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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. 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.
Interventions
- DRUG Treprostinil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2015-09 |
| Est. Completion | 2020-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02498444
The ClinicalTrials.gov registry entry for NCT02498444 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Treprostinil is the first listed.
NCT02498444 reports 0 study locations.
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.
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