Safety and Effectiveness of NRP for DCD Heart Transplantation
NCT04626284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-09-28
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.
Conditions
- Heart Transplant Failure
- Determination of Death
- Outcomes Research
- Death
Interventions
- PROCEDURE
-
Heart Transplantation
Heart Transplantation
Sponsors & Collaborators
-
University of Nebraska
lead OTHER
Principal Investigators
-
Marian Urban, MD, PhD · Assistant Professor
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-03
- Primary Completion
- 2022-04-08
- Completion
- 2022-04-08
Countries
- United States
Study Locations
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