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Tranexamic Acid in Pediatric Scoliosis Surgery

Primary Purpose

Scoliosis

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tranexamic acid
Tranexamic acid infusion under ROTEM-guidance
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Scoliosis

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul national university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

ROTEM-guided

Arm Description

Outcomes

Primary Outcome Measures

intraoperative bleeding loss
total volume of blood loss during surgery determined by anesthesiologist

Secondary Outcome Measures

RBC blood transfusion
intraoperative red blood cell volume of transfused during surgery per hour
urine output
intraoperative total urine output during surgery per hour
Other blood transfusion
Volume of blood cells transfused during surgery per hour, such as FFP, platelets, and cryoprecipitates.
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
JP drain
total JP drain for 24 hours after the end of surgery
IL-6
the change in IL-6 values before and after surgery
total tranexamic acid dose
Total amount of tranexamic acid used during surgery
postoperative complications
Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.

Full Information

First Posted
October 13, 2023
Last Updated
October 13, 2023
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06091891
Brief Title
Tranexamic Acid in Pediatric Scoliosis Surgery
Official Title
Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Anticipated)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
ROTEM-guided
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Intervention Description
Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid infusion under ROTEM-guidance
Intervention Description
If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.
Primary Outcome Measure Information:
Title
intraoperative bleeding loss
Description
total volume of blood loss during surgery determined by anesthesiologist
Time Frame
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Secondary Outcome Measure Information:
Title
RBC blood transfusion
Description
intraoperative red blood cell volume of transfused during surgery per hour
Time Frame
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Title
urine output
Description
intraoperative total urine output during surgery per hour
Time Frame
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Title
Other blood transfusion
Description
Volume of blood cells transfused during surgery per hour, such as FFP, platelets, and cryoprecipitates.
Time Frame
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Title
postoperative viscoelastic whole blood profile
Description
CT, CFT, A10, MCF, ML in EXTEM and CT, CFT, A10, MCF, ML in FIBTEM at the end of surgery
Time Frame
1 hours from the end of surgery
Title
JP drain
Description
total JP drain for 24 hours after the end of surgery
Time Frame
24 hours from the end of surgery
Title
IL-6
Description
the change in IL-6 values before and after surgery
Time Frame
1 hours from the end of surgery
Title
total tranexamic acid dose
Description
Total amount of tranexamic acid used during surgery
Time Frame
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Title
postoperative complications
Description
Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.
Time Frame
2 weeks from the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Bin Park
Phone
820220723664
Email
jb4001@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Bin Park
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-hee Kim
Phone
820220723664
Ext
82
Email
beloveun@snu.ac.kr

12. IPD Sharing Statement

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Tranexamic Acid in Pediatric Scoliosis Surgery

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