RecruitingNot ApplicableNCT05874843

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


Sponsor

Indiana University

Enrollment

125 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 3 MonthsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study validates point-of-care thromboelastography (TEG 6s) — a bedside blood clotting test — in pediatric patients undergoing elective surgery. TEG 6s rapidly measures how well blood clots by analyzing the full coagulation process in real time. While it is widely used in adults, its accuracy and reliability in children have not been as thoroughly validated. Better, faster understanding of a child's clotting ability during surgery could help surgical teams make smarter, safer decisions about blood products and medications. Children under 18 years of age who are scheduled for elective surgery at Riley Hospital for Children are eligible. Children with known bleeding disorders, those taking medications that affect clotting, and children in foster care or who are wards of the court are excluded from the study. Blood samples will be collected during routine pre-operative blood draws, and TEG 6s results will be compared to standard laboratory coagulation tests. This research is significant because validating a point-of-care clotting test in children could improve surgical safety and blood management, reducing both the risks of dangerous bleeding and unnecessary blood transfusions in pediatric patients.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTThromboelastography (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.


Locations(1)

Riley Hospital for Children

Indianapolis, Indiana, United States

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NCT05874843


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