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

Conditions

• Coagulopathy

Eligibility Criteria

Sex

ALL

Age

3 Months - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Thromboelastography (TEG 6S) — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Sep 11, 2023

Status verified

May 2025

Primary completion

Aug 1, 2026

Completion

Dec 1, 2026

Study Design

Enrollment

125 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

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.

Primary Outcome Measure

TEG 6s viscoelastic measurement, angle, in pediatric surgical patients [ Time Frame: 2 months ]

Central Contacts

• Matthew Landman, MD, MPH
  317-944-4681
  [email protected]

Locations (1)

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