Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04284319 |
| Other study ID # |
19-01664 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2020 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
NYU Langone Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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the donor is withdrawn from life support (i.e., discontinuation of mechanical ventilation and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.
