Trial to Compare the SherpaPak™ Device vs Cold Storage

Not Applicable

Completed

Conditions: Organ Transplant

Interventions: Other: Cold Storage
Device: SherpaPak™ Device

Registration Number: NCT05194514

Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

Inclusion Criteria

Any sex/gender, 18 years of age or older listed for primary heart transplant.
Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies)

Exclusion Criteria

Re-do heart transplant
Multi-organ transplant

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold Storage	Cold Storage	When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System.
SherpaPak™ Cardiac Transport System	SherpaPak™ Device	When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System.

Primary Outcome Measures

Name	Time	Method
Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)	24 hours post-transplant	Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)
30-day Post-transplant Survival	30 day post heart transplant (htx)
Freedom From 30-day Ischemic Reperfusion Injury	30 day post htx
Freedom From 30-day Biopsy Proven Rejection	30 day post htx
Freedom From 30-day Any-treated Rejection	30 day post htx

Secondary Outcome Measures

Name	Time	Method
Cardiac Index	24 hours post-transplant
Cardiac Output	24 hours post-transplant
Mean Arterial Pressure	24 hours post-transplant
Pulmonary Arterial Pressure	24 hours post-transplant
Vasoactive-Inotropic Score	24 hours post-transplant	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)
Hospital Length of Stay	within 30 days	Hospital Length of Stay
Acute Cellular Rejection	30 days
1R	30 days	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
Antibody Mediated Rejection	30 days
pAMR 1	30 days	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.