Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-05-11
2024-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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.
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.
Cold Storage
FDA-approved method for organ procurement
Interventions
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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.
Cold Storage
FDA-approved method for organ procurement
Eligibility Criteria
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Inclusion Criteria
* 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
* Multi-organ transplant
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Fardad Esmailian
Professor of Surgery
Principal Investigators
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Fardad Esmailian
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY00001753
Identifier Type: -
Identifier Source: org_study_id
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