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Massive bleeding is expected when performing distraction osteotomy for craniosynostosis patients. Since such operation is performed at very young age, many efforts are performed in order to reduce the total amount of bleeding and the transfusion during and after the surgery. Our study aims at correcting the coagulopathy from massive bleeding and transfusion during distraction osteotomy using continuous infusion of antifibrinolytic agent, tranexamic acid. Tranexamic acid infusion is determined according to the pharmacokinetic model, and the changes in coagulopathy will be defined using thromboelastography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator |
| |
| Tranexamic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 10mg/kg of tranexamic acid loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding loss | Assessing the amount of bleeding during each intraop hours, and postoperative periods. | from every each hour during intraop, periodImmediate postop, postoperative 24hr to postoperative 48hr |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine | Seoul | Seoul | 120-752 | South Korea |
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| normal saline | Drug | 10mg/kg of normal saline loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr |
|
| ID | Term |
|---|---|
| D003398 | Craniosynostoses |
| ID | Term |
|---|---|
| D013580 | Synostosis |
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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