Recruiting

Observational Study

Sponsor:

Indiana University

Code:

NCT05874843

Conditions

Coagulopathy

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Thromboelastography (TEG 6S)

Study Details

Brief summary:

The goal of this observational study is to learn about the performance of the TEG6s in normal pediatric patients. The main questions it aims to answer are: What are the normal TEG 6S lab results in normal pediatric patients and how do they compare to existing published reference ranges. Participants and their guardians will be asked to submit a small amount of blood at the beginning of an elective operation for analysis in the TEG 6s machine.

Conditions

Coagulopathy

Study ID

NCT05874843

Start date

Sep 11, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Patients less than 18 years of age undergoing elective pediatric surgical care in the operating room at Riley Hospital for Children

Exclusion Criteria:

  • Known disorder of coagulation pathway(s)
  • Administration of medications that may alter the coagulation cascade
  • Patients in foster care or wards of the court

Study Design

Enrollment

125 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Pediatric Participants

Pediatric surgery patients undergoing elective pediatric surgical cases under anesthesia will be invited to participate in this prospective laboratory test validation study. The results of the interventional test will not be used in clinical decision making for the participant.

Interventions

Thromboelastography (TEG 6S)

The TEG 6s assays are performed in a microfluidic cartridge which only requires a small amount of a patient's blood be transferred to the cartridge for analysis. The vibration frequency of the blood meniscus at which resonance occurs is used to create a clot dynamics tracing.

Primary outcome measure

  • TEG 6s viscoelastic measurement, angle, in pediatric surgical patients [ Time Frame: Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection ]
  • TEG 6s viscoelastic measurements, R time, in pediatric surgical patients [ Time Frame: Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection ]
  • TEG 6s viscoelastic measurement, maximum amplitude, in pediatric surgical patients [ Time Frame: Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection ]
  • TEG 6s viscoelastic measurement, lysis at 30 minutes, in pediatric surgical patients [ Time Frame: Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection ]

Central Contacts and Locations

Central contacts

Matthew Landman, MD, MPH

317-944-4681landman@iu.edu

Locations

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Matthew Landman, MD

317-944-4681landman@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Keywords

  • thromboelastography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-04.