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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05038943
Recruitment Status : Completed
First Posted : September 9, 2021
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Marian Urban, University of Nebraska

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Heart Transplant Failure Determination of Death Outcomes Research Extracorporeal Membrane Oxygenation Device: Paragonix SherpaPak Cardiac Transport System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: Evaluation of Safety and Effectiveness of The Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation
Actual Study Start Date : September 15, 2021
Actual Primary Completion Date : April 8, 2022
Actual Study Completion Date : April 8, 2022

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SherpaPak
cardiac 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
 Device: Paragonix SherpaPak Cardiac Transport System
Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury


Outcome Measures
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Primary Outcome Measures :
  1. Primary Graft Dysfunction (PGD) [ Time Frame: 72 hours ]
    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)


Secondary Outcome Measures :
  1. Need for cardioversion or pacing to restart transplanted heart [ Time Frame: 72 hours ]
    Need for cardioversion or pacing to restart transplanted heart

  2. Vasoactive-inotropic score (VIS) [ Time Frame: 24, 48, and 72 hours ]
    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).

  3. Duration of vasoactive-inotropic support in days [ Time Frame: 1 year ]
    Duration of vasoactive-inotropic support in days

  4. Intensive Care Unit & Hospital length of stay in days [ Time Frame: 1 year ]
    Intensive Care Unit & Hospital length of stay in days

  5. Survival at discharge [ Time Frame: 1 year ]
    Survival at discharge 30-day, 90-day, 1-year


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Recipient is < 19 years old
  2. Recipient, or their designated healthcare proxy, is unable to sign informed consent
  3. 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038943


Locations
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United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
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Principal Investigator: Marian Urban, MD, PhD Assistant Professor
More Information
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Publications of Results:

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Responsible Party: Marian Urban, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT05038943    
Other Study ID Numbers: 0478-21-FB
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marian Urban, University of Nebraska:
Transplantation, heart
Normothermic Regional Perfusion
Organ transport
Additional relevant MeSH terms:
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Death
Pathologic Processes