Congenital Heart DefectsPhase 3TRICC-2NCT02320669
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
A Phase 3 study testing Triostat in people with Congenital Heart Defects, run by Seattle Children's Hospital at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 months
- Conditions the study is for
- Congenital Heart Defects
- What is being tested?
- Triostat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2014to Oct 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Informed consent obtained
- Male and female patients <5 months (152 days) of age
- Patients undergoing cardiopulmonary bypass
Who cannot join
- Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
- Trisomy 13 and 18
- Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
- Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
- Prior participation in the clinical trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Los Angeles Children's Hospital
Los Angeles, California, 90027
Lucille Packard Children's Hospital
Palo Alto, California, 94304
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
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.
- Conditions
- Congenital Heart Defects
- Being tested
- Triostat, Placebo
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriostatDrug
Also called triiodothyronine
Bolus of Triiodothyronine followed by infusion for 48 hours
PlaceboDrug
Bolus of Placebo followed by infusion for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Triostat | Experimental | Active Medication - Synthetic Thyroid Hormone Receives: Drug: Triostat |
| Placebo | Placebo comparator | Placebo Control Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Extubation
time on mechanical ventilation after aortic cross clamp removal
Measured: 30 days
Secondary outcomes (1)
ICU Length of Stay
Length of stay in the ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Portman, Seattle Children's Hospital
- Investigators
- Michael Portman, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320669
- Sponsor's protocol ID
- 14798
- Other IDs
- R01FD004362-01A2
- Acronym
- TRICC-2
- Status last verified
- Mar 2024
- First submitted
- 5 Dec 2014
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Surg. 2023 Spring;35(1):105-112. doi: 10.1053/j.semtcvs.2022.01.005. Epub 2022 Jan 31.
PubMed 35093535
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02320669
- Acronym / sponsor ID
- TRICC-2 / 14798
- Conditions
- Congenital Heart Defects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triostat | Experimental | Drug: TriostatActive Medication - Synthetic Thyroid Hormone |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Control |
Who may qualify
- Ages
- Up to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Informed consent obtained
- Male and female patients <5 months (152 days) of age
- Patients undergoing cardiopulmonary bypass
Key exclusion criteria (5 listed)
- Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
- Trisomy 13 and 18
- Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
- Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
- Prior participation in the clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TriostatAlso: triiodothyronineBolus of Triiodothyronine followed by infusion for 48 hours | Drug | Triostat |
| PlaceboBolus of Placebo followed by infusion for 48 hours | Drug | Placebo |
Primary outcome
Time To Extubation
Time frame: 30 days
time on mechanical ventilation after aortic cross clamp removal
1 secondary outcome
ICU Length of Stay
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35093535Portman MA, Slee AE, Roth SJ, Radman M, Olson AK, Mainwaring RD, Kamerkar A, Nuri M, Hastings L; TRICC Investigators. Triiodothyronine Supplementation in Infants Undergoing Cardiopulmonary Bypass: A Randomized Controlled Trial. Semin Thorac Cardiovasc Surg. 2023 Spring;35(1):105-112. doi: 10.1053/j.semtcvs.2022.01.005. Epub 2022 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Portman, MD principal investigator
Seattle Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triostat in people with Congenital Heart Defects, run by Seattle Children's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Extubation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.