Blood Loss, Surgical, Degenerative Spine Disease, Spinal Disorders
Conditions
Keywords
Tranexamic acid, Spinal surgery, Bleeding, Blood transfusion
Brief summary
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.
Detailed description
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.
Interventions
DRUGlow-dose TXA
low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion
DRUGhigh-dose TXA
high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Between 18-65 years * Scheduled for elective ≥3-level spinal stabilization surgery under general anesthesia
Exclusion criteria
* History of thromboembolic events * Myocardial infarction * Stroke * Hepatic or renal failure, * Known allergy to TXA * Bleeding or coagulation disorders, * ASA physical status IV * Trauma or tumor surgery * Refusal to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss [Milliliters] | During the operation | The total amount of blood lost during surgery, measured in milliliters. |
| Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants] | During the operation | Number of participants who required intraoperative erythrocyte suspension (ES) transfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³] | 24 and 48 hours postoperatively | Platelet count measured at 24 and 48 hours after surgery. |
| Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L] | 24 and 48 hours postoperatively | Biochemical Parameters |
| Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L] | 24 and 48 hours postoperatively | Biochemical Parameters |
| Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL] | 24 and 48 hours postoperatively | Hemoglobin values measured at 24 and 48 hours after surgery. |
| Creatinine Level at 24 and 48 Hours [mg/dL] | 24 and 48 hours postoperatively | Biochemical Parameters |
| Incidence of Postoperative Nausea and Vomiting [Number of Participants] | First 48 hours postoperatively | Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration. |
| Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants] | First 48 hours postoperatively | Number of participants experiencing serious adverse events attributable to tranexamic acid use. |
| Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL] | 24 and 48 hours postoperatively | Biochemical Parameters |
| Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)] | 24 and 48 hours postoperatively | Hematocrit levels measured at 24 and 48 hours after surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed