Trial to Compare the SherpaPak™ Device vs Cold Storage

Organ Transplant Clinical Trial

— SherpaPak  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05194514
• Other study ID #: STUDY00001753
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: March 2024

Study information

• Verified date: March 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Organ Transplant

Intervention

Device:
• SherpaPak™ Device
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.

Other:
• Cold Storage
FDA-approved method for organ procurement

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of moderate to severe primary graft dysfunction (left or right ventricle)	Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)	24 hours post-transplant
Secondary	Quantify Hemodynamic parameters	Percentage of Cardiac index, cardiac output, blood pressure, mean arterial pressure, pulmonary artery pressure, left atrial pressure, right atrial pressure, right ventricular pressure, stroke volume and ejection fraction	24 hours post-transplant
Secondary	Incidence of acute cellular rejection	Percentage of subjects without acute cellular rejection in the first 30 days after transplant	30 days post-transplant
Secondary	Incidence of antibody mediated rejection	Percentage of subjects with no antibody mediated rejection in the first 30 days after transplant.	30 days post-transplant