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

Not Applicable

Completed

• Conditions: Outcomes Research; Extracorporeal Membrane Oxygenation; Heart Transplant Failure; Determination of Death
• Interventions: Device: Paragonix SherpaPak Cardiac Transport System

• Registration Number: NCT05038943
• Lead Sponsor: University of Nebraska

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.

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 Timeline

• Study First Submitted: 2021-08-31
• Study First Submitted QC: 2021-09-08
• Study First Posted: 2021-09-09
• Study Start: 2021-09-15
• Primary Completion: 2022-04-08
• Study Completion: 2022-04-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SherpaPak	Paragonix SherpaPak Cardiac Transport System	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

Primary Outcome Measures

Name	Time	Method
Primary Graft Dysfunction (PGD)	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

Name	Time	Method
Intensive Care Unit & Hospital length of stay in days	1 year	Intensive Care Unit \& Hospital length of stay in days
Duration of vasoactive-inotropic support in days	1 year	Duration of vasoactive-inotropic support in days
Survival at discharge	1 year	Survival at discharge 30-day, 90-day, 1-year
Need for cardioversion or pacing to restart transplanted heart	72 hours	Need for cardioversion or pacing to restart transplanted heart
Vasoactive-inotropic score (VIS)	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).

Trial Locations

Locations (1)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States