Determination of Death, Extracorporeal Membrane Oxygenation, Heart Transplant Failure, Outcomes Research
Conditions
Keywords
Transplantation, heart, Normothermic Regional Perfusion, Organ transport
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.
Interventions
DEVICEParagonix SherpaPak Cardiac Transport System
Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury
Sponsors
University of Nebraska
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed