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

Extracorporeal Membrane Oxygenation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038943
• Other study ID #: 0478-21-FB
• Status: Completed
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: April 8, 2022

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 8, 2022
• Est. primary completion date: April 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Determination of Death
• Extracorporeal Membrane Oxygenation
• Heart Transplant Failure
• Outcomes Research

Intervention

Device:
• Paragonix SherpaPak Cardiac Transport System
Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	72 hours
Secondary	Need for cardioversion or pacing to restart transplanted heart	Need for cardioversion or pacing to restart transplanted heart	72 hours
Secondary	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).	24, 48, and 72 hours
Secondary	Duration of vasoactive-inotropic support in days	Duration of vasoactive-inotropic support in days	1 year
Secondary	Intensive Care Unit & Hospital length of stay in days	Intensive Care Unit & Hospital length of stay in days	1 year
Secondary	Survival at discharge	Survival at discharge 30-day, 90-day, 1-year	1 year