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NCT Number: NCT05038943

Evaluation of Safety and Effectiveness of The SherpaPak 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.

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Key information

Conditions

Heart Transplant Failure Death Determination of Death Extracorporeal Membrane Oxygenation Outcomes Research Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Paragonix SherpaPak Cardiac Transport System

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2021
Registry last updated
Sep 28, 2023

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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