Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Effectiveness of NRP for DCD Heart Transplantation (DCDNRPHeart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04626284
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Marian Urban, University of Nebraska

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.

Condition or disease Intervention/treatment Phase
Heart Transplant Failure Determination of Death Outcomes Research Death Procedure: Heart Transplantation Not Applicable

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 pack/years) and normal baseline cardiac function (EF>50) 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 (i.e., 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 3, 2021
Estimated Primary Completion Date : November 9, 2023
Estimated Study Completion Date : November 9, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donors After Circulatory Determined death
Recipients receiving an organ from donors after circulatory determined death
Procedure: Heart Transplantation
Heart Transplantation




Primary Outcome Measures :
  1. Utilization rate [ Time Frame: Date from the first DCD NRP Heart procurement until the 25th DCD NRP heart procurement, assessed up to 36 months ]
    Ratio of successful heart transplants using grafts obtained from DCD donors using NRO to the total number of DCD donors in whom NRP was used to procure an organ


Secondary Outcome Measures :
  1. Graft survival [ Time Frame: From date of the transplantation to date of death or retransplantation, whichever comes first, assessed up to 12 months ]
    Survival of the graft censored either at the time of death of the recipient or retranaplantation

  2. Primary Graft Dysfunction (PGD) [ Time Frame: From day of heart transplantation up to 72 hours post-transplantation ]
    Primary Graft Dysfunction as defined by ISHLT

  3. Acute cellular rejection (ACR) [ Time Frame: From day of heart transplantation up to 1 year post-transplantation ]
    Biopsy proven acute cellular rejection requiring treatment

  4. Antibody mediated rejection (AMR) [ Time Frame: From day of heart transplantation up to 1 year post-transplantation ]
    Biopsy proven antibody mediated rejection



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recipient is ≥ 19 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

Exclusion Criteria:

  1. Recipient is < 19 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626284


Contacts
Layout table for location contacts
Contact: Rachel E Gross, RN, BSN 402-559-3665 rachel.gross@unmc.edu
Contact: Barbara Hoover-Schultz, MS, MPA 4025590869 b.hooverschultz@unmc.edu

Locations
Layout table for location information
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Rachel E Gross, RN, BSN    402-559-3665    rachel.gross@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Investigators
Layout table for investigator information
Principal Investigator: Marian Urban, MD, PhD Assistant Professor
Publications of Results:
Layout table for additonal information
Responsible Party: Marian Urban, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT04626284    
Other Study ID Numbers: 460-20-FB
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marian Urban, University of Nebraska:
Heart transplantation
Donation after circulatory death
Normothermic regional perfusion
Additional relevant MeSH terms:
Layout table for MeSH terms
Death
Pathologic Processes