Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death

February 10, 2023 updated by: NYU Langone Health

Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD): A Pilot Study

Normothermic regional perfusion (NRP) utilizes Extracorporeal Membrane Oxygenation (ECMO) or cardiopulmonary bypass to reperfuse the heart and other organs in situ after isolation and ligation of the cerebral vessels. In situ resuscitation of the heart has the added advantage of allowing full hemodynamic and echocardiographic assessment of the donor heart prior to final acceptance for transplantation without the imminent danger of ongoing warm ischemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current procedure of DCD organ donation and procurement follows a well-established course for lung, liver, kidney and pancreas transplantation in the United States. After consent has been obtained, the organs are allocated through UNOS. When all parties are present and ready, the donor is withdrawn from life support (i.e., discontinuation of mechanical ventilation and any vasoactive medications). The surgical teams are generally present on the premises but not at the donor's bedside. After circulatory arrest occurs, which is determined by the absence of pulse and organized rhythmic cardiac activity, death is declared by a physician not associated with the transplant teams. Subsequently a period of stand-off is observed (5 minutes for organs donated in New York) to ensure complete cessation of the circulation before organ procurement is commenced. If after withdrawal of life support the patient does not progress to circulatory death within the allotted time (variable among hospitals, but 180 minutes in this study), the procurement is abandoned and the patient is transferred out of the operating room and placed on palliative measures.

Given that DCD organ donation is already currently practiced in the US, the same standard approach defined by each state and locality can also be applied to DCD heart donation and will be followed for this protocol at NYULH. However, this protocol will utilize a normothermic regional perfusion (NRP) strategy that involves reestablishment of circulatory blood flow after the period of circulatory arrest has been established and the 5 minutes of standoff time has passed. The local Organ Procurement Organization (LiveOnNY) and NYULH Medical Leadership have reviewed and approved this approach to DCD heart donation. Specifically, normothermic regional perfusion involves the following steps:

  1. Opening the chest through a standard sternotomy used for heart and lung procurement.
  2. Ligation of the all the blood vessels that supply blood to the brain to ensure that blood flow to the brain is not reestablished once circulation is restarted as described below.
  3. Standard cannulation of the aorta and the right atrium as is done for cardiac surgical procedures.
  4. Initiation of cardiopulmonary bypass, which will re-establish the flow of blood to all organs of the body including the heart under normothermia. The initial step for ligation of the blood vessels to the head is necessary to ensure that blood flow to the brain does not occur.

Once blood flow to the heart is established, the heart will start beating. At 30 minute intervals, the donor will be separated from cardiopulmonary bypass and the heart will be assessed for functionality. If accepted standard DBD procurement will commence. The heart transplantation surgery on the potential recipient will only begin once the heart has been accepted as suitable.

If after assessment the heart is not suitable, cardiopulmonary bypass will be restarted. The donor heart will be reassessed at 30 minute intervals up to 180 minutes. If no significant acceptable recovery occurs and the heart is not deemed suitable for transplantation, then the study will be terminated, but the remaining organs can be recovered as standard practice.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Recipient is ≥ 18 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 at NYU Langone Health Transplant Institute

Exclusion Criteria:

  1. Recipient is < 18 years old
  2. Recipient, or their designated healthcare proxy, is unable to sign informed consent
  3. Recipient is participating in another interventional trial
  4. Recipient has a known history of HIV infection
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DCD Heart Transplantation Using NRP
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Procedure: DCD Heart Transplantation Using NRP
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful NRP-DCD Heart transplants
Time Frame: One Year
The primary outcome is the rate of successful NRP-DCD heart transplants.
One Year

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of living authorized representatives who authorize candidate's organs for donation and research
Time Frame: One Year
One Year
Number of candidates who are transferred to NYU Langone Health for donation after circulatory death (DCD)
Time Frame: One Year
One Year
Number of candidates who progress to death after withdrawal of care
Time Frame: One Year
One Year
Number of Donors whose hearts are deemed suitable for donation following normothermic regional perfusion (NRP)
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

November 30, 2022

Study Completion (ACTUAL)

November 30, 2022

Study Registration Dates

First Submitted

January 24, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (ACTUAL)

February 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-01664

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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