STUDY DESIGN: A prospective randomized comparative study. OBJECTIVE: To evaluate the effect of tranexamic acid (TXA) on decreasing perioperative blood loss in cervical laminoplasty, in which the surgical procedure is identical in all cases. SUMMARY OF BACKGROUND DATA: TXA, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, only a limited number of well-controlled spinal surgery trials have been conducted due to heterogeneity in the performed surgical procedures. METHODS:Forty consecutive patients with cervical compressive myelopathy were prospectively randomized into groups that received 15 mg/kg body weight of TXA or placebo intravenously before the skin incision was made. "French-door" cervical laminoplasty from C3 to C6 was performed for all patients by using a consistent procedure. Intraoperative and postoperative blood loss was compared between the groups. The surgery and follow-up were conducted at a single institution. RESULTS: There were no statistically significant differences between the TXA and control groups in terms of age, sex, body mass index, and operating time. Intraoperative blood loss in the TXA group (49.1 ± 30.6 mL) was not significantly different from that in the control group (63.4 ± 53.0 mL, P = 0.30). However, in the TXA group, postoperative blood loss during the first 16 hours was reduced by 37% as compared to the control group (132.0 ± 45.3 vs. 211.0 ± 41.5 mL; P < 0.01). The total blood loss (intraoperative plus postoperative blood loss during the first 40 hours) in the TXA group (264.1 ± 75.1 mL) was significantly lower than that in the control group (353.9 ± 60.8 mL, P < 0.01). No thromboembolic events or complications occurred in either group. CONCLUSION:TXA significantly reduced perioperative blood loss, primarily through a reduction in postoperative blood loss, in cervical laminoplasty.
RCT Entities:
STUDY DESIGN: A prospective randomized comparative study. OBJECTIVE: To evaluate the effect of tranexamic acid (TXA) on decreasing perioperative blood loss in cervical laminoplasty, in which the surgical procedure is identical in all cases. SUMMARY OF BACKGROUND DATA: TXA, an inhibitor of fibrinolysis, has proven to be effective in reducing perioperative blood loss in patients undergoing total hip and knee arthroplasty. However, only a limited number of well-controlled spinal surgery trials have been conducted due to heterogeneity in the performed surgical procedures. METHODS: Forty consecutive patients with cervical compressive myelopathy were prospectively randomized into groups that received 15 mg/kg body weight of TXA or placebo intravenously before the skin incision was made. "French-door" cervical laminoplasty from C3 to C6 was performed for all patients by using a consistent procedure. Intraoperative and postoperative blood loss was compared between the groups. The surgery and follow-up were conducted at a single institution. RESULTS: There were no statistically significant differences between the TXA and control groups in terms of age, sex, body mass index, and operating time. Intraoperative blood loss in the TXA group (49.1 ± 30.6 mL) was not significantly different from that in the control group (63.4 ± 53.0 mL, P = 0.30). However, in the TXA group, postoperative blood loss during the first 16 hours was reduced by 37% as compared to the control group (132.0 ± 45.3 vs. 211.0 ± 41.5 mL; P < 0.01). The total blood loss (intraoperative plus postoperative blood loss during the first 40 hours) in the TXA group (264.1 ± 75.1 mL) was significantly lower than that in the control group (353.9 ± 60.8 mL, P < 0.01). No thromboembolic events or complications occurred in either group. CONCLUSION:TXA significantly reduced perioperative blood loss, primarily through a reduction in postoperative blood loss, in cervical laminoplasty.