Organ TransplantSherpaPakNCT05194514

Trial to Compare the SherpaPak™ Device vs Cold Storage

A study testing SherpaPak™ Device and Cold Storage in people with Organ Transplant, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Organ Transplant
What is being tested?: SherpaPak™ Device and Cold Storage
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 11 May 2022to 31 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

Re-do heart transplant
Multi-organ transplant

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Organ Transplant
Being tested: SherpaPak™ Device, Cold Storage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SherpaPak™ DeviceDevice
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 StorageOther
FDA-approved method for organ procurement

Study groups in NCT05194514
Study group	Role	What they receive
SherpaPak™ Cardiac Transport System	Other	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. Receives: Device: SherpaPak™ Device
Cold Storage	Other	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. Receives: Other: Cold Storage

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 24 hours post-transplant
30-day Post-transplant Survival
Measured: 30 day post heart transplant (htx)
Freedom From 30-day Ischemic Reperfusion Injury
Measured: 30 day post htx
Freedom From 30-day Biopsy Proven Rejection
Measured: 30 day post htx
Freedom From 30-day Any-treated Rejection
Measured: 30 day post htx

Secondary outcomes (10)

Cardiac Index
Measured: 24 hours post-transplant
Cardiac Output
Measured: 24 hours post-transplant
Mean Arterial Pressure
Measured: 24 hours post-transplant
Pulmonary Arterial Pressure
Measured: 24 hours post-transplant
Vasoactive-Inotropic Score
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)
Measured: 24 hours post-transplant
Hospital Length of Stay
Hospital Length of Stay
Measured: within 30 days
Acute Cellular Rejection
Measured: 30 days
1R
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
Measured: 30 days
Antibody Mediated Rejection
Measured: 30 days
pAMR 1
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.
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 May 202231 Aug 2024

First posted18 Jan 2022
Study start11 May 2022
Primary completion31 Aug 2023
Study completion31 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Organ TransplantStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05194514
Sponsor's protocol ID: STUDY00001753
Acronym: SherpaPak
Status last verified: Feb 2025
First submitted: 23 Dec 2021
Last updated: 21 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Data that underlies the results reported in this article, after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Organ Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Trial to Compare the SherpaPak™ Device vs Cold Storage of Donor Hearts in Transplantation: A Pilot Study
ClinicalTrials.gov ID: NCT05194514
Acronym / sponsor ID: SherpaPak / STUDY00001753
Conditions: Organ Transplant
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Study start: 11 May 2022 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 18 Jan 2022 (actual)
Results: Posted 21 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Investigator's are doing this study to see which method of organ preservation leads to better outcomes for donated 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SherpaPak™ Cardiac Transport System	Other	Device: SherpaPak™ DeviceWhen 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	Other	Other: Cold StorageWhen 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)

Key exclusion criteria (2 listed)

Re-do heart transplant
Multi-organ transplant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SherpaPak™ DeviceThe 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.	Device	SherpaPak™ Cardiac Transport System
Cold StorageFDA-approved method for organ procurement	Other	Cold Storage

Primary outcome

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)
30-day Post-transplant Survival
Time frame: 30 day post heart transplant (htx)
Freedom From 30-day Ischemic Reperfusion Injury
Time frame: 30 day post htx
Freedom From 30-day Biopsy Proven Rejection
Time frame: 30 day post htx
Freedom From 30-day Any-treated Rejection
Time frame: 30 day post htx

10 secondary outcomes

Cardiac Index
Time frame: 24 hours post-transplant
Cardiac Output
Time frame: 24 hours post-transplant
Mean Arterial Pressure
Time frame: 24 hours post-transplant
Pulmonary Arterial Pressure
Time frame: 24 hours post-transplant
Vasoactive-Inotropic Score
Time frame: 24 hours post-transplant
Hospital Length of Stay
Time frame: within 30 days
Acute Cellular Rejection
Time frame: 30 days
1R
Time frame: 30 days
Antibody Mediated Rejection
Time frame: 30 days
pAMR 1
Time frame: 30 days

Results and safety

Results posted to the registry on 21 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cold Storage	10	10
SherpaPak	10	10

Primary outcome: Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle)

Time frame: 24 hours post-transplant. Count of participants. Unit: Participants

Measure	Standard Care Cold Storage n = 10	Sherpapak Cardiac Transport n = 10
Value	10	10

Primary outcome: 30-day Post-transplant Survival

Time frame: 30 day post heart transplant (htx). Count of participants. Unit: Participants

Measure	Standard Care Cold Storage n = 10	Sherpapak Cardiac Transport n = 10
Value	10	9

Primary outcome: Freedom From 30-day Ischemic Reperfusion Injury

Time frame: 30 day post htx. Count of participants. Unit: Participants

Measure	Standard Care Cold Storage n = 10	Sherpapak Cardiac Transport n = 10
Value	10	8

Primary outcome: Freedom From 30-day Biopsy Proven Rejection

Time frame: 30 day post htx. Count of participants. Unit: Participants

Measure	Standard Care Cold Storage n = 10	Sherpapak Cardiac Transport n = 10
Value	9	8

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Within 30 days post transplant. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Care Cold Storage	1 of 10 (10%)	0 of 10 (0%)	0 of 10
Sherpapak Cardiac Transport	2 of 10 (20%)	0 of 10 (0%)	1 of 10

Limitations and caveats (from the sponsor): There are several limitations to our study. First, the small sample size limits our ability to detect clinical differences between the groups. Second, our primary clinical end points were only followed out to 30-days warranting further randomized trials aimed at assessing the long-term effects on clinical outcomes. Third, cardiac samples have a high dynamic range of proteins due to the abundance of contractile machinery within cardiomyocytes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data that underlies the results reported in this article, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fardad Esmailian principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SherpaPak™ Device and Cold Storage in people with Organ Transplant, run by Cedars-Sinai Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of Moderate to Severe Primary Graft Dysfunction (Left or Right Ventricle) (time frame: 24 hours post-transplant). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.