Trial Outcomes & Findings for Colchicine in Postoperative Fontan Patients (NCT NCT03575572)
NCT ID: NCT03575572
Last Updated: 2022-05-09
Results Overview
Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
11 participants
Primary outcome timeframe
Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Results posted on
2022-05-09
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Colchicine in Postoperative Fontan Patients
Baseline characteristics by cohort
| Measure |
Colchicine
n=9 Participants
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.
|
Historical Controls
n=25 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2.7 years
n=5 Participants
|
2.5 years
n=7 Participants
|
NA years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
25 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Primary Diagnosis
Hypoplastic left heart syndrome (HLHS)
|
6 participants
n=5 Participants
|
14 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Primary Diagnosis
Not HLHS
|
3 participants
n=5 Participants
|
11 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgeryCytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
IL-10 Day 7
|
132.755 picograms
Interval 117.558 to 147.953
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Interleukin (IL)-8; post op. Day 1
|
60925.8 picograms
Interval 27396.7 to 123151.56
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
IL-8, Day 7
|
8684.57 picograms
Interval 2346.135 to 19715.275
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Tumor Necrosis Factor (TNF)-alpha, Day 1
|
6552.7 picograms
Interval 4954.77 to 7482.8
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
TNF-alpha, Day 7
|
694.575 picograms
Interval 479.288 to 909.863
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Macrophage Inflammatory Protein (MIP)-1 Beta Day 1
|
4949.89 picograms
Interval 4450.56 to 13543.4
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
MIP-1 Beta Day 7
|
247.775 picograms
Interval 225.088 to 270.463
|
—
|
—
|
|
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Interleukin (IL)-10 Day 1
|
5286.55 picograms
Interval 4560.4 to 9763.27
|
—
|
—
|
PRIMARY outcome
Timeframe: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgeryDifference 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
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=25 Participants
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
MIP-1 Beta Day 1
|
4949.89 picograms
Interval 4450.56 to 13543.4
|
11527.80 picograms
Interval 6800.6 to 18611.9
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
IL-8 Day 1
|
60925.80 picograms
Interval 27396.7 to 123151.56
|
83263.45 picograms
Interval 42239.05 to 369274.25
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
IL-8 Day 7
|
8684.57 picograms
Interval 2346.14 to 19715.28
|
64695.50 picograms
Interval 28829.24 to 253569.74
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
TNF-Alpha Day 1
|
6552.70 picograms
Interval 4954.77 to 7482.8
|
8080.38 picograms
Interval 6269.6 to 11148.0
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
TNF-ALpha Day 7
|
694.575 picograms
Interval 479.288 to 909.863
|
3320.97 picograms
Interval 1872.72 to 5481.28
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
MIP-1Beta Day 7
|
247.775 picograms
Interval 225.088 to 270.463
|
5986.4 picograms
Interval 3251.41 to 12216.24
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
IL-10, Day 1
|
5286.55 picograms
Interval 4560.4 to 9763.27
|
14474.4 picograms
Interval 8099.82 to 25592.7
|
—
|
|
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
IL-10, Day 7
|
132.755 picograms
Interval 117.558 to 147.953
|
885.04 picograms
Interval 693.12 to 1665.66
|
—
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7Particularly 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)
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 10 Day 7
|
132.755 picograms
Interval 117.558 to 147.953
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL-8 Day 1
|
60925.80 picograms
Interval 27396.7 to 123151.56
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 8 Day 2
|
22178.00 picograms
Interval 11356.16 to 57721.6
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 8 Day 3
|
26837.20 picograms
Interval 15517.8 to 80660.56
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 8 Day 4
|
50895.36 picograms
Interval 17402.06 to 113591.7
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 8 Day 7
|
8684.57 picograms
Interval 2346.14 to 19715.28
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 10 Day 1
|
5286.55 picograms
Interval 4560.4 to 9763.27
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 10 Day 2
|
2788.44 picograms
Interval 2194.92 to 3084.9
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 10 Day 3
|
586.50 picograms
Interval 401.6 to 1033.6
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
IL 10 Day 4
|
448.06 picograms
Interval 318.24 to 593.46
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
TNF Alpha Day 1
|
6552.70 picograms
Interval 4954.77 to 7482.8
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
TNF Alpha Day 2
|
6220.50 picograms
Interval 2854.3 to 6932.6
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
TNF Alpha Day 3
|
3791.84 picograms
Interval 2108.68 to 4360.8
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
TNF Alpha Day 4
|
2517.90 picograms
Interval 1248.72 to 2950.66
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
TNF Alpha Day 7
|
694.575 picograms
Interval 479.288 to 909.863
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
MIP-1 Beta Day 1
|
4949.89 picograms
Interval 4450.56 to 13543.4
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
MIP-1 Beta Day 2
|
3066.80 picograms
Interval 2566.1 to 10702.9
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
MIP-1 Beta Day 3
|
4031.04 picograms
Interval 2107.66 to 6968.0
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
MIP-1 Beta Day 4
|
2730.50 picograms
Interval 2327.64 to 5768.16
|
—
|
—
|
|
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
MIP-1 Beta Day 7
|
247.775 picograms
Interval 225.088 to 270.463
|
—
|
—
|
SECONDARY outcome
Timeframe: Postoperative days 1, 2, 3, 4, 7, 10Population: Day 10 data was not gathered from participants per protocol, but it was available for historical controls.
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
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=25 Participants
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 1
|
60925.80 picograms
Interval 27396.7 to 123151.56
|
83263.45 picograms
Interval 42239.05 to 369274.25
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 4
|
50895.36 picograms
Interval 17402.06 to 113591.7
|
52203.825 picograms
Interval 21544.8 to 142966.54
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 2
|
2788.440 picograms
Interval 2194.92 to 3084.9
|
5341.80 picograms
Interval 2882.88 to 9084.43
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 3
|
3791.84 picograms
Interval 2108.68 to 4360.8
|
3495.45 picograms
Interval 2314.73 to 5610.04
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 3
|
4031.04 picograms
Interval 2107.66 to 6968.0
|
6594.00 picograms
Interval 3215.19 to 8202.6
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 2
|
22178.00 picograms
Interval 11356.16 to 57721.6
|
50734.56 picograms
Interval 20064.46 to 177356.64
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 3
|
26837.20 picograms
Interval 15517.8 to 80660.56
|
36175.15 picograms
Interval 14641.888 to 95957.95
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 7
|
8684.57 picograms
Interval 2346.14 to 19715.28
|
64695.5 picograms
Interval 28829.24 to 253569.74
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-8 Day 10
|
—
|
140165.900 picograms
Interval 28829.24 to 253569.74
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 1
|
5286.55 picograms
Interval 4560.4 to 9763.27
|
14474.4 picograms
Interval 8099.82 to 25592.7
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 3
|
586.59 picograms
Interval 401.6 to 1033.6
|
1192.29 picograms
Interval 914.91 to 3959.96
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 4
|
448.06 picograms
Interval 318.24 to 593.46
|
1462.22 picograms
Interval 645.84 to 2533.72
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 7
|
132.755 picograms
Interval 117.558 to 147.953
|
885.04 picograms
Interval 693.12 to 1665.66
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
IL-10 Day 10
|
—
|
417.80 picograms
Interval 397.7 to 879.52
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 1
|
6552.70 picograms
Interval 4954.77 to 7482.8
|
8080.38 picograms
Interval 6269.6 to 11148.0
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 2
|
6220.50 picograms
Interval 2854.3 to 6932.6
|
4761.36 picograms
Interval 3666.3 to 8852.98
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 4
|
2517.90 picograms
Interval 1248.72 to 2950.66
|
3411.555 picograms
Interval 1894.673 to 6369.735
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 7
|
694.575 picograms
Interval 479.288 to 909.863
|
3320.97 picograms
Interval 1872.72 to 5481.28
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
TNF Alpha Day 10
|
—
|
2361.60 picograms
Interval 1741.88 to 3880.69
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 1
|
4949.89 picograms
Interval 4450.56 to 13543.4
|
11527.80 picograms
Interval 6800.6 to 18611.9
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 2
|
3066.80 picograms
Interval 2566.1 to 10702.9
|
8822.96 picograms
Interval 5286.89 to 14864.72
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 4
|
2730.50 picograms
Interval 2327.64 to 5768.16
|
7375.96 picograms
Interval 2856.5 to 13588.94
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 7
|
247.775 picograms
Interval 225.088 to 270.463
|
5986.40 picograms
Interval 3251.41 to 12216.24
|
—
|
|
Difference in Cytokine Total Mass, as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine in Comparison to a Cohort of Postoperative Fontan Patients
MIP-Beta Day 10
|
—
|
8957.13 picograms
Interval 4132.15 to 17056.82
|
—
|
SECONDARY outcome
Timeframe: Date of chest tube drainage discontinuation, approximately 11 days after surgeryPopulation: Intention to Treat compared to colchicine per protocol
Duration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation.
Outcome measures
| Measure |
Colchicine Per Protocol
n=9 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=5 Participants
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
|
7.5 days
Interval 5.75 to 9.0
|
6 days
Interval 4.5 to 7.0
|
—
|
SECONDARY outcome
Timeframe: Date of chest tube drainage discontinuation, approximately 11 days after surgeryDuration is measured in days, from date of Fontan surgery to chest tube drainage discontinuation
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=9 Participants
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.
|
Historical Controls
n=25 Participants
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.
|
|---|---|---|---|
|
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
|
6 days
Interval 4.5 to 7.0
|
7.5 days
Interval 5.8 to 9.0
|
10 days
Interval 7.0 to 11.0
|
SECONDARY outcome
Timeframe: Hospital discharge at study completion, approximately 2 weeks after surgeryMeasured in days, from date of Fontan surgery to chest tube drainage discontinuation
Outcome measures
| Measure |
Colchicine Per Protocol
n=9 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=5 Participants
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.
|
Historical Controls
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.
|
|---|---|---|---|
|
Hospital Length of Stay as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
|
9 days
Interval 6.5 to 11.0
|
7 days
Interval 5.5 to 8.5
|
—
|
SECONDARY outcome
Timeframe: Hospital discharge at study completion, approximately 2 weeks after surgeryMeasured in days compared to historical controls
Outcome measures
| Measure |
Colchicine Per Protocol
n=5 Participants
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.
These participants completed the protocol.
|
Historical Controls
n=9 Participants
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.
|
Historical Controls
n=25 Participants
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.
|
|---|---|---|---|
|
Difference in Hospital Length of Stay
|
7 days
Interval 5.5 to 8.5
|
9 days
Interval 6.5 to 11.0
|
11 days
Interval 9.0 to 13.0
|
Adverse Events
Colchicine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine
n=9 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
nausea
|
55.6%
5/9 • 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.
|
|
Renal and urinary disorders
increase in creatinine
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
diarrhea
|
11.1%
1/9 • 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.
|
|
Hepatobiliary disorders
hepatic dysfunction
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
vomiting
|
55.6%
5/9 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
loose stool
|
11.1%
1/9 • 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.
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
1/9 • 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.
|
|
Skin and subcutaneous tissue disorders
rash
|
11.1%
1/9 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place