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Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Goldstein, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39625244 | Derived | 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. |
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2 people who were consented didn't actually begin the trial. Under the protocol, historical controls were not considered enrolled in this study, so they are not included in participant flow. Historical control data were taken from an observational study with no intervention that was published prior to first enrollment in this trial. Data on the historical controls are available at PMID: 30710164.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colchicine | All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Colchicine | All patients entered the intended protocol where Colchicine was empirically given 0.6mg once daily to postoperative Fontan patients starting on postoperative day 2 and ending 1 day after chest tubes were removed or for a maximum of 4 weeks. |
| BG001 | Historical Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | picograms | Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery |
|
|
from initiation of study through 5-14 days after last dose of colchicine (generally 12 -21 days)
As noted earlier under Participant Flow, historical controls were not considered enrolled in this trial. Further, the historical control information comes from an observational study in which Adverse Events were not collected. Thus, historical control data is not presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Goldstein | University of Utah | 801 587-7572 | stephanie.goldstein@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2020 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000080039 | Univentricular Heart |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
| 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 |
Historical Controls were post-operative Fontan patients who underwent their operation at the University of Michigan. They were part of a prospective observational study that was published in 2019 which included the chest tube drainage sample collection similar to that done with the Colchicine cohort in this trial. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Diagnosis | Number | participants |
|
| Participants |
|
|
| Primary | 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 | Posted | Median | Inter-Quartile Range | picograms | Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | picograms | Postoperative days 1, 2, 3, 4, 7 |
|
|
|
| Secondary | 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 | Day 10 data was not gathered from participants per protocol, but it was available for historical controls. | Posted | Median | Inter-Quartile Range | picograms | Postoperative days 1, 2, 3, 4, 7, 10 |
|
|
|
| Secondary | 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. | Intention to Treat compared to colchicine per protocol | Posted | Median | Inter-Quartile Range | days | Date of chest tube drainage discontinuation, approximately 11 days after surgery |
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | days | Date of chest tube drainage discontinuation, approximately 11 days after surgery |
|
|
|
|
| Secondary | 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 | Posted | Median | Inter-Quartile Range | days | Hospital discharge at study completion, approximately 2 weeks after surgery |
|
|
|
| Secondary | Difference in Hospital Length of Stay | Measured in days compared to historical controls | Posted | Median | Inter-Quartile Range | days | Hospital discharge at study completion, approximately 2 weeks after surgery |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 9 |
| 9 |
| increase in creatinine | Renal and urinary disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| hepatic dysfunction | Hepatobiliary disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| loose stool | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| TNF-Alpha Day 1 |
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| TNF-ALpha Day 7 |
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| MIP-1 Beta Day 1 |
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| MIP-1Beta Day 7 |
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| IL-10, Day 1 |
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| IL-10, Day 7 |
|
| Title | Measurements |
|---|---|
|
| IL 8 Day 4 |
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| IL 8 Day 7 |
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| IL 10 Day 1 |
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| IL 10 Day 2 |
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| IL 10 Day 3 |
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| IL 10 Day 4 |
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| IL 10 Day 7 |
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| TNF Alpha Day 1 |
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| TNF Alpha Day 2 |
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| TNF Alpha Day 3 |
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| TNF Alpha Day 4 |
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| TNF Alpha Day 7 |
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| MIP-1 Beta Day 1 |
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| MIP-1 Beta Day 2 |
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| MIP-1 Beta Day 3 |
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| MIP-1 Beta Day 4 |
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| MIP-1 Beta Day 7 |
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| IL-8 Day 2 |
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| IL-8 Day 3 |
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| IL-8 Day 4 |
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| IL-8 Day 7 |
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| IL-8 Day 10 |
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| IL-10 Day 1 |
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| IL-10 Day 2 |
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| IL-10 Day 3 |
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| IL-10 Day 4 |
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| IL-10 Day 7 |
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| IL-10 Day 10 |
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| TNF Alpha Day 1 |
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| TNF Alpha Day 2 |
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| TNF Alpha Day 3 |
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| TNF Alpha Day 4 |
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| TNF Alpha Day 7 |
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| TNF Alpha Day 10 |
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| MIP-Beta Day 1 |
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| MIP-Beta Day 2 |
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| MIP-Beta Day 3 |
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| MIP-Beta Day 4 |
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| MIP-Beta Day 7 |
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| MIP-Beta Day 10 |
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| Superiority |
| Superiority |