TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss (NCT05379530) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss
60 participantsStarted 2025-01-01
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pediatric patients undergoing non-cardiac surgery at BCH with a high likelihood of blood transfusion. Specifically these are defined as a surgery with greater than 25% likelihood of transfusion of any non-albumin blood product.
* Eligible surgeries include:
* spinal surgery
* laparotomy
* liver transplant
* craniofacial surgery
* esophageal atresia
* craniotomy/hemispherectomy
* major abdominal surgery
* major hip surgery
* major plastic surgery
Exclusion Criteria:
* Patients undergoing cardiac surgery or ECMO cannulation, as these surgeries are generally considered outside the scope of general pediatric surgery.
* Patients presenting for emergent surgery
* Patients undergoing surgeries off hours (between 8pm and 8 am), when TEG analysis is unobtainable
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of utilizing Viscoelastic testing (Thromboelastography;TEG) to diagnose and guide management as measured by type of hemostatic blood products transfused.
Timeframe: 1 year
2
Efficacy of utilizing Viscoelastic testing (TEG) to diagnose and guide intraoperative management as measured by amount (mL/kg) hemostatic blood products transfused.