Safety and Effectiveness of NRP for DCD Heart Transplantation

NCT04626284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-28

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04626284 on ClinicalTrials.gov