← Back to Search

Thyroid Hormone Replacement

Thyroxine for Brain Death

Phase 3

Waitlist Available

Led By Rajat Dhar, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Declared dead by neurologic criteria (brain dead)

Authorization for organ donation and research

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial will test whether giving thyroxine to brain-dead organ donors who are eligible to donate hearts will result in more hearts being transplanted than if they were given a placebo.

Eligible Conditions

Brain Death
Heart Failure

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Graft Function

Heart Transplanted

Secondary outcome measures

Ejection Fraction

Lungs Transplanted

Time Till Off Vasopressors

+2 more

Other outcome measures

Total Organs Transplanted

Side effects data

From 2022 Phase 3 trial • 838 Patients • NCT04415658

Hypertension

Tachycardia

Atrial fibrillation

Ventricular ectopy

Ventricular tachycardia

Misc/Other

100%

80%

60%

40%

20%

Study treatment Arm

Thyroxine

Saline Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ThyroxineExperimental Treatment1 Intervention

Intravenous thyroxine infusion

Group II: Saline PlaceboPlacebo Group1 Intervention

Intravenous saline infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thyroxine

2020

Completed Phase 3

~1270

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mid-America TransplantOTHER

5 Previous Clinical Trials

887 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,929 Previous Clinical Trials

2,297,118 Total Patients Enrolled

1 Trials studying Brain Death

199 Patients Enrolled for Brain Death

Rajat Dhar, MDPrincipal Investigator - Washington University School of Medicine

Washington University

Mc Master University (Medical School)

2 Previous Clinical Trials

211 Total Patients Enrolled

1 Trials studying Brain Death

199 Patients Enrolled for Brain Death

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you share any other examples of research done on Thyroxine's effectiveness?

"University Sleep Disorders Center first began studying thyroxine in 2011 and, to date, 498 clinical trials have completed. There are 11 live trials currently, with a large concentration in Westwood, Kansas."

Answered by AI

Does Thyroxine have any dangerous side effects?

"Because this is a Phase 3 trial, there is available data that suggests Thyroxine is effective and safe. Our team has given it a score of 3."

Answered by AI

How many sites are administering this trial?

"To avoid undue hardship, researchers recommend that potential participants select a clinical trial site that is close to their home. There are presently 12 different sites enrolling patients for this study, which are located in Westwood, North Liberty, San Diego, and other cities."

Answered by AI

What is the main aim of this research project?

"The primary metric of success for this trial, which will last for approximately one week, is Graft function. Additionally, the study will measure Time till off vasopressors, Time to order echo, and Ejection fraction as secondary outcomes."

Answered by AI

Are we still recruiting for this research project?

"The clinicaltrials.gov website indeed contains information stating that this study is looking for subjects right now. The posting date was December 1, 2020 with the most recent edit on November 22, 2021. They are aiming to enroll 800 people total at 12 different locations."

Answered by AI

What are some popular applications for Thyroxine?

"Clinicians can prescribe Thyroxine to patients suffering from malignant neoplasms, euthyroid goitre, and adiposity."

Answered by AI

Does the age limit for this research exclude people over 75 years old?

"This trial is only for people aged 14 to 55. There are 26 other trials that test this medication on children and 732 trials testing this medication on senior citizens."

Answered by AI

Recent research and studies

Clinical TransplantationJournal

A Randomized Trial Comparing Triiodothyronine (T3) with Thyroxine (T4) for Hemodynamically Unstable Brain‐dead Organ Donors

Dhar, Rajat, Emily Stahlschmidt, Yan Yan, and Gary Marklin. 2019. “A Randomized Trial Comparing Triiodothyronine (T3) with Thyroxine (T4) for Hemodynamically Unstable Brain‐dead Organ Donors”. Clinical Transplantation. Wiley. doi:10.1111/ctr.13486.

Progress in TransplantationJournal

A Randomized Trial of Intravenous Thyroxine for Brain-dead Organ Donors with Impaired Cardiac Function

Dhar, Rajat, Emily Stahlschmidt, and Gary Marklin. 2019. “A Randomized Trial of Intravenous Thyroxine for Brain-dead Organ Donors with Impaired Cardiac Function”. Progress in Transplantation. SAGE Publications. doi:10.1177/1526924819893295.

TrialsJournal

A Multicenter Randomized Placebo-controlled Trial of Intravenous Thyroxine for Heart-eligible Brain-dead Organ Donors

Dhar, Rajat, Dean Klinkenberg, and Gary Marklin. 2021. “A Multicenter Randomized Placebo-controlled Trial of Intravenous Thyroxine for Heart-eligible Brain-dead Organ Donors”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05797-2.

clinicaltrials.govStudy