Trial · NCT02498444
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
NCT02498444, Not applicable, Terminated, Stanford University; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation. Trials, record NCT02498444. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02498444
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
- NCT number
- NCT02498444
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 34 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Single Ventricle
- Interventions
- Treprostinil
- First posted
- 2015-07-15
- Last updated
- 2022-03-31
- Results first posted
- 2022-03-31
- Limitations and caveats
- Early termination based on futility analysis performed prior to full study enrollment led to smaller number of subjects analyzed than initially outlined by power analysis.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chest Tube Duration | 2-3 wks | This outcome measures the number of days that chest tubes were in place postoperatively. |
| Secondary | Length of Hospital Stay | 2-3 wks | This outcome measures the hospital length of stays in days. |
| Secondary | Postoperative Fontan Pressure | postoperative hour 0, 12 and 24 | Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups |
| Secondary | Postoperative Atrial Pressure | postoperative hour 0, 12 and 24 | Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups |
| Secondary | Postoperative Transpulmonary Gradient | postoperative hour 0, 12 and 24 | Patient hemodynamics as measured by invasive postoperative lines were recorded and compared between groups. Transpulmonary pressure gradient is defined as the difference between mean pulmonary artery pressure and left atrial pressure (commonly estimated by a pulmonary artery wedge pressure). |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Chest Tube Duration | 2-3 wks | Intention to treat analysis based on study group assignment at randomization. | days | MEDIAN |
| SECONDARY | Length of Hospital Stay | 2-3 wks | Intention to treat analysis based on group assignment at randomization | days | MEDIAN |
| SECONDARY | Postoperative Fontan Pressure | postoperative hour 0, 12 and 24 | Participants with available data at the respective time points are included in the analysis. | mmHg | MEDIAN |
| SECONDARY | Postoperative Atrial Pressure | postoperative hour 0, 12 and 24 | Participants with available data at the respective time points are included in the analysis. | mmHg | MEDIAN |
| SECONDARY | Postoperative Transpulmonary Gradient | postoperative hour 0, 12 and 24 | Participants with available data at the respective time points are included in the analysis. | mmHg | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Chest Tube Duration | Treprostinil | 8.0 | Inter-Quartile Range 7.0 to 12.5 | days | |
| Chest Tube Duration | Saline | 7.0 | Inter-Quartile Range 5.0 to 8.0 | days | |
| Length of Hospital Stay | Treprostinil | 11.0 | Inter-Quartile Range 9.5 to 14.5 | days | |
| Length of Hospital Stay | Saline | 9.0 | Inter-Quartile Range 8.0 to 10.0 | days | |
| Postoperative Fontan Pressure | Treprostinil | Fontan pressure- postoperative hour 0 | 13.0 | Inter-Quartile Range 11.0 to 15.0 | mmHg |
| Postoperative Fontan Pressure | Saline | Fontan pressure- postoperative hour 0 | 12.5 | Inter-Quartile Range 11.0 to 13.25 | mmHg |
| Postoperative Fontan Pressure | Treprostinil | Fontan pressure- postoperative hour 12 | 13.0 | Inter-Quartile Range 12.25 to 15.0 | mmHg |
| Postoperative Fontan Pressure | Saline | Fontan pressure- postoperative hour 12 | 10.5 | Inter-Quartile Range 8.0 to 12.75 | mmHg |
| Postoperative Fontan Pressure | Treprostinil | Fontan pressure- postoperative hour 24 | 13.0 | Inter-Quartile Range 11.5 to 15.5 | mmHg |
| Postoperative Fontan Pressure | Saline | Fontan pressure- postoperative hour 24 | 9.0 | Inter-Quartile Range 8.0 to 15.5 | mmHg |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treprostinil | 16 | |
| Overall Study | STARTED | Saline | 18 | |
| Overall Study | COMPLETED | Treprostinil | 12 | |
| Overall Study | COMPLETED | Saline | 18 | |
| Overall Study | NOT COMPLETED | Treprostinil | 4 | |
| Overall Study | NOT COMPLETED | Saline | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Site pain | General disorders | Treprostinil | 7 | 16 | |
| other | Site pain | General disorders | Saline | 0 | 18 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treprostinil | 0 | 16 |
| Total, all-cause mortality | Saline | 0 | 18 |
| Total, other adverse events | Treprostinil | 7 | 16 |
| Total, other adverse events | Saline | 0 | 18 |
| Total, serious adverse events | Treprostinil | 0 | 16 |
| Total, serious adverse events | Saline | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29126699 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treprostinil vs Saline: deaths from any cause | Trial comparisons |
| Treprostinil vs Saline: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02498444
GET https://conductscience.org/api/trials/v1/NCT02498444/results?page=2