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NCT03575572 · ClinicalTrials.gov registry record · Phase 2

Colchicine in Postoperative Fontan Patients

A Phase 2 study, sponsored by University of Michigan.

Terminated
Registry status
Phase 2
Development phase
11
Enrollment target

NCT03575572: Clinical Trial Phase 2 study, sponsored by University of Michigan.

NCT03575572 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03575572, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.

TERMINATED
Registry status
Phase 2
Development phase
11 participants
Enrollment target

Study 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.

Primary Outcome

Cytokine total mass measured by the Bio-rad Bio-Plex ProHuman Cytokine 17-plex Assay.

Interventions

  • DRUG Colchicine

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2018-08-29
Est. Completion 2021-01-13
Phase Phase 2
University of Michigan

1,327 total trials

Why NCT03575572 stopped before completion

NCT03575572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Colchicine is the first listed.

NCT03575572 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03575572 about?

NCT03575572 is a clinical study titled "Colchicine in Postoperative Fontan Patients". 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 d...

What is the current status of trial NCT03575572?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2018-08-29. Estimated completion is 2021-01-13.

What interventions are being tested in trial NCT03575572?

The interventions under investigation include: Colchicine (DRUG).

Who is sponsoring clinical trial NCT03575572?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03575572's enrollment target sits among peer trials

11 1967th of 2000 higher than 33 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03575572, the US trial registry maintained by the National Library of Medicine. NCT03575572 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.