Tranexamic Acid in Pediatric Scoliosis Surgery

Not Applicable

Recruiting

• Conditions: Scoliosis
• Interventions: Drug: Tranexamic acid; Drug: Tranexamic acid infusion under ROTEM-guidance

• Registration Number: NCT06091891
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Last Update Submitted: 2023-10-13
• Study Start: 2023-10-16
• Study First Posted: 2023-10-19
• Last Update Posted: 2023-10-19
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Children undergoing scoliosis surgery under the age of 18

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Tranexamic acid	-
ROTEM-guided	Tranexamic acid infusion under ROTEM-guidance	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of