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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| ROTEM-guided | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Without ROTEM-guidance, we maintain tranexamic acid infusion at 10mg/kg/h until the end of the surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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.) |
| urine output |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-Bin Park | Contact | 820220723664 | jb4001@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jung-Bin Park | Seoul National University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Tranexamic acid infusion under ROTEM-guidance | Drug | If diffuse bleeding occurs during surgery, we perform ROTEM testing and administer tranexamic acid based on the test results. |
|
intraoperative total urine output during surgery per hour
| 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. | 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 | 1 hours from the end of surgery |
| JP drain | total JP drain for 24 hours after the end of surgery | 24 hours from the end of surgery |
| IL-6 | the change in IL-6 values before and after surgery | 1 hours from the end of surgery |
| 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.) |
| postoperative complications | Presence of unexpected ICU admissions, mechanical ventilation, respiratory complications, convulsions, and thromboembolic events. | 2 weeks from the end of surgery |