donor heart using the SherpaPak™ method, or * 50% chance of receiving a donor heart using the cold storage method. The research team will analyze data from the medical records from the heart transplant and clinic visits up to 30 days after the heart transplant. Participants will be in the study for about 30 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
The SherpaPak™ Cardiac Transport System has been developed to provide a safe, consistent method for cold ischemic storage of donor hearts for transplantation. This device is FDA approved.
FDA-approved method for organ procurement
Cedars Sinai Medical Center
Los Angeles, California, United States
Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)
Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)
Time frame: 24 hours post-transplant
30-day Post-transplant Survival
Time frame: 30 day post heart transplant (htx)
Freedom From 30-day Ischemic Reperfusion Injury
Time frame: 30 day post htx
Freedom From 30-day Biopsy Proven Rejection
Time frame: 30 day post htx
Freedom From 30-day Any-treated Rejection
Time frame: 30 day post htx
Cardiac Index
Time frame: 24 hours post-transplant
Cardiac Output
Time frame: 24 hours post-transplant
Mean Arterial Pressure
Time frame: 24 hours post-transplant
Pulmonary Arterial Pressure
Time frame: 24 hours post-transplant
Vasoactive-Inotropic Score
Vasoactive inotropic scores (VIS) are used to measure the amount of cardiovascular support a patient is receiving at certain time point, for our study it was at 24hrs post transplant. Below is the calculation for the score. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min). The minimum score is 0 if the patient does not require any support but there really isn't a maximum score as theoretically patients can be on any range of support. Higher values indicates that a patient is requiring a higher cardiovascular support at 24 hrs. VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min)
Time frame: 24 hours post-transplant
Hospital Length of Stay
Hospital Length of Stay
Time frame: within 30 days
Acute Cellular Rejection
Time frame: 30 days
1R
1R is the rejection grade that referring to mild cellular rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild cellular mediated damage (interstitial/perivascular inflammation) using special stains. Only participants with acute cellular rejection were assessed for this Outcome Measure
Time frame: 30 days
Antibody Mediated Rejection
Time frame: 30 days
pAMR 1
pAMR1 is the rejection grade that referring to mild antibody rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild antibody-mediated damage using special stains to detect the presence of immune complexes.
Time frame: 30 days
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