Status:
COMPLETED
Intravenous Thyroxine for Heart-Eligible Organ Donors
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Mid-America Transplant
Conditions:
Brain Death
Heart Failure
Eligibility:
All Genders
14-55 years
Phase:
PHASE3
Brief 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 transpl...
Detailed 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 be...
Eligibility Criteria
Inclusion
- Declared dead by neurologic criteria (brain dead)
- Authorization for organ donation and research
- On one or more vasopressors and/or inotropes
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
838 Patients enrolled
Trial Details
Trial ID
NCT04415658
Start Date
December 1 2020
End Date
December 6 2022
Last Update
January 10 2024
Active Locations (14)
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1
Donor Network of Arizona
Phoenix, Arizona, United States, 85013
2
Lifesharing
San Diego, California, United States, 92108
3
Donor Alliance
Denver, Colorado, United States, 80230
4
OurLegacy
Maitland, Florida, United States, 32751