Scoliosis
Conditions
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.
Interventions
DRUGTranexamic acid
Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery.
DRUGTranexamic acid infusion under ROTEM-guidance
If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| JP drain | 24 hours from the end of surgery | total JP drain for 24 hours after the end of surgery |
Countries
South Korea
Contacts
Primary ContactJung-Bin Park
Outcome results
None listed