Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DCD Heart Transplantation Using NRP
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Transplantation, Normothermic Regional Perfusion, NRP, Donation After Circulatory Death, DCD
Eligibility Criteria
Inclusion Criteria:
- Recipient is ≥ 18 years old
- Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
- Recipient meets standard listing criteria for heart transplantation at NYU Langone Health Transplant Institute
Exclusion Criteria:
- Recipient is < 18 years old
- Recipient, or their designated healthcare proxy, is unable to sign informed consent
- Recipient is participating in another interventional trial
- Recipient has a known history of HIV infection
- 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DCD Heart Transplantation Using NRP
Arm Description
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Outcomes
Primary Outcome Measures
Successful NRP-DCD Heart transplants
The primary outcome is the rate of successful NRP-DCD heart transplants.
Secondary Outcome Measures
Number of living authorized representatives who authorize candidate's organs for donation and research
Number of candidates who are transferred to NYU Langone Health for donation after circulatory death (DCD)
Number of candidates who progress to death after withdrawal of care
Number of Donors whose hearts are deemed suitable for donation following normothermic regional perfusion (NRP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04284319
Brief Title
Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death
Official Title
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD): A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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:
Opening the chest through a standard sternotomy used for heart and lung procurement.
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.
Standard cannulation of the aorta and the right atrium as is done for cardiac surgical procedures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Transplantation, Normothermic Regional Perfusion, NRP, Donation After Circulatory Death, DCD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DCD Heart Transplantation Using NRP
Arm Type
Experimental
Arm Description
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Intervention Type
Procedure
Intervention Name(s)
DCD Heart Transplantation Using NRP
Intervention Description
Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
Primary Outcome Measure Information:
Title
Successful NRP-DCD Heart transplants
Description
The primary outcome is the rate of successful NRP-DCD heart transplants.
Time Frame
One Year
Secondary Outcome Measure Information:
Title
Number of living authorized representatives who authorize candidate's organs for donation and research
Time Frame
One Year
Title
Number of candidates who are transferred to NYU Langone Health for donation after circulatory death (DCD)
Time Frame
One Year
Title
Number of candidates who progress to death after withdrawal of care
Time Frame
One Year
Title
Number of Donors whose hearts are deemed suitable for donation following normothermic regional perfusion (NRP)
Time Frame
One Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Recipient is ≥ 18 years old
Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
Recipient meets standard listing criteria for heart transplantation at NYU Langone Health Transplant Institute
Exclusion Criteria:
Recipient is < 18 years old
Recipient, or their designated healthcare proxy, is unable to sign informed consent
Recipient is participating in another interventional trial
Recipient has a known history of HIV infection
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Moazami, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heart Transplantation Using Normothermic Regional Perfusion Donation After Circulatory Death
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