Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04626284
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2020-11-02
Brief Title:
Safety and Effectiveness of NRP for DCD Heart Transplantation
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Clinical Trial to Evaluate the Safety and Effectiveness of Normothermic Regional Perfusion NRP for Resuscitation of Hearts From Donation After Circulatory Death DCD
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DCDNRPHeart
Brief Summary:
This is a prospective observational pilot trial to evaluate the feasibility of heart transplantation using normothermic regional perfusion NRP donation after donor circulatory death DCD Normothermic regional perfusion 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 DCD transplantation of a heart has been hampered due to concern about the graft viability after the obligatory period of warm ischemia and also the limited ability to assess the graft function after the cessation of circulation Normothermic regional perfusion restores the circulation and enables in-situ reanimation of thoracic and abdominal organs after the circulatory determination of death For heart transplantation 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 packyears and normal baseline cardiac function EF50 assessed with transthoracic echocardiogram After the authorization for research has been obtained from DCD surrogate the organs will be allocated through UNOS When all parties are present and ready the donor will be withdrawn from life support ie discontinuation of mechanical ventilation and any vasoactive medications After circulatory arrest occurs death is declared by a physician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 Nebraska 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 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 UNMC 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 LiveOnNE 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
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 UNMC 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 LiveOnNE 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None