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Intravenous Thyroxine for Heart-Eligible Organ Donors

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ClinicalTrials.gov Identifier: NCT04415658
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Mid-America Transplant
Information provided by (Responsible Party):
Rajat Dhar, Washington University School of Medicine

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 transplanted than saline placebo

Condition or disease Intervention/treatment Phase
Brain Death Heart Failure Drug: Thyroxine Drug: Saline Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Thyroxine
Intravenous thyroxine infusion
Drug: 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.

Placebo Comparator: Saline Placebo
Intravenous saline infusion
Drug: 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.




Primary Outcome Measures :
  1. Heart transplanted [ Time Frame: One week ]
    Whether heart is transplanted into living recipient

  2. Graft function [ Time Frame: 30 days ]
    30-day graft survival of hearts transplanted from study donors


Secondary Outcome Measures :
  1. Time till off vasopressors [ Time Frame: 72 hours ]
    Time in hours from randomization to when weaned off vasopressors (except vasopressin)

  2. Weaned off vasopressors [ Time Frame: 12 hours ]
    Weaned off vasopressors within twelve hours

  3. Time to order echo [ Time Frame: 72 hours ]
    Time till hemodynamic stability permits ordering initial echocardiogram

  4. Ejection fraction [ Time Frame: 72 hours ]
    Left ventricular ejection fraction measured on first echocardiography


Other Outcome Measures:
  1. Total organs transplanted [ Time Frame: One week ]
    Total number of organs transplanted



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Ages Eligible for Study:   14 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04415658


Contacts
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Contact: Gary Marklin, MD 314-735-8291 gmarklin@midamericatransplant.org
Contact: Coby O'Sullivan 3147358200 cosullivan@midamericatransplant.org

Locations
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United States, Arizona
Donor Network of Arizona Recruiting
Phoenix, Arizona, United States, 85013
Contact: PJ Geraghty    602-222-2482    PJ@dnaz.org   
Contact: Kayla Grey, CCRP    602 222-2258    kayla.gray@dnaz.org   
United States, California
Lifesharing Recruiting
San Diego, California, United States, 92108
Contact: Jeff Trageser, MSN, RN    619-543-4961    jtrageser@health.ucsd.edu   
Contact: Jaclyn Russe       jrusse@health.ucsd.edu   
United States, Colorado
Donor Alliance Recruiting
Denver, Colorado, United States, 80230
Contact: Jay Ruterbories, CPTC, CTBS    303-329-4747    jruterbories@donoralliance.org   
United States, Florida
OurLegacy Recruiting
Maitland, Florida, United States, 32751
Contact: Laura Huckestein       Laura.Huckestein@OurLegacyFL.org   
Contact: Tiffany Staman       tiffany.staman@ourlegacyfl.org   
United States, Iowa
Iowa Donor Network Recruiting
North Liberty, Iowa, United States, 52317
Contact: Meghan Stephenson, RN, MSN       mstephenson@iadn.org   
Contact: Briann Davis       bdavis@iadn.org   
United States, Kansas
Midwest Transplant Network Recruiting
Westwood, Kansas, United States, 66205
Contact: Melissa Ott       mott@mwtn.org   
Contact: Scott Sander    913-261-7303    ssander@mwtn.org   
United States, Louisiana
Louisiana Organ Procurement Agency Recruiting
Covington, Louisiana, United States, 70433
Contact: Joey Boudreaux    504-837-3355 ext 288    jboudreaux@lopa.org   
Contact: Tina Madere    504 606-0689    tmadere@lopa.org   
United States, Missouri
Mid-America Transplant Services Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gary Marklin, MD    314-735-8291    gmarklin@midamericatransplant.org   
United States, Ohio
Lifebanc Recruiting
Cleveland, Ohio, United States, 44128
Contact: Kimberly Goss    216-408-6092    KimberlyG@lifebanc.org   
Contact: Dan Lebovitz, MD         
United States, Oklahoma
LifeShare of Oklahoma Terminated
Oklahoma City, Oklahoma, United States, 73132
United States, Texas
Southwest Transplant Alliance Recruiting
Dallas, Texas, United States, 75231
Contact: Sean Forquer    214-522-0255    sforquer@organ.org   
Contact: Erin Vines       evines@organ.org   
Texas Organ Sharing Alliance Recruiting
San Antonio, Texas, United States, 78229
Contact: Sarah Dworaczyk    210-614-7030    sdworaczyk@tosa1.org   
Contact: Micah Williams    512-757-6011    MWilliams@tosa1.org   
United States, Utah
DonorConnect Active, not recruiting
Murray, Utah, United States, 84107
United States, Washington
LifeCenter Northwest Active, not recruiting
Bellevue, Washington, United States, 98006
Sponsors and Collaborators
Washington University School of Medicine
Mid-America Transplant
Investigators
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Principal Investigator: Rajat Dhar, MD Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Rajat Dhar, Washington University School of Medicine:
Study Protocol: Appendix (Data Forms)  [PDF] December 1, 2020
Study Protocol: Main Study Protocol  [PDF] December 1, 2020

Publications:
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Responsible Party: Rajat Dhar, Associate Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04415658    
Other Study ID Numbers: ODRC-002
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rajat Dhar, Washington University School of Medicine:
Organ donor
Additional relevant MeSH terms:
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Brain Death
Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes