Clinical trial NCT05038943: Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
Official title: Evaluation of Safety and Effectiveness of The Paragonix™ SherpaPak Cardiac Transport System in Donation After Circulatory Death Heart Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Transplant Failure
Determination of Death
Outcomes Research
Extracorporeal Membrane Oxygenation
Keywords: Transplantation, heart
Normothermic Regional Perfusion
Organ transport
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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

Primary outcomes:
measure: Primary Graft Dysfunction (PGD)
timeFrame: 72 hours
Secondary outcomes:
measure: Need for cardioversion or pacing to restart transplanted heart
timeFrame: 72 hours
measure: Vasoactive-inotropic score (VIS)
timeFrame: 24, 48, and 72 hours
measure: Duration of vasoactive-inotropic support in days
timeFrame: 1 year
measure: Intensive Care Unit & Hospital length of stay in days
timeFrame: 1 year
measure: Survival at discharge
timeFrame: 1 year
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: Assistant Professor
name: Marian Urban, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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/ijms17060958.
citation: 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.
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.