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Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial.
This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.In this prospective, randomized trial, 62 adult patients scheduled for elective thoracolumbar stabilization involving three or more levels were assigned to receive either low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion or high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion.TXA was administered intravenously 15 minutes before incision.
Intraoperative blood loss, transfusion requirements, perioperative laboratory values, and complications (thromboembolic, neurological, renal, allergic, and seizure-related) were recorded. Patients were monitored for 48 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low-dose tranexamic acid | Active Comparator | low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion |
|
| high-dose tranexamic acid | Active Comparator | high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-dose TXA | Drug | low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Blood Loss [Milliliters] | The total amount of blood lost during surgery, measured in milliliters. | During the operation |
| Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants] | Number of participants who required intraoperative erythrocyte suspension (ES) transfusion. | During the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL] | Hemoglobin values measured at 24 and 48 hours after surgery. | 24 and 48 hours postoperatively |
| Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kartal Dr. Lütfi Kırdar Şehir Hastanesi | Istanbul | 34865 | Turkey (Türkiye) |
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| high-dose TXA | Drug | high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion |
|
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Hematocrit levels measured at 24 and 48 hours after surgery.
| 24 and 48 hours postoperatively |
| Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³] | Platelet count measured at 24 and 48 hours after surgery. | 24 and 48 hours postoperatively |
| Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L] | Biochemical Parameters | 24 and 48 hours postoperatively |
| Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L] | Biochemical Parameters | 24 and 48 hours postoperatively |
| Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL] | Biochemical Parameters | 24 and 48 hours postoperatively |
| Creatinine Level at 24 and 48 Hours [mg/dL] | Biochemical Parameters | 24 and 48 hours postoperatively |
| Incidence of Postoperative Nausea and Vomiting [Number of Participants] | Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration. | First 48 hours postoperatively |
| Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants] | Number of participants experiencing serious adverse events attributable to tranexamic acid use. | First 48 hours postoperatively |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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