Safety and Effectiveness of NRP for DCD Heart Transplantation
DCDNRPHeart
Clinical Trial to Evaluate the Safety and Effectiveness of Normothermic Regional Perfusion (NRP) for Resuscitation of Hearts From Donation After Circulatory Death (DCD)
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedStudy Start
First participant enrolled
January 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2022
CompletedSeptember 28, 2023
September 1, 2023
1.3 years
November 2, 2020
September 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Utilization rate
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
Date from the first DCD NRP Heart procurement until the 25th DCD NRP heart procurement, assessed up to 36 months
Secondary Outcomes (4)
Graft survival
From date of the transplantation to date of death or retransplantation, whichever comes first, assessed up to 12 months
Primary Graft Dysfunction (PGD)
From day of heart transplantation up to 72 hours post-transplantation
Acute cellular rejection (ACR)
From day of heart transplantation up to 1 year post-transplantation
Antibody mediated rejection (AMR)
From day of heart transplantation up to 1 year post-transplantation
Study Arms (1)
Donors After Circulatory Determined death
EXPERIMENTALRecipients receiving an organ from donors after circulatory determined death
Interventions
Eligibility Criteria
You may qualify if:
- Recipient is ≥ 19 years old
- Recipient, or their designated healthcare proxy, is able and willing to sign informed consent
- Recipient meets standard listing criteria for heart transplantation
You may not qualify if:
- Recipient is \< 19 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Related Publications (4)
Barnard CN. The operation. A human cardiac transplant: an interim report of a successful operation performed at Groote Schuur Hospital, Cape Town. S Afr Med J. 1967 Dec 30;41(48):1271-4. No abstract available.
PMID: 4170370RESULTDhital KK, Chew HC, Macdonald PS. Donation after circulatory death heart transplantation. Curr Opin Organ Transplant. 2017 Jun;22(3):189-197. doi: 10.1097/MOT.0000000000000419.
PMID: 28379853RESULTMesser S, Page A, Colah S, Axell R, Parizkova B, Tsui S, Large S. Human heart transplantation from donation after circulatory-determined death donors using normothermic regional perfusion and cold storage. J Heart Lung Transplant. 2018 Jul;37(7):865-869. doi: 10.1016/j.healun.2018.03.017. Epub 2018 Mar 30.
PMID: 29731238RESULTChew HC, Iyer A, Connellan M, Scheuer S, Villanueva J, Gao L, Hicks M, Harkness M, Soto C, Dinale A, Nair P, Watson A, Granger E, Jansz P, Muthiah K, Jabbour A, Kotlyar E, Keogh A, Hayward C, Graham R, Spratt P, Macdonald P, Dhital K. Outcomes of Donation After Circulatory Death Heart Transplantation in Australia. J Am Coll Cardiol. 2019 Apr 2;73(12):1447-1459. doi: 10.1016/j.jacc.2018.12.067.
PMID: 30922476RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marian Urban, MD, PhD
Assistant Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 12, 2020
Study Start
January 3, 2021
Primary Completion
April 8, 2022
Study Completion
April 8, 2022
Last Updated
September 28, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share