NCT05194514: SherpaPak

Trial to Compare the SherpaPak™ Device vs Cold Storage

Completed NA Results posted Last updated 21 February 2025

What this trial tests

NA trial testing SherpaPak™ Device in Organ Transplant in 20 participants. Completed in 31 August 2024.

Timeline

11 May 2022

Primary endpoint
31 August 2023

31 August 2024

Quick facts

Lead sponsor	Cedars-Sinai Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	20
Start date	11 May 2022
Primary completion	31 August 2023
Estimated completion	31 August 2024
Sites	1 location across United States

Drugs / interventions tested

• SherpaPak™ Device
• Cold Storage

Conditions studied

• Organ Transplant — all drugs for Organ Transplant →

Sponsor

Cedars-Sinai Medical Center

Who can join

18 and older, any sex, with Organ Transplant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) Primary · 24 hours post-transplant

Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)

Group	Value	95% CI
Standard Care Cold Storage	10
Sherpapak Cardiac Transport	10

30-day Post-transplant Survival Primary · 30 day post heart transplant (htx)

Group	Value	95% CI
Standard Care Cold Storage	10
Sherpapak Cardiac Transport	9

Freedom From 30-day Ischemic Reperfusion Injury Primary · 30 day post htx

Group	Value	95% CI
Standard Care Cold Storage	10
Sherpapak Cardiac Transport	8

Freedom From 30-day Biopsy Proven Rejection Primary · 30 day post htx

Group	Value	95% CI
Standard Care Cold Storage	9
Sherpapak Cardiac Transport	8

Freedom From 30-day Any-treated Rejection Primary · 30 day post htx

Group	Value	95% CI
Standard Care Cold Storage	9
Sherpapak Cardiac Transport	8

Cardiac Index Secondary · 24 hours post-transplant

Group	Value	95% CI
Standard Care Cold Storage	3.1	± 1.2
Sherpapak Cardiac Transport	3.5	± 1.1

Cardiac Output Secondary · 24 hours post-transplant

Group	Value	95% CI
Standard Care Cold Storage	5.6	± 1.3
Sherpapak Cardiac Transport	6.5	± 2.3

Mean Arterial Pressure Secondary · 24 hours post-transplant

Group	Value	95% CI
Standard Care Cold Storage	79	± 8
Sherpapak Cardiac Transport	83	± 14

Pulmonary Arterial Pressure Secondary · 24 hours post-transplant

Group	Value	95% CI
Standard Care Cold Storage	25	± 2
Sherpapak Cardiac Transport	22	± 6

Vasoactive-Inotropic Score Secondary · 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

Group	Value	95% CI
Standard Care Cold Storage	264.1	± 218
Sherpapak Cardiac Transport	395.3	± 418

Hospital Length of Stay Secondary · within 30 days

Hospital Length of Stay

Group	Value	95% CI
Standard Care Cold Storage	15.1	± 8
Sherpapak Cardiac Transport	21.1	± 14

Acute Cellular Rejection Secondary · 30 days

Group	Value	95% CI
Standard Care Cold Storage	5
Sherpapak Cardiac Transport	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 30 days post transplant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Care Cold Storage

Serious: 1/10 (10%)

Deaths: 0/10

Sherpapak Cardiac Transport

Serious: 2/10 (20%)

Deaths: 1/10

Serious adverse events (3 terms)

Reaction	System	Standard Care Cold Storage	Sherpapak Cardiac Transport
Epyema	Infections and infestations	—	—
Death	Cardiac disorders	—	—
Mediastinal Bleeding	Surgical and medical procedures	—	—

Most-reported serious reactions: Epyema, Death, Mediastinal Bleeding.

Data from ClinicalTrials.gov NCT05194514 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Outcomes of Machine Perfusion and Temperature Control Systems in Heart Transplantation: Where We Stand.
   Nasim U, Dorken-Gallastegi A, Dadson P, Hong Y. · · 2025 · cited 5× · PMID 40004682 · DOI 10.3390/jcm14041152