Single-ventriclePhase 2/3CPFPNCT03575572
Colchicine in Postoperative Fontan Patients
A Phase 2/3 study testing Colchicine in people with Single-ventricle and Heart Diseases, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 months to 5 years
- Conditions the study is for
- Single-ventricle, Heart Diseases
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 13 Jan 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Single-ventricle, Heart Diseases
- Being tested
- Colchicine
- Keywords
- Fontan, Colchicine, heart surgery
- Medical subject headings
- Univentricular Heart, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Hospital discharge at study completion, approximately 2 weeks after surgery
Difference in Hospital Length of Stay
Measured in days compared to historical controls
Measured: Hospital discharge at study completion, approximately 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start29 Aug 2018
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
Why it stopped: Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Single-ventricleStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Goldstein, University of Michigan
- Investigators
- Stephanie Goldstein, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575572
- Sponsor's protocol ID
- HUM00143571
- Acronym
- CPFP
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2018
- Last updated
- 9 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39625244
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Postoperative Fontan Patients (CPFP)
- ClinicalTrials.gov ID
- NCT03575572
- Acronym / sponsor ID
- CPFP / HUM00143571
- Conditions
- Single-ventricle, Heart Diseases
- Keywords
- Fontan, Colchicine, heart surgery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staffing changes impacted by COVID-19 pandemic resulting in inadequate personnel to facilitate study.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Posted 9 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: ColchicineColchicine 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. |
Who may qualify
- Ages
- 20 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 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. | Drug | Colchicine |
Primary outcome
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine
Time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.
Difference in Change of Cytokine Concentrations in Pleural Fluid Patients Treated With Colchicine Compared to Historical Controls
Time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery
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
6 secondary outcomes
Cytokine Total Mass as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Time frame: 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
Time frame: Postoperative days 1, 2, 3, 4, 7, 10
Duration of Pleural Drainage as Measured in Postoperative Fontan Patients Treated Empirically With Colchicine
Time frame: 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
Time frame: 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
Time frame: Hospital discharge at study completion, approximately 2 weeks after surgery
Difference in Hospital Length of Stay
Time frame: Hospital discharge at study completion, approximately 2 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39625244Goldstein 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Goldstein, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Colchicine in people with Single-ventricle and Heart Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cytokine Total Mass in Pleural Fluid From Patients Treated With Colchicine (time frame: Postoperative day 1 ; day most distal from surgery, approximately 7 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.