Evaluating a blood test for children undergoing surgery
Validation of Point-of-care Thromboelastography (TEG 6s) in Pediatric Patients
This study is testing a blood test for children having surgery to see if it can help doctors understand and manage bleeding better during operations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05874843 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the performance of the TEG 6s device in pediatric patients by analyzing blood samples taken during elective surgeries. The primary focus is to establish normal reference ranges for TEG 6s results in children and compare these findings with existing literature. By utilizing this point-of-care technology, the study seeks to enhance the understanding of coagulopathy in pediatric trauma cases, which is critical for timely intervention. The results could potentially lead to improved management of bleeding in children during surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who are scheduled for elective surgical procedures at Riley Hospital for Children.
Not a fit: Patients with known coagulation disorders or those receiving medications that affect coagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a rapid and accurate assessment of coagulation status in pediatric patients, leading to better management of bleeding during surgeries.
How similar studies have performed: Previous studies in adult trauma patients have shown success with similar approaches using thromboelastography, indicating potential for positive outcomes in pediatric applications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Patients less than 18 years of age undergoing elective pediatric surgical care in the operating room at Riley Hospital for Children Exclusion Criteria: * Known disorder of coagulation pathway(s) * Administration of medications that may alter the coagulation cascade * Patients in foster care or wards of the court
Where this trial is running
Indianapolis, Indiana
- Riley Hospital for Children — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Study coordinator: Matthew Landman, MD, MPH
- Email: landman@iu.edu
- Phone: 317-944-4681
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.