Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

June 22, 2020

Primary Completion Date

June 23, 2024

Study Completion Date

July 31, 2024

Conditions
Lung Transplant
Interventions
DRUG

Regadenoson

If the donor lungs are randomized the experimental arm, the administration of Regadenoson will be performed at each study site by a qualified medical professional. The donor lungs will be perfused with Regadenoson at a dosage of 1.44 microgram/kg/min (based on donor's weight) for a minimum of three hours and maximum of four hours, using a pediatric syringe pump into the EVLP circuit (XVIVO Perfusion System). The infusion will begin within 10 minutes of the start of the EVLP procedure. Once the EVLP is complete the lungs are re-flushed with Perfadex solution (removing the Steen™ solution and Regadenoson; standard for EVLP).

DRUG

Placebo

If the donor lungs are randomized to the Steen solution arm, the donor lungs will be perfused with placebo at a rate equivalent to the dosage of Regadenoson (1.44 microgram/kg/min), for a minimum of three hours and maximum of four hours, using the same pediatric syringe pump. The infusion will begin within 10 minutes of the start of the EVLP procedure.

Trial Locations (2)

21201

University of Maryland Medical Center, Baltimore

"44195

Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

University of Maryland, Baltimore

OTHER

NCT04521569 - Regadenoson Infusion of Marginalized Donor Lungs in an EVLP System | Biotech Hunter | Biotech Hunter