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Heart Transplant FailureNCT05038943

Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation

A study testing Paragonix SherpaPak Cardiac Transport System in people with Heart Transplant Failure and Determination of Death, run by University of Nebraska 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

This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (TA-NRP). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Paragonix SherpaPak Cardiac Transport System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
15 Sep 2021to 8 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recipient is ≥ 19 years old
  • Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
  • Recipient meets standard listing criteria for heart transplantation

Who cannot join

  • Recipient is < 19 years old
  • Recipient, or their designated healthcare proxy, is unable to sign informed consent
  • Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Evaluation of Safety and Effectiveness of The Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation

This is a prospective, pilot trial to evaluate the safety and effectiveness of The Paragonix SherpaPak™ Cardiac Transport System ("SherpaPak CTS") in transportation of cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion (TA-NRP). SherpaPak™ CTS is an ultraportable hypothermic preservation and transport system that has been approved by United States Food \& Drug Administration (FDA) for clinical use in heart transplantation.

Read the detailed description

The investigators will accept donors between the ages of 18 and 49 without any known history of coronary artery disease, insulin dependent diabetes, or long-term smoking (>20 pack/years) and normal baseline cardiac function (EF>50) assessed with transthoracic echocardiogram. Donors will be selected and matched to the recipients based on standard criteria (blood group, cross-match, size match, and clinical stability). The current procedure of donation after circulatory death (DCD) and procurement follows a well-established course. After consent is obtained, the organs are allocated through United Network for Organ Sharing (UNOS). All organs will be recovered with protocolized UNMC DCD TA-NRP technique that involves reestablishment of blood flow in-situ after donor's circulatory arrest using portable venoarterial extracorporeal membrane oxygenation (VA-ECMO). Organs will be transported from a donor site to recipient center with the SherpaPak™ CTS. All organs will be transplanted at Nebraska Medicine. Recipients ("subjects") will be followed from transplant through one-year post-transplantation.

Being tested
Paragonix SherpaPak Cardiac Transport System
Keywords
Transplantation, heart, Normothermic Regional Perfusion, Organ transport
Medical subject headings
Death

What participants receive

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

  • Paragonix SherpaPak Cardiac Transport SystemDevice

    Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury

Study groups in NCT05038943
Study groupRoleWhat they receive
SherpaPakExperimentalcardiac allografts recovered from donors after circulatory determined death using thoracoabdominal normothermic regional perfusion will be transported to the recipient center in Paragonix SherpaPak Cardiac Transport System
Receives: Device: Paragonix SherpaPak Cardiac Transport System

What is being measured

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

  1. Primary Graft Dysfunction (PGD)

    PGD will be classified according to International Society for Heart and Lung Transplantation (ISHLT) classification into: PGD-LV Grade 1 (LVEF ≤ 40% by echocardiography, or Hemodynamics with RAP > 15 mm Hg, PCWP > 20 mm Hg, CI < 2.0 L/min/m2 (lasting more than 1 hour) requiring low-dose inotropes); PGD-LV Grade 2 (I. One criteria from the following: Left ventricular ejection fraction ≤ 40%, or Hemodynamic compromise with RAP > 15 mm Hg, PCWP > 20 mm Hg, CI < 2.0 L/min/m2, hypotension with MAP < 70 mm Hg (lasting more than 1 hour) II. One criteria from the following: High-dose inotropes-Inotrope score >10, or Newly placed IABP (regardless of inotropes)); PGD-LV Grade 3 ( Dependence on left or biventricular mechanical support including ECMO, LVAD, BiVAD, or percutaneous LVAD. Excludes requirement for IABP; PGD-RV (I. Hemodynamics with RAP > 15 mm Hg, PCWP < 15 mm Hg, CI < 2.0 L/min/m2, II. TPG < 15 mm Hg and/or pulmonary artery systolic pressure < 50 mm Hg, III. Need for RVAD)

    Measured: 72 hours

Secondary outcomes (5)

  1. Need for cardioversion or pacing to restart transplanted heart

    Need for cardioversion or pacing to restart transplanted heart

    Measured: 72 hours

  2. Vasoactive-inotropic score (VIS)

    The vasoactive-inotropic score (VIS) will be calculated as a weighted sum of all administered inotropes and vasoconstrictors, reflecting pharmacological support of the cardio-vascular system. Formula for VIS calculation: dopamine dose (µg/kg/min) + dobutamine dose (µg/kg/min) + 100 x epinephrine dose (µg/kg/min) + 100 x norepinephrine dose (µg/kg/min).

    Measured: 24, 48, and 72 hours

  3. Duration of vasoactive-inotropic support in days

    Duration of vasoactive-inotropic support in days

    Measured: 1 year

  4. Intensive Care Unit & Hospital length of stay in days

    Intensive Care Unit \& Hospital length of stay in days

    Measured: 1 year

  5. Survival at discharge

    Survival at discharge 30-day, 90-day, 1-year

    Measured: 1 year

Timeline

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

  1. First posted9 Sep 2021
  2. Study start15 Sep 2021
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Cardiac allografts recovered from donors after circulatory death with thoracoabdominal normothermic regional perfusion will be transported with Paragonix SherpaPak Cardiac Transport System to the recipient center
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038943
Sponsor's protocol ID
0478-21-FB
Status last verified
Sep 2023
First submitted
31 Aug 2021
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Radakovic D, Karimli S, Penov K, Schade I, Hamouda K, Bening C, Leyh RG, Aleksic I. First clinical experience with the novel cold storage SherpaPak system for donor heart transportation. J Thorac Dis. 2020 Dec;12(12):7227-7235. doi: 10.21037/jtd-20-1827.

    PubMed 33447411

  • Toldo S, Quader M, Salloum FN, Mezzaroma E, Abbate A. Targeting the Innate Immune Response to Improve Cardiac Graft Recovery after Heart Transplantation: Implications for the Donation after Cardiac Death. Int J Mol Sci. 2016 Jun 17;17(6):958. doi: 10.3390/ijms17060958.

    PubMed 27322252

  • Kobashigawa J, Zuckermann A, Macdonald P, Leprince P, Esmailian F, Luu M, Mancini D, Patel J, Razi R, Reichenspurner H, Russell S, Segovia J, Smedira N, Stehlik J, Wagner F; Consensus Conference participants. Report from a consensus conference on primary graft dysfunction after cardiac transplantation. J Heart Lung Transplant. 2014 Apr;33(4):327-40. doi: 10.1016/j.healun.2014.02.027. Epub 2014 Mar 5.

    PubMed 24661451

  • Yamazaki Y, Oba K, Matsui Y, Morimoto Y. Vasoactive-inotropic score as a predictor of morbidity and mortality in adults after cardiac surgery with cardiopulmonary bypass. J Anesth. 2018 Apr;32(2):167-173. doi: 10.1007/s00540-018-2447-2. Epub 2018 Jan 13.

    PubMed 29332153

Questions about this trial

What is this clinical trial studying?

A study testing Paragonix SherpaPak Cardiac Transport System in people with Heart Transplant Failure and Determination of Death, run by University of Nebraska 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 3 inclusion and 3 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 28 Sep 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary Graft Dysfunction (PGD) (time frame: 72 hours). 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 NCT05038943, which also lists 4 linked publications.

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 28 Sep 2023.

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