Clinical Trial

TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss

Not Yet Recruiting
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Summary
The research team proposes a prospective, observational study to better understand how TEG can be useful in guiding clinical practice in the Main OR for subject's undergoing high transfusion risk surgeries. Intraoperatively, transfusion of blood products is frequently required to restore oxygen carrying capacity, perfusion and improve coagulation. Both under and over transfusion pose significant risks, particularly to pediatric patients with small starting intravascular volumes. Thromboelastography (TEG) is a validated method of dynamically assessing intraoperative coagulopathy via functional assay. However, while FDA approved and widely used in the adult setting, TEG is not commonly utilized in the setting of bleeding pediatric patients. Recently, TEG has been made available at BCH for clinical purposes and is being used solely in the cardiac surgery setting. The investigators aim to provide TEG data for non-cardiac pediatric surgical cases with a high risk of intraoperative blood loss in order to assess the impact of this tool on intraoperative management.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2025-12-01 -> 2028-12-01 2026-08-15
minor Completion pushed: 2025-12-01 -> 2028-12-01 2026-08-15
Trial Details
NCT Number NCT05379530
Lead Sponsor Boston Children's Hospital
Conditions Surgical Blood Loss, Surgical Hemorrhage, Post Operative Hemorrhage
Enrollment 60 participants
Start Date 2027-01-01
Primary Completion 2028-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-14