Colchicine in Postoperative Fontan Patients (CPFP)

University of Michigan

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Single-ventricle; Heart Diseases

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT03575572

HUM00143571

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 20 months to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Colchicine

Experimental group

Description:

Colchicine will be given at 0.6 mg once daily for the duration of chest tube output plus 24 hours after chest tube removal with a maximum of 4 weeks duration.

Treatment:

Drug: Colchicine