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Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass (TRICC-2)

Primary Purpose

Congenital Heart Defects

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Triostat
Placebo
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects

Eligibility Criteria

undefined - 5 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent obtained
  2. Male and female patients <5 months (152 days) of age
  3. Patients undergoing cardiopulmonary bypass

Exclusion Criteria:

  1. Known thyroid disease (Down Syndrome is not an exclusion criterion unless patient has thyroid disease)
  2. Trisomy 13 and 18
  3. Prolonged preoperative ventilator support which would not be impacted by cardiac surgery (Lung disease: bronchopulmonary dysplasia, hypoplastic lungs associated with diaphragmatic hernia)
  4. Any other condition as determined by the PI causing prolonged ventilator support which is unlikely to respond favorably to cardiac surgery
  5. Prior participation in the clinical trial

Sites / Locations

  • Los Angeles Children's HospitalRecruiting
  • Lucille Packard Children's HospitalRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Triostat

Placebo

Arm Description

Active Medication - Synthetic Thyroid Hormone

Placebo Control

Outcomes

Primary Outcome Measures

Time To Extubation

Secondary Outcome Measures

ICU Length of Stay
Length of stay in the ICU
Discharge on Oral Feeds
Whether or not patient is discharged on oral feeding
Mortality
Mortality (if applicable)
Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable
start of ECMO (if applicable) meets this secondary endpoint, indicates significant patient regression for inpatient status post-operatively.

Full Information

First Posted
December 5, 2014
Last Updated
July 18, 2018
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02320669
Brief Title
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Acronym
TRICC-2
Official Title
Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triostat
Arm Type
Experimental
Arm Description
Active Medication - Synthetic Thyroid Hormone
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Control
Intervention Type
Drug
Intervention Name(s)
Triostat
Other Intervention Name(s)
triiodothyronine
Intervention Description
Bolus of Triiodothyronine followed by infusion for 48 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Bolus of Placebo followed by infusion for 48 hours
Primary Outcome Measure Information:
Title
Time To Extubation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
ICU Length of Stay
Description
Length of stay in the ICU
Time Frame
30 days
Title
Discharge on Oral Feeds
Description
Whether or not patient is discharged on oral feeding
Time Frame
30 days
Title
Mortality
Description
Mortality (if applicable)
Time Frame
30 days
Title
Duration of freedom from Extracorporeal Membrane Oxygenation (ECMO) - if applicable
Description
start of ECMO (if applicable) meets this secondary endpoint, indicates significant patient regression for inpatient status post-operatively.
Time Frame
30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained Male and female patients <5 months (152 days) of age Patients undergoing cardiopulmonary bypass Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Portman, MD
Phone
206-987-1014
Email
michael.portman@seattlechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Cox, MASc
Phone
206-884-5153
Email
Jennifer.Cox@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Portman, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Children's Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Hastings, MD
Email
LHastings@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Laura Hastings, MD
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Roth, MD
Phone
650-725-8349
Email
sroth@stanford.edu
First Name & Middle Initial & Last Name & Degree
Aihua Zhu, CCRP
Phone
650-384-5917
First Name & Middle Initial & Last Name & Degree
Stephen Roth, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer A Cox, MASc
Phone
206-884-5153
Email
Jennifer.Cox@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Michael A Portman, MD
Phone
206-987-1014
Email
michael.portman@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Michael Portman, MD

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

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