Trial to Compare the SherpaPak™ Device vs Cold Storage
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
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50% chance of receiving a donor heart using the SherpaPak™ method, or
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: SherpaPak™ Cardiac Transport System When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. |
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 When a matching donor heart from a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies) becomes available the recipient will be assigned a subject identification number and randomized 1:1 to receive a heart transported using either standard of care cold storage or the SherpaPak™ Cardiac Transport System. |
Other: Cold Storage
FDA-approved method for organ procurement
|
Outcome Measures
Primary Outcome Measures
- Absence of moderate to severe primary graft dysfunction (left or right ventricle) [24 hours post-transplant]
Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)
Secondary Outcome Measures
- Quantify Hemodynamic parameters [24 hours post-transplant]
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
- Incidence of acute cellular rejection [30 days post-transplant]
Percentage of subjects without acute cellular rejection in the first 30 days after transplant
- Incidence of antibody mediated rejection [30 days post-transplant]
Percentage of subjects with no antibody mediated rejection in the first 30 days after transplant.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Any sex/gender, 18 years of age or older listed for primary heart transplant.
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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.
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Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
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Subjects must receive and accept a non-local donor offer (from Northern California, Arizona, Nevada or farther geographies)
Exclusion Criteria:
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Re-do heart transplant
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Multi-organ transplant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cedars Sinai Medical Center | Los Angeles | California | United States | 90048 |
Sponsors and Collaborators
- Cedars-Sinai Medical Center
Investigators
- Principal Investigator: Fardad Esmailian, Cedars-Sinai Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00001753