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Published on: March 15, 2024
A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors
Rajat Dhar1, Dean Klinkenberg2, Gary Marklin2
1Department of Neurology, Washington University in St. Louis School of Medicine, St. Louis, MO, USA. dharr@wustl.edu.
Insights
Thyroid hormone (thyroxine) may improve stability in brain-dead organ donors, potentially increasing the number of viable hearts for transplantation. This large study will determine if thyroxine improves heart transplant rates and donor hemodynamics.
Area of Science:
- Cardiology
- Endocrinology
- Transplantation Medicine
Background:
- Brain death often causes hemodynamic instability and cardiac dysfunction, limiting heart transplantation.
- Pituitary hormone deficiencies, including thyroid-stimulating hormone, may worsen instability.
- Thyroid hormone replacement is explored to enhance donor stability and increase transplantable hearts.
Purpose of the Study:
- To evaluate the efficacy of intravenous thyroxine in improving hemodynamic stability in brain-dead organ donors.
- To determine if thyroxine treatment increases the proportion of hearts successfully transplanted.
- To assess the impact of thyroxine on cardiac function and donor hemodynamic parameters.
Main Methods:
- Multicenter randomized controlled trial involving 800 heart-eligible brain-dead organ donors requiring vasopressors.
- Donors randomly assigned to receive intravenous thyroxine or saline placebo for at least 12 hours.
- Primary outcomes include the proportion of hearts transplanted and non-inferior cardiac function; secondary outcomes include time to hemodynamic stability and ejection fraction.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This large-scale randomized controlled study is designed to definitively assess thyroid hormone's role in organ donor management.
- Findings will clarify whether intravenous thyroxine enhances heart transplant rates and provides hemodynamic benefits.
- Collaboration across organ procurement organizations ensures adequate donor enrollment and statistical power.
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 h or saline placebo. The primary study hypotheses are that thyroxine treatment will result in a higher proportion of hearts transplanted and that these hearts will have non-inferior function to hearts not treated with thyroxine. Additional outcome measures are the 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 in 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 intravenous thyroxine treatment increases hearts transplanted and/or provides hemodynamic benefits for donor management.
Trial Registration:
ClinicalTrials.gov NCT04415658 . Registered on June 4, 2020.
