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NCT02498444 · ClinicalTrials.gov registry record · NA
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
A NA study, sponsored by Stanford University.
- Terminated
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT02498444: Clinical Trial NA study, sponsored by Stanford University.
NCT02498444 is a NA study that was terminated before completion, run by Stanford University. The registered enrollment target is 34 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02498444, a NA study, was terminated before completion, sponsored by Stanford University.
- TERMINATED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days). The Fontan operation is performed for patients with single ventricle physiology as the final palliation to create a series circulation, with passive systemic venous return to the pulmonary arteries and the single ventricle solely providing systemic output. Patients undergoing extracardiac Fontan tend to have elevation of Fontan pressures immediately following the operation with inflammation from surgery requiring additional fluid administration to maintain blood pressure. Increased Fontan pressures and fluid overload lead to prolonged chest tube drainage. The hypothesis is that treprostinil, a prostacyclin drug that dilates the pulmonary arteries, will improve immediate postoperative Fontan pressures. Treprostinil is not FDA approved for this use. Anecdotally and in a small case series, prostacyclin therapy has been shown to assist in transitioning patients off nitric oxide. The investigators believe that this improvement in hemodynamics will decrease duration of chest tube drainage resulting in a shorter length of hospital stay.
Primary Outcome
This outcome measures the number of days that chest tubes were in place postoperatively.
Interventions
- DRUG Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-12 |
| Phase | NA |
Why NCT02498444 stopped before completion
NCT02498444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Treprostinil is the first listed.
NCT02498444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02498444 about?
NCT02498444 is a clinical study titled "Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation". The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days). The Fontan operation is performed for patients with single ventricle physiology as the final palli...
What is the current status of trial NCT02498444?
This trial is currently terminated. It is a NA study. The enrollment target is 34 participants. The study started on 2015-09. Estimated completion is 2020-12.
What interventions are being tested in trial NCT02498444?
The interventions under investigation include: Treprostinil (DRUG).
Who is sponsoring clinical trial NCT02498444?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02498444's enrollment target sits among peer trials
34 1570th of 2000 higher than 427 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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