Validation of TEG 6s in Pediatric Patients

This study is looking at how well a diagnostic test called Thromboelastography (TEG 6s) works in children who are having surgery. TEG 6s is a test that uses a small amount of blood to check how well blood clots. Researchers want to find out what normal TEG 6s results look like in children and compare them to existing information. You might be able to join if you are between 3 months and 18 years old and are having an elective surgery at Riley Hospital for Children. You cannot join if you have a known bleeding disorder or take medications that affect blood clotting. The study will look at specific measurements from the TEG 6s test, like the angle, R time, and maximum amplitude, over two months to see if the test is accurate.

Study design
This is an interventional study with a planned enrollment of 125 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will be asked to provide a small amount of blood at the beginning of their elective surgery for analysis using the TEG 6s machine.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at 2 months after the initial test.

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NCT05874843

Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients

Recruiting
NAAges 3–18InterventionalDiagnostic
Indiana University
~125 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Thromboelastography (TEG 6S)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
TEG 6s viscoelastic measurement, angle, in pediatric surgical patients
Measured over Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection
+3 more outcomes measured
Coagulopathy
1 sites across 1 states
Indiana1

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Eligibility criteria

Inclusion

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

Exclusion

Known disorder of coagulation pathway(s)
Administration of medications that may alter the coagulation cascade
Patients in foster care or wards of the court
  • TEG 6s viscoelastic measurement, angle, in pediatric surgical patientsDay 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection

    To validate the TEG 6S measurement values in pediatric patients by comparing its viscoelastic values with those existing published reference ranges

  • TEG 6s viscoelastic measurements, R time, in pediatric surgical patientsDay 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection

    To validate the TEG 6S measurement values in pediatric patients by comparing its viscoelastic values with those existing published reference ranges

  • TEG 6s viscoelastic measurement, maximum amplitude, in pediatric surgical patientsDay 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection

    To validate the TEG 6S measurement values in pediatric patients by comparing its viscoelastic values with those existing published reference ranges

  • TEG 6s viscoelastic measurement, lysis at 30 minutes, in pediatric surgical patientsDay 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection

    To validate the TEG 6S measurement values in pediatric patients by comparing its viscoelastic values with those existing published reference ranges