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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
84
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.
Seoul national university hospital
Seoul, South Korea
RECRUITINGintraoperative bleeding loss
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.)
RBC blood transfusion
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.)
urine output
intraoperative total urine output during surgery per hour
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
Other blood transfusion
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.)
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
Time frame: 1 hours from the end of surgery
JP drain
total JP drain for 24 hours after the end of surgery
Time frame: 24 hours from the end of surgery
IL-6
the change in IL-6 values before and after surgery
Time frame: 1 hours from the end of surgery
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total tranexamic acid dose
Total amount of tranexamic acid used during surgery
Time frame: during surgery (From induction of anesthesia to when the patient leaves the operating room.)
postoperative complications
Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events.
Time frame: 2 weeks from the end of surgery