Tranexamic Acid in Pediatric Scoliosis Surgery

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06091891

Collaborator

(none)

Enrollment

Location

Arms

22.5

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scoliosis	Drug: Tranexamic acid Drug: Tranexamic acid infusion under ROTEM-guidance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Oct 16, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
urine output [during surgery (From induction of anesthesia to when the patient leaves the operating room.)]
intraoperative total urine output during surgery per hour
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.
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
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
postoperative complications [2 weeks from the end of surgery]
Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul national university hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eun-hee Kim, clinical associate professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT06091891

Other Study ID Numbers:

2308-113-1459

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Scoliosis

Tranexamic Acid

Study Results

No Results Posted as of Oct 19, 2023