Intravenous Thyroxine for Heart-Eligible Organ Donors

Completed · Phase 3 · Has a placebo group

Conditions studied: Brain Death, Heart Failure

In brief

This randomized controlled trial will evaluate whether intravenous thyroxine infusion given to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more hearts transplanted than saline placebo

Key facts

Study ID

NCT04415658

Run by

Washington University School of Medicine

People needed

838

Starts

2020-12-01

Expected to finish

2022-12-06

Last updated by the study team

2024-01-10

Who can join

Age: 14 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Declared dead by neurologic criteria (brain dead)
• Authorization for organ donation and research
• On one or more vasopressors and/or inotropes

You may not qualify if…

• Brain death declared more than 24 hours prior
• Only vasopressor is vasopressin
• Weight < 45 kg (100 lbs)
• Known coronary artery disease or history of myocardial infarction
• Known valvular heart disease
• Prior sternotomy or cardiac surgery
• Donor at VA hospital
• Received intravenous or oral thyroxine within past month
• Known HIV+ status
• Other reason donor is unable to receive study drug (determined by on-site personnel)

Where it is running

• Donor Network of Arizona — Phoenix, Arizona, United States
• Lifesharing — San Diego, California, United States
• Donor Alliance — Denver, Colorado, United States
• OurLegacy — Maitland, Florida, United States
• Iowa Donor Network — North Liberty, Iowa, United States
• Midwest Transplant Network — Westwood, Kansas, United States
• Louisiana Organ Procurement Agency — Covington, Louisiana, United States
• Mid-America Transplant Services — St Louis, Missouri, United States
• Lifebanc — Cleveland, Ohio, United States
• LifeShare of Oklahoma — Oklahoma City, Oklahoma, United States
• Southwest Transplant Alliance — Dallas, Texas, United States
• Texas Organ Sharing Alliance — San Antonio, Texas, United States
• DonorConnect — Murray, Utah, United States
• LifeCenter Northwest — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.