Death Clinical Trial
— DCDNRPHeartOfficial title:
Clinical Trial to Evaluate the Safety and Effectiveness of Normothermic Regional Perfusion (NRP) for Resuscitation of Hearts From Donation After Circulatory Death (DCD)
Verified date | September 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 8, 2022 |
Est. primary completion date | April 8, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Nebraska Medical Center | Omaha | Nebraska |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
United States,
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
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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