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Completed

NCT Number: NCT05194514

Trial to Compare the SherpaPak™ Device vs Cold Storage

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.

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Key information

Conditions

Organ Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SherpaPak™ Device

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

Other

FDA-approved method for organ procurement

Primary outcomes

  1. Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)

    Time frame: 24 hours post-transplant

    Percentage of subjects without moderate to severe primary graft dysfunction (left or right ventricle)

  2. 30-day Post-transplant Survival

    Time frame: 30 day post heart transplant (htx)

  3. Freedom From 30-day Ischemic Reperfusion Injury

    Time frame: 30 day post htx

  4. Freedom From 30-day Biopsy Proven Rejection

    Time frame: 30 day post htx

  5. Freedom From 30-day Any-treated Rejection

    Time frame: 30 day post htx

Secondary outcomes

  1. Cardiac Index

    Time frame: 24 hours post-transplant

  2. Cardiac Output

    Time frame: 24 hours post-transplant

  3. Mean Arterial Pressure

    Time frame: 24 hours post-transplant

  4. Pulmonary Arterial Pressure

    Time frame: 24 hours post-transplant

  5. Vasoactive-Inotropic Score

    Time frame: 24 hours post-transplant

    Vasoactive inotropic scores (VIS) are used to measure the amount of cardiovascular support a patient is receiving at certain time point, for our study it was at 24hrs post transplant. Below is the calculation for the score.

    VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min).

    The minimum score is 0 if the patient does not require any support but there really isn't a maximum score as theoretically patients can be on any range of support. Higher values indicates that a patient is requiring a higher cardiovascular support at 24 hrs.

    VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min)

  6. Hospital Length of Stay

    Time frame: within 30 days

    Hospital Length of Stay

  7. Acute Cellular Rejection

    Time frame: 30 days

  8. 1R

    Time frame: 30 days

    1R is the rejection grade that referring to mild cellular rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild cellular mediated damage (interstitial/perivascular inflammation) using special stains. Only participants with acute cellular rejection were assessed for this Outcome Measure

  9. Antibody Mediated Rejection

    Time frame: 30 days

  10. pAMR 1

    Time frame: 30 days

    pAMR1 is the rejection grade that referring to mild antibody rejection based on pathological assessment that is standardized by ISHLT. Generally, pathologist look for signs of mild antibody-mediated damage using special stains to detect the presence of immune complexes.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: SherpaPak

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 18, 2022
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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