Clinical trial NCT05194514: Trial to Compare the SherpaPak™ Device vs Cold Storage
Official title: Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Transplant
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)
timeFrame: 24 hours post-transplant
measure: 30-day Post-transplant Survival
timeFrame: 30 day post heart transplant (htx)
measure: Freedom From 30-day Ischemic Reperfusion Injury
timeFrame: 30 day post htx
measure: Freedom From 30-day Biopsy Proven Rejection
timeFrame: 30 day post htx
measure: Freedom From 30-day Any-treated Rejection
timeFrame: 30 day post htx
Secondary outcomes:
measure: Cardiac Index
timeFrame: 24 hours post-transplant
measure: Cardiac Output
timeFrame: 24 hours post-transplant
measure: Mean Arterial Pressure
timeFrame: 24 hours post-transplant
measure: Pulmonary Arterial Pressure
timeFrame: 24 hours post-transplant
measure: Vasoactive-Inotropic Score
timeFrame: 24 hours post-transplant
measure: Hospital Length of Stay
timeFrame: within 30 days
measure: Acute Cellular Rejection
timeFrame: 30 days
measure: 1R
timeFrame: 30 days
measure: Antibody Mediated Rejection
timeFrame: 30 days
measure: pAMR 1
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Fardad Esmailian
role: PRINCIPAL_INVESTIGATOR
References: