Tranexamic Acid in Pediatric Scoliosis Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Tranexamic acid infusion under ROTEM-guidance

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Bin Park; Phone Number: 820220723664; Email: jb4001@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Eun-hee Kim; Phone Number: 82 820220723664; Email: beloveun@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Drug: Tranexamic acid; Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
Experimental: ROTEM-guided	Drug: Tranexamic acid infusion under ROTEM-guidance; If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative bleeding loss	total volume of blood loss during surgery determined by anesthesiologist	during surgery (From induction of anesthesia to when the patient leaves the operating room.)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RBC blood transfusion	intraoperative red blood cell volume of transfused during surgery per hour	during surgery (From induction of anesthesia to when the patient leaves the operating room.)
urine output	intraoperative total urine output during surgery per hour	during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Other blood transfusion	Volume of blood cells transfused during surgery per hour, such as FFP, platelets, and cryoprecipitates.	during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative viscoelastic whole blood profile	CT, CFT, A10, MCF, ML in EXTEM and CT, CFT, A10, MCF, ML in FIBTEM at the end of surgery	1 hours from the end of surgery
JP drain	total JP drain for 24 hours after the end of surgery	24 hours from the end of surgery
IL-6	the change in IL-6 values before and after surgery	1 hours from the end of surgery
total tranexamic acid dose	Total amount of tranexamic acid used during surgery	during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative complications	Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.	2 weeks from the end of surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Director: Jung-Bin Park, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2308-113-1459

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No