Tranexamic Acid in Pediatric Scoliosis Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Scoliosis

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Tranexamic acid infusion under ROTEM-guidance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |