Actively Recruiting
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
Led by Indiana University · Updated on 2025-10-31
125
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how the TEG 6s machine performs in normal pediatric patients by comparing its lab results to existing reference ranges. Trauma is a leading cause of death in children, with early mortality often linked to bleeding issues that affect clotting. Traditional coagulation tests take time and may delay treatment, so new methods like TEG 6s are being studied to provide faster, more useful information for managing bleeding in children. The study involves pediatric surgery patients undergoing elective operations, where a small blood sample will be taken at the start of surgery for analysis using the TEG 6s device. This device uses a microfluidic cartridge to assess blood clotting dynamics quickly and with less user error than older machines. The results from this test will not influence clinical decisions during the surgery. Participants and their guardians will provide blood samples for testing, and researchers will measure clotting factors such as angle, R time, maximum amplitude, and lysis at 30 minutes within two months. The study focuses on collecting data to validate the TEG 6s in children, and participants will not receive additional treatments as part of this study. The trial is expected to end in late 2026.
CONDITIONS
Brief Title
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients less than 18 years of age undergoing elective pediatric surgical care in the operating room at Riley Hospital for Children
You will not qualify if you...
- Known disorder of coagulation pathway(s)
- Administration of medications that may alter the coagulation cascade
- Patients in foster care or wards of the court
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day during surgery
Participants undergo thromboelastography (TEG 6s) testing with a small blood sample during elective pediatric surgical procedures to evaluate clot dynamics.
1 visit during surgery (in-person)
Duration - 2 months
Participants are observed for up to 2 months following the surgical procedure to assess the TEG 6s measurements over time.
Follow-up visits as scheduled for measurement collection
Trial Site Locations
Total: 1 location
1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Matthew Landman, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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