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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04626284
Other study ID # 0460-20-FB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 3, 2021
Est. completion date April 8, 2022

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Procedure:
Heart Transplantation
Heart Transplantation

Locations

Country Name City State
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Chew 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 — View Citation

Dhital 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. — View Citation

Messer 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Graft survival Survival of the graft censored either at the time of death of the recipient or retranaplantation From date of the transplantation to date of death or retransplantation, whichever comes first, assessed up to 12 months
Secondary Primary Graft Dysfunction (PGD) Primary Graft Dysfunction as defined by ISHLT From day of heart transplantation up to 72 hours post-transplantation
Secondary Acute cellular rejection (ACR) Biopsy proven acute cellular rejection requiring treatment From day of heart transplantation up to 1 year post-transplantation
Secondary Antibody mediated rejection (AMR) Biopsy proven antibody mediated rejection From day of heart transplantation up to 1 year post-transplantation
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