NCT03575572

Colchicine in Postoperative Fontan Patients

Colchicine in Postoperative Fontan Patients (CPFP)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 20 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Single-ventricle
• Heart Diseases

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine is an alkaloid approved in 1961 for the use in Familial Mediterranean Fever in adults and children 4 years of age or older. It has been widely used for decades in other indications, such as Gout, recurrent pericarditis, pericardial effusions and other inflammatory diseases. This drug is commercially available and is approved in children 4 years and older.

Timeline

• Start date: 2018-08-29
• Primary completion: 2021-01-13
• Completion: 2021-01-13
• First posted: 2018-07-02
• Last updated: 2022-05-09
• Results posted: 2022-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study