Using tranexamic acid to reduce blood loss in children during scoliosis surgery
Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
NA · Seoul National University Hospital · NCT06091891
This study is testing if giving tranexamic acid during scoliosis surgery can help reduce blood loss in children compared to the usual method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06091891 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of administering tranexamic acid during scoliosis surgery in pediatric patients, specifically comparing the outcomes of intraoperative blood loss when using ROTEM® guidance versus standard prophylactic administration. The goal is to determine if this tailored approach can lead to improved blood management during surgery. The study involves children under 18 years old who are scheduled for scoliosis surgery, with careful monitoring of their coagulation status. The findings could provide insights into optimizing surgical outcomes for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old who are scheduled for scoliosis surgery.
Not a fit: Patients with coagulation disorders, increased risk of thrombosis, or a history of severe allergic reactions to tranexamic acid may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce blood loss during scoliosis surgeries in children, leading to better recovery and fewer complications.
How similar studies have performed: Other studies have shown promising results with tranexamic acid in reducing blood loss in surgical settings, suggesting that this approach may be effective in pediatric scoliosis surgery as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children undergoing scoliosis surgery under the age of 18 Exclusion Criteria: * Patients with coagulation disorders * Patients at an increased risk of thrombosis * Patients with a history of epilepsy or brain surgery * Patients with a previous allergic reaction or anaphylaxis history to tranexamic acid * Severe liver or kidney impairment * Other cases deemed inappropriate by the researcher
Where this trial is running
Seoul
- Seoul national university hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Jung-Bin Park
- Email: jb4001@snu.ac.kr
- Phone: 820220723664
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.
Conditions: Scoliosis