Colchicine in Postoperative Fontan Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2021-01-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Single-ventricle Heart Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Colchicine

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.

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No