At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
Triostat +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
In Brief
A Phase 3 clinical trial evaluating Triostat and Placebo for Congenital Heart Defects. Completed, enrolled 220 participants across 3 sites.
Detailed Summary
This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Heart Defects
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedDec 2014
Primary CompletionOct 2019
TodayJul 2026
First PostedDec 19, 2014
Enrollment StartNov 1, 2014
Primary CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 11.5 years ago
Interventions
Triostatdrug
Bolus of Triiodothyronine followed by infusion for 48 hours
Placebodrug
Bolus of Placebo followed by infusion for 48 hours