Summary

Eligibility
for people ages 14-55 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors

Details

Background: Brain death frequently induces hemodynamic instability and cardiac stunning. Impairments in cardiac performance are major contributors to hearts from otherwise eligible organ donors not being transplanted. Deficiencies in pituitary hormones (including thyroid stimulating hormone) may contribute to hemodynamic instability and replacement of thyroid hormone has been proposed as a means of improving stability and increasing hearts available for transplantation. Intravenous thyroxine is commonly used in donor management. However, small controlled trials have not been able to demonstrate efficacy. Methods: This multicenter study will involve organ procurement organizations (OPOs) across the country. A total of 800 heart-eligible brain dead organ donors who require vasopressor support will be randomly assigned to intravenous thyroxine for at least 12-hours or saline placebo. The primary study hypothesis is that thyroxine treatment results in more hearts transplanted. Additional outcome measures are time to achieve hemodynamic stability (weaning off vasopressors) and improvement in cardiac ejection fraction on echocardiography. Discussion: This will be the largest randomized controlled study to evaluate the efficacy of thyroid hormone treatment for organ donor management. By collaborating across multiple OPOs, it will be able to enroll an adequate number of donors and be powered to definitively answer the critical question of whether treatment increases hearts transplanted and/or provides other hemodynamic benefits.

Keywords

Brain Death Heart Failure Organ donor Thyroxine Saline

Eligibility

You can join if…

Open to people ages 14-55

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

You CAN'T join 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)

Locations

  • Lifesharing accepting new patients
    San Diego California 92108 United States
  • Donor Network of Arizona accepting new patients
    Phoenix Arizona 85013 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Washington University School of Medicine
ID
NCT04415658
Phase
Phase 3
Study Type
Interventional
Last Updated