CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
SherpaPak™ Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05194514
NCT05194514N/ACompleted

Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study

Cedars-Sinai Medical Center·interventional·Posted Jan 18, 2022·Updated Feb 21, 2025

In Brief

A clinical study evaluating SherpaPak™ Device and Cold Storage for Organ Transplant. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJan 18, 2022
Enrollment StartMay 11, 2022
Primary CompletionAug 31, 2023
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.5 years ago

Interventions

SherpaPak™ Devicedevice

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.

Cold Storageother

FDA-approved method for organ procurement