Study Stopped
Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.
Colchicine in Postoperative Fontan Patients
CPFP
1 other identifier
interventional
11
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 2, 2018
CompletedStudy Start
First participant enrolled
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 13, 2021
CompletedResults Posted
Study results publicly available
May 9, 2022
CompletedMay 9, 2022
April 1, 2022
2.4 years
June 18, 2018
February 28, 2022
April 12, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
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
Postoperative days 1, 2, 3, 4, 7, 10
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
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
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
Hospital discharge at study completion, approximately 2 weeks after surgery
- +1 more secondary outcomes
Study Arms (1)
Colchicine
EXPERIMENTALColchicine 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Related Publications (1)
Goldstein SA, Nolan K, Marchetti K, Stoscup JK, Clewis H, Jarvis K, Halligan NLN, Dahmer MK, Schumacher KR, Rocchini A. Colchicine in post-operative Fontan patients. Cardiol Young. 2023 Jun;33(6):910-916. doi: 10.1017/S104795112200186X. Epub 2022 Jun 20.
PMID: 39625244DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Goldstein
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Goldstein, MD
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- House Officer, Pediatric Cardiology and House Officer, Pediatric Critical Care (during active trial status)
Study Record Dates
First Submitted
June 18, 2018
First Posted
July 2, 2018
Study Start
August 29, 2018
Primary Completion
January 13, 2021
Study Completion
January 13, 2021
Last Updated
May 9, 2022
Results First Posted
May 9, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share