Ann Arbor, Michigan 48109

  • Heart Diseases

Purpose:

The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the inflammation in the chest tube drainage after the Fontan operation, and can decrease the amount of time that patients having this surgery will have drainage.


Criteria:

Inclusion Criteria: - Ages 20 months to 5 years and 364 days are eligible - Diagnosed with single ventricle heart disease requiring Fontan palliation - Undergoing Fontan palliation at the University of Michigan Congenital Heart Center - Ability to take oral or enteral medication Exclusion Criteria: - Treatment with another investigational drug within 3 months - Pre-existing myelosuppression or decreased bone marrow activity. - Current or recent treatment with certain drugs - Renal or hepatic impairment deemed by the study team - Conditions and/or post-operative complications that would increase risk to the patient such as mechanical support (ECMO) or issues in the intensive care unit (ICU)


NCT ID:

NCT03575572


Primary Contact:

Principal Investigator
Carolyn Vitale, MD
University of Michigan


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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