Tranexamic Acid in Pediatric Scoliosis Surgery
Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedOctober 19, 2023
October 1, 2023
1.8 years
October 13, 2023
October 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
RBC blood transfusion
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
urine output
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Other blood transfusion
during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative viscoelastic whole blood profile
1 hours from the end of surgery
JP drain
24 hours from the end of surgery
- +3 more secondary outcomes
Study Arms (2)
Control
ACTIVE COMPARATORROTEM-guided
EXPERIMENTALInterventions
Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.
Eligibility Criteria
You may qualify if:
- Children undergoing scoliosis surgery under the age of 18
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jung-Bin Park
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical associate professor
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 19, 2023
Study Start
October 16, 2023
Primary Completion
August 1, 2025
Study Completion
September 1, 2025
Last Updated
October 19, 2023
Record last verified: 2023-10