Scoliosis Clinical Trial
Official title:
Effect of ROTEM®-Guided Algorithm for Tranexamic Acid Administration in Pediatric Scoliosis Surgery: a Prospective Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | September 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul national university hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | RBC blood transfusion | intraoperative red blood cell volume of transfused during surgery per hour | during surgery (From induction of anesthesia to when the patient leaves the operating room.) | |
Secondary | urine output | intraoperative total urine output during surgery per hour | during surgery (From induction of anesthesia to when the patient leaves the operating room.) | |
Secondary | Other blood transfusion | Volume of blood cells transfused during surgery per hour, such as FFP, platelets, and cryoprecipitates. | during surgery (From induction of anesthesia to when the patient leaves the operating room.) | |
Secondary | 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 | 1 hours from the end of surgery | |
Secondary | JP drain | total JP drain for 24 hours after the end of surgery | 24 hours from the end of surgery | |
Secondary | IL-6 | the change in IL-6 values before and after surgery | 1 hours from the end of surgery | |
Secondary | total tranexamic acid dose | Total amount of tranexamic acid used during surgery | during surgery (From induction of anesthesia to when the patient leaves the operating room.) | |
Secondary | postoperative complications | Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events. | 2 weeks from the end of surgery |
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