Tranexamic Acid in Pediatric Scoliosis Surgery

Seoul National University

Status: Enrolling

Conditions: Scoliosis

Treatments: Drug: Tranexamic acid infusion under ROTEM-guidance; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06091891

2308-113-1459

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Control

Active Comparator group

Treatment:

Drug: Tranexamic acid

ROTEM-guided

Experimental group

Treatment:

Drug: Tranexamic acid infusion under ROTEM-guidance