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| ID | Type | Description | Link |
|---|---|---|---|
| R01FD004362-01A2 | U.S. FDA Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triostat | Experimental | Active Medication - Synthetic Thyroid Hormone |
|
| Placebo | Placebo Comparator | Placebo Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triostat | Drug | Bolus of Triiodothyronine followed by infusion for 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time To Extubation | time on mechanical ventilation after aortic cross clamp removal | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Length of Stay | Length of stay in the ICU | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Portman, MD | Seattle Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Children's Hospital | Los Angeles | California | 90027 | United States | ||
| Lucille Packard Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35093535 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triiodothyronine | Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours |
| FG001 | Placebo | Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triostat | Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours |
| BG001 | Placebo | Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time To Extubation | time on mechanical ventilation after aortic cross clamp removal | modified intention to treat | Posted | Median | 95% Confidence Interval | hours | 30 days |
|
30 days after receiving study medication
Definitions were adopted from Pediatric Heart Network criteria
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triostat | Active Medication - Synthetic Thyroid Hormone Triostat: Bolus of Triiodothyronine followed by infusion for 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sentinel | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Sentinel including cardiac arrest and ECMO |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Postoperative arrhythmia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael A Portman | Seattle Childrens hospital | 206-987-1014 | michael.portman@seattlechildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2015 | Feb 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D014284 | Triiodothyronine |
| ID | Term |
|---|---|
| D013970 | Thyronines |
| D013963 | Thyroid Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug | Bolus of Placebo followed by infusion for 48 hours |
|
| Palo Alto |
| California |
| 94304 |
| United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| Secondary | ICU Length of Stay | Length of stay in the ICU | Children under age 5 mos undergoing cardiopulmonary bypass | Posted | Median | 95% Confidence Interval | days | 30 days |
|
|
|
| 6 |
| 110 |
| 11 |
| 110 |
| 17 |
| 110 |
| EG001 | Placebo | Placebo Control Placebo: Bolus of Placebo followed by infusion for 48 hours | 3 | 110 | 11 | 110 | 20 | 110 |
|
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013974 | Thyroxine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |