N/A
N=20
Trial to Compare the SherpaPak™ Device vs Cold Storage
Organ Transplant
Bottom Line
View on ClinicalTrials.gov: NCT05194514 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Feb 2025
Primary outcome: Primary: Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SherpaPak™ Device (Device); Cold Storage (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cedars-Sinai Medical Center
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) |
10; 10 | — |
| PRIMARY 30-day Post-transplant Survival |
10; 9 | — |
| PRIMARY Freedom From 30-day Ischemic Reperfusion Injury |
10; 8 | — |
| PRIMARY Freedom From 30-day Biopsy Proven Rejection |
9; 8 | — |
| PRIMARY Freedom From 30-day Any-treated Rejection |
9; 8 | — |
| SECONDARY Cardiac Index |
3.1; 3.5 | — |
| SECONDARY Cardiac Output |
5.6; 6.5 | — |
| SECONDARY Mean Arterial Pressure |
79; 83 | — |
| SECONDARY Pulmonary Arterial Pressure |
25; 22 | — |
| SECONDARY Vasoactive-Inotropic Score |
264.1; 395.3 | — |
| SECONDARY Hospital Length of Stay |
15.1; 21.1 | — |
| SECONDARY Acute Cellular Rejection |
5; 3 | — |
| SECONDARY 1R |
5; 3 | — |
| SECONDARY Antibody Mediated Rejection |
1; 1 | — |
| SECONDARY pAMR 1 |
1; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05194514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.