Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
838 participants
INTERVENTIONAL
2020-12-01
2022-12-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thyroxine
Intravenous thyroxine infusion
Thyroxine
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 Placebo
Intravenous saline infusion
Saline
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.
Interventions
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Thyroxine
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
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.
Eligibility Criteria
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Inclusion Criteria
* Authorization for organ donation and research
* On one or more vasopressors and/or inotropes
Exclusion Criteria
* 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)
14 Years
55 Years
ALL
No
Sponsors
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Mid-America Transplant
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Rajat Dhar
Professor
Principal Investigators
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Rajat Dhar, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Donor Network of Arizona
Phoenix, Arizona, United States
Lifesharing
San Diego, California, United States
Donor Alliance
Denver, Colorado, United States
OurLegacy
Maitland, Florida, United States
Iowa Donor Network
North Liberty, Iowa, United States
Midwest Transplant Network
Westwood, Kansas, United States
Louisiana Organ Procurement Agency
Covington, Louisiana, United States
Mid-America Transplant Services
St Louis, Missouri, United States
Lifebanc
Cleveland, Ohio, United States
LifeShare of Oklahoma
Oklahoma City, Oklahoma, United States
Southwest Transplant Alliance
Dallas, Texas, United States
Texas Organ Sharing Alliance
San Antonio, Texas, United States
DonorConnect
Murray, Utah, United States
LifeCenter Northwest
Bellevue, Washington, United States
Countries
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References
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Dhar R, Stahlschmidt E, Yan Y, Marklin G. A randomized trial comparing triiodothyronine (T3) with thyroxine (T4) for hemodynamically unstable brain-dead organ donors. Clin Transplant. 2019 Mar;33(3):e13486. doi: 10.1111/ctr.13486. Epub 2019 Feb 12.
Dhar R, Stahlschmidt E, Marklin G. A Randomized Trial of Intravenous Thyroxine for Brain-Dead Organ Donors With Impaired Cardiac Function. Prog Transplant. 2020 Mar;30(1):48-55. doi: 10.1177/1526924819893295. Epub 2019 Dec 5.
Dhar R, Marklin GF, Klinkenberg WD, Wang J, Goss CW, Lele AV, Kensinger CD, Lange PA, Lebovitz DJ. Intravenous Levothyroxine for Unstable Brain-Dead Heart Donors. N Engl J Med. 2023 Nov 30;389(22):2029-2038. doi: 10.1056/NEJMoa2305969.
Dhar R, Klinkenberg D, Marklin G. A multicenter randomized placebo-controlled trial of intravenous thyroxine for heart-eligible brain-dead organ donors. Trials. 2021 Nov 27;22(1):852. doi: 10.1186/s13063-021-05797-2.
Provided Documents
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Document Type: Study Protocol: Appendix (Data Forms)
Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol and SAP
Other Identifiers
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ODRC-002
Identifier Type: -
Identifier Source: org_study_id
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