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NCT04626284: DCDNRPHeart

Safety and Effectiveness of NRP for DCD Heart Transplantation

Completed NA Last updated 28 September 2023
What this trial tests

NA trial testing Heart Transplantation in Heart Transplant Failure in 10 participants. Completed in 8 April 2022.

Timeline
3 January 2021
Primary endpoint
8 April 2022
8 April 2022

Quick facts

Lead sponsorUniversity of Nebraska
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment10
Start date3 January 2021
Primary completion8 April 2022
Estimated completion8 April 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Nebraska

Who can join

19 and older, any sex, with Heart Transplant Failure or Determination of Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cardiac function unchanged following reanimation with normothermic regional perfusion in donation after circulatory death.
    Markin NW, Chacon MM, Castleberry AW, Fristoe L, et al · · 2022 · cited 3× · PMID 36276687 · DOI 10.1016/j.xjtc.2022.07.018

Verify or expand the search:

Other recruiting trials for Heart Transplant Failure

Currently open trials in the same condition.

Other University of Nebraska trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04626284.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing