NCT05874843

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Sep 2023Dec 2026

First Submitted

Initial submission to the registry

April 25, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

April 25, 2023

Last Update Submit

October 30, 2025

Conditions

Coagulopathy

Keywords

thromboelastography

Outcome Measures

Primary Outcomes (4)

  • TEG 6s viscoelastic measurement, angle, in pediatric surgical patients

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

    2 months

  • TEG 6s viscoelastic measurements, R time, in pediatric surgical patients

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

    2 months

  • TEG 6s viscoelastic measurement, maximum amplitude, in pediatric surgical patients

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

    2 months

  • TEG 6s viscoelastic measurement, lysis at 30 minutes, in pediatric surgical patients

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

    2 months

Study Arms (1)

Pediatric Participants

OTHER

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.

Diagnostic Test: Thromboelastography (TEG 6S)

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.

Pediatric Participants

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Matthew Landman, MD, MPH

CONTACT

317-944-4681landman@iu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

April 25, 2023

First Posted

May 25, 2023

Study Start

September 11, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 31, 2025

Record last verified: 2025-05

Locations

US(1)