Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- 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
- 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).
- Duration of vasoactive-inotropic support in days [1 year]
Duration of vasoactive-inotropic support in days
- Intensive Care Unit & Hospital length of stay in days [1 year]
Intensive Care Unit & Hospital length of stay in days
- Survival at discharge [1 year]
Survival at discharge 30-day, 90-day, 1-year
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Recipient is ≥ 19 years old
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Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
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Recipient meets standard listing criteria for heart transplantation
Exclusion Criteria:
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Recipient is < 19 years old
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Recipient, or their designated healthcare proxy, is unable to sign informed consent
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
Sponsors and Collaborators
- University of Nebraska
Investigators
- Principal Investigator: Marian Urban, MD, PhD, Assistant Professor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0478-21-FB