Intravenous Thyroxine for Heart-Eligible Organ Donors

The Washington University

Status and phase: Completed; Phase 3

Conditions: Heart Failure; Brain Death

Treatments: Drug: Saline; Drug: Thyroxine

Study type: Interventional

Funder types: Other

Identifiers

NCT04415658

ODRC-002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 838 patients

Sex: All

Ages: 14 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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838 participants in 2 patient groups, including a placebo group

Thyroxine

Experimental group

Description:

Intravenous thyroxine infusion

Treatment:

Drug: Thyroxine

Saline Placebo

Placebo Comparator group

Description:

Intravenous saline infusion

Treatment:

Drug: Saline