Tranexamic Acid in Pediatric Scoliosis Surgery

Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091891
• Other study ID #: 2308-113-1459
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2023
• Source: Seoul National University Hospital
• Contact: Jung-Bin Park
• Phone: 820220723664
• Email: jb4001[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Intervention

Drug:
• Tranexamic acid
Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.)
Secondary	urine output	intraoperative total urine output during surgery per hour	during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Secondary	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.)
Secondary	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
Secondary	JP drain	total JP drain for 24 hours after the end of surgery	24 hours from the end of surgery
Secondary	IL-6	the change in IL-6 values before and after surgery	1 hours from the end of surgery
Secondary	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.)
Secondary	postoperative complications	Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.	2 weeks from the end of surgery