CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 838 enrolled
Drug / intervention
Thyroxine +1 moredrug
Likely dose
Thyroxine 500 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04415658
NCT04415658Phase 3Completed
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A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors

Washington University School of Medicine·interventional·Posted Jun 4, 2020·Updated Jan 10, 2024

In Brief

A Phase 3 clinical trial evaluating Thyroxine and Saline for Brain Death and Heart Failure. Completed, enrolled 838 participants across 14 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Death, Heart Failure
CountriesUnited States
CollaboratorsMid-America Transplant

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartDec 1, 2020
Primary CompletionNov 6, 2022
Study CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.1 years ago

Interventions

Thyroxinedrug

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.

Salinedrug

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.