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Trial · NCT03661385

Nitric Oxide During Bypass for Arterial Switch Operation

NCT03661385, Phase 3, Completed, Murdoch Childrens Research Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Nitric Oxide During Bypass for Arterial Switch Operation. Trials, record NCT03661385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03661385

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Nitric Oxide During Bypass for Arterial Switch Operation
NCT number
NCT03661385
Status
Completed
Phases
Phase 3
Enrollment
300 participants, actual
Lead sponsor
Murdoch Childrens Research Institute
Conditions
Low Cardiac Output Syndrome, Transposition of Great Vessels
Interventions
Nitric Oxide
First posted
2018-09-07
Last updated
2024-04-18

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMajor adverse events28 days post interventionThe primary outcome is the number of participants with major adverse events (MAEs) within 28 days post-operatively. MAEs include cardiac arrest, emergency chest opening, use of ECMO, and death.
SecondaryLength of stay in ICU (hours)This will be calculated from date and time of admission to ICU to date and time of discharge from ICU in hours up to 28 daysLength of stay in ICU (hours) will be calculated from date and time of admission to ICU date and time of discharge to ICU.
SecondaryLength of stay in hospital (days)28 days (or until hospital discharge)Length of stay in hospital (days) will be calculated from date and time of admission to hospital to date and time of discharge to hospital.
SecondaryVentilator-free days28 days (or until ICU discharge)Ventilator-free days will be calculated from date and time of intubation to date and time of extubation. Each day (or part of a day) will be counted as a day.
SecondaryInotrope hoursNumber of hours inotropes have been administered during first 28 days post operativelyInotrope hours will be calculated from data input into REDCAP.
SecondaryDialysis-free days28 days (or until ICU discharge)Dialysis-free days will be calculated from date and time of start of dialysis to date and time of stopping dialysis. Each day (or part of a day) will be counted as a day.
SecondaryInhaled NO hoursNumber of hours inhaled NO have been administered during first 28 days post operativelyInhaled NO hours will be calculated from data input into REDCAP.
SecondaryECMO-free days28 days (or until ICU discharge)ECMO-free days will be calculated from date and time of start of ECMO to date and time of stopping ECMO. Each day (or part of a day) will be counted as a day.
SecondaryClosed sternum days28 days (or until ICU discharge)
Closed sternum days will be calculated from date and time of start of chest opening (or return to ICU time if delayed chest closure) to date and time of chest closure. Each day (or part of a day) will be counted as a day.
SecondaryComposite free-day score28 days (or until hospital discharge)
This score is a combination of scores 1-8 to create a composite free-day score. Composite free-day score is a score highlighting the number of days free from post-operative complications including free of hospitalization within the first 28 days post operatively. For each score, the days free of complication will be calculated to create an individual free from score these will be then added together to create an overall free-from score. Higher scores suggest a better outcome (free from hospital and complications).

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
9525554BACKGROUNDPubMed
10435044BACKGROUNDPubMed
12607717BACKGROUNDPubMed
16443673BACKGROUNDPubMed
23228403RESULTPubMed
27686343RESULTPubMed

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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT03661385

GET https://conductscience.org/api/trials/v1/NCT03661385/registered