Clinical Trials Directory

Trials / Unknown

UnknownNCT06091891

Tranexamic Acid in Pediatric Scoliosis Surgery

Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
84 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
1 Year – 18 Years
Healthy volunteers
Accepted

Summary

This study aims to investigate whether intraoperative administration of tranexamic acid based on ROTEM® (Rotational Thromboelastometry), in pediatric patients undergoing scoliosis surgery, results in a difference in intraoperative blood loss when compared to the prophylactic administration of tranexamic acid.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic acidWithout ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
DRUGTranexamic acid infusion under ROTEM-guidanceIf diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.

Timeline

Start date
2023-10-16
Primary completion
2025-08-01
Completion
2025-09-01
First posted
2023-10-19
Last updated
2023-10-19

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06091891. Inclusion in this directory is not an endorsement.