Colchicine in Postoperative Fontan Patients (CPFP)

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.

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Single-ventricle
• Intervention / Treatment: Drug: Colchicine

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine	Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.	Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls	Difference is shown via two columns of separate data, but given that enrollment didn't meet target before termination statistical analysis was not done for this measure	Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Particularly Cytokine total mass of TNF-α, MIP-1β, IL-8, and IL-10, determined by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay Data was only collected while patients had chest tubes in place (up to 7 days only)	Postoperative days 1, 2, 3, 4, 7
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients	Cytokine total mass measured by Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay Data was only collected from Colchicine patients while they had chest tubes in place (up to 7 days). For historical controls data was collected up through Day 10	Postoperative days 1, 2, 3, 4, 7, 10
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation.	Date of chest tube drainage discontinuation, approximately 11 days after surgery
Difference of Duration of Pleural Drainage of Two Groups, in Empiric Treatment With Colchicine Compared to a Cohort of Fontan Patients Not Treated With Colchicine	Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation	Date of chest tube drainage discontinuation, approximately 11 days after surgery
Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine	Measured in days, from date of Fontan surgery to chest tube drainage discontinuation	Hospital discharge at study completion, approximately 2 weeks after surgery
Difference in Hospital Length of Stay	Measured in days compared to historical controls	Hospital discharge at study completion, approximately 2 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Stephanie Goldstein, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): January 13, 2021
• Study Completion (Actual): January 13, 2021

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Fontan; Colchicine; heart surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Univentricular Heart; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: HUM00143571

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No