Colchicine in Postoperative Fontan Patients



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any - 5
Updated:9/19/2018
Start Date:August 29, 2018
End Date:June 2020
Contact:Christina Munoz
Email:cpmunoz@med.umich.edu
Phone:734-615-1903

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Trial Summary
Trial Overview
Inclusion Criteria

Colchicine in Postoperative Fontan Patients (CPFP)

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.


Inclusion Criteria:

- Ages 24 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)
We found this trial at
1
site
University of Michigan
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Stephanie Goldstein, MD
Phone: 734-615-1903
University of Michigan The University of Michigan was founded in 1817 as one of the...
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mi
from
Ann Arbor, MI
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