Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05038943
Study type Interventional
Source University of Nebraska
Contact
Status Completed
Phase N/A
Start date September 15, 2021
Completion date April 8, 2022

See also
  Status Clinical Trial Phase
Completed NCT03685383 - Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation N/A
Not yet recruiting NCT05106491 - Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients N/A
Recruiting NCT05699005 - Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO Phase 1
Recruiting NCT05444764 - PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Not yet recruiting NCT05341687 - Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Recruiting NCT03766282 - Pharmacokinetics in Extracorporeal Membrane Oxygenation
Completed NCT03355625 - Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
Completed NCT01521195 - Oxygen Consumption In Critically Ill Children N/A
Recruiting NCT04620070 - ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest N/A
Recruiting NCT06062212 - Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Recruiting NCT05730114 - Monitoring Antiplatelet Drugs in Cardiac Arrest Patients
Completed NCT05154071 - Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality
Recruiting NCT04536272 - Reduced Anticoagulation Targets in ECLS (RATE) Phase 3
Completed NCT05693051 - Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Completed NCT03764319 - Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO N/A
Recruiting NCT05762029 - Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
Completed NCT02995811 - Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness
Recruiting NCT04754854 - Reduction of Blood Recirculation in Veno-Venous ECMO
Recruiting NCT05527717 - Revascularization Strategy of Multivessel Disease for Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock Undergoing Veno-arterial Extracorporeal Membrane Oxygenator Phase 4