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NCT Number: NCT04415658

Intravenous Thyroxine for Heart-Eligible Organ Donors

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

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Key information

Conditions

Brain Death Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Heart Diseases Heart Failure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

14 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Donor Network of Arizona, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Thyroxine

Drug

Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.

Saline

Drug

The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.

Primary outcomes

  1. Heart Transplanted

    Time frame: One week

    Whether heart is transplanted into living recipient

  2. Graft Function

    Time frame: 30 days

    30-day graft survival of hearts transplanted from study donors, obtained from SRTR recipient registry

Secondary outcomes

  1. Time Till Off Vasopressors

    Time frame: 72 hours

    Time in hours from randomization to when weaned off vasopressors (except vasopressin)

  2. Weaned Off Vasopressors

    Time frame: 12 hours

    Weaned off vasopressors within twelve hours

  3. Time to Order Echo

    Time frame: 72 hours

    Time till hemodynamic stability permits ordering initial echocardiogram

  4. Ejection Fraction

    Time frame: 72 hours

    Left ventricular ejection fraction measured on first echocardiography

  5. Lungs Transplanted

    Time frame: 72 hours

    Whether the lungs were transplanted into a living recipient

Other outcomes

  1. Total Organs Transplanted

    Time frame: One week

    Total number of organs transplanted (incl. lungs, liver, kidneys, heart, pancreas)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Mid-America Transplant

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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