Colchicine in Postoperative Fontan Patients

• Status: Terminated
• Trial end date: 2021-01-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Colchicine

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)