Health TrialsbyHealthPanel

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

ConditionCoagulopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorIndiana University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Known disorder of coagulation pathway(s)

Administration of medications that may alter the coagulation cascade

Patients in foster care or wards of the court

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

125 Participants
are divided into 1 treatment group
Group A: Pediatric ParticipantsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection
2

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

Time frame
Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection
3

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

Time frame
Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection
4

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

Time frame
Day 1, sample drawn at the time of clinical IV placement and evaluated within 1-4 hours of collection

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Source ClinicalTrials.gov
Apply now