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SherpaPak™ Device vs Cold Storage for Solid Organ Transplant (SherpaPak Trial)

N/A

Waitlist Available

Led By Fardad Esmailian

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any sex/gender, 18 years of age or older listed for primary heart transplant.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post-transplant

Awards & highlights

SherpaPak Trial Summary

This trial is testing which method of organ preservation leads to better outcomes for donated hearts.

Who is the study for?

This trial is for adults over 18 awaiting their first heart transplant, who can legally consent and understand the study. They must accept a donor heart from specific regions like Northern California or farther. It's not for those needing multiple organ transplants or redoing a heart transplant.Check my eligibility

What is being tested?

The study compares two ways to keep donor hearts in good condition during transport: traditional cold storage on ice versus the SherpaPak™ system that maintains a constant temperature. Researchers want to know which method leads to better outcomes after transplantation.See study design

What are the potential side effects?

Since this trial focuses on organ preservation methods rather than medications, it doesn't directly involve drug side effects. However, there may be risks associated with how well each method preserves the heart and potential impact on transplant success.

SherpaPak Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and listed for a heart transplant.

SherpaPak Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post-transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post-transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absence of moderate to severe primary graft dysfunction (left or right ventricle)

Secondary outcome measures

Incidence of acute cellular rejection

Incidence of antibody mediated rejection

Quantify Hemodynamic parameters

SherpaPak Trial Design

2Treatment groups

Experimental Treatment

Group I: SherpaPak™ Cardiac Transport SystemExperimental Treatment1 Intervention

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.

Group II: Cold StorageExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,837 Total Patients Enrolled

1 Trials studying Solid Organ Transplant

30 Patients Enrolled for Solid Organ Transplant

Fardad EsmailianPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Cold Storage Clinical Trial Eligibility Overview. Trial Name: NCT05194514 — N/A

Solid Organ Transplant Research Study Groups: SherpaPak™ Cardiac Transport System, Cold Storage

Solid Organ Transplant Clinical Trial 2023: Cold Storage Highlights & Side Effects. Trial Name: NCT05194514 — N/A

Cold Storage 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194514 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are contributing to this clinical research?

"Confirmed, the clinicaltrials.gov database reveals that this trial is actively recruiting patients and began on 11th May 2022; with a last update of 23rd May 2022. The study requires 20 participants from 1 site to be enrolled."

Answered by AI

Are enrollments still open for this study?

"As indicated on clinicaltrials.gov, this medical experiment is still actively searching for participants. It was posted on May 11th 2022 and the listing has since been updated as recently as May 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Compare the SherpaPak™ Device vs Cold Storage

Fardad Esmailian 2022. "Trial to Compare the SherpaPak™ Device vs Cold Storage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05194514.