Tranexamic Acid in Pediatric Scoliosis Surgery

NCT ID: NCT06091891

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2025-09-01

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.

Detailed Description

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Conditions

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Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

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

ROTEM-guided

Group Type EXPERIMENTAL

Tranexamic acid infusion under ROTEM-guidance

Intervention Type DRUG

If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.

Interventions

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Tranexamic acid

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

Intervention Type 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.

Intervention Type DRUG

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun-hee Kim

clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Bin Park

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

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Seoul national university hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Bin Park

Role: CONTACT

820220723664

Facility Contacts

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Eun-hee Kim

Role: primary

820220723664 ext. 82

Other Identifiers

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2308-113-1459

Identifier Type: -

Identifier Source: org_study_id

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