The efficacy and safety of intravenous tranexamic acid in patients with posterior operation of multilevel thoracic spine stenosis: a prospective randomized controlled trial

Abstract

Background This study was a randomized controlled trial to evaluate efficacy and safety of the usage of intravenous tranexamic acid during posterior operation of multilevel thoracic spine stenosis for controlling perioperative blood loss. Methods Sixty eight patients with multilevel thoracic spine stenosis were randomized into the tranexamic acid group receiving 15 mg/kg body weight before the skin incision was made and 1 mg/kg body weight per hour during operation or the control group receiving the same dose of placebo (0.9% sodium chloride solution) intravenously. Pedicle screw fixation, laminectomy and selective discectomy were performed. Intraoperative and perioperative total blood loss were compared. The necessity and amount for blood transfusion, blood coagulation function, durations of postoperative hospital stays were compared. The complications of tranexamic acid were also investigated such as cardiovascular and cerebrovascular events, lower limb venous thrombosis. Results There were no statistically significant differences in age, gender, body mass index, ASA status, pathology required surgery, preoperative hemoglobin, operation time, laminectomy segments and discectomy segments between the tranexamic acid and control groups. The intraoperative blood loss (455.9 ± 206.6 ml vs 580.6 ± 224.3 ml, p < 0.05) and total blood loss (675.3 ± 170.3 ml vs 936.8 ± 306.4 ml, p < 0.01) in tranexamic acid group were significant lower than those in control group. The means of blood unit transfused (2.5 ± 1.0 vs 4.7 ± 2.4, p < 0.05) and Hb reduction in 48 h (22.5 ± 3.4 g/L vs 25.3 ± 3.9 g/L, p < 0.01) were significantly lower in tranexamic acid group than that in control group. There were no statistically significant differences in blood coagulation function pre-operation or 48 h post-operation between the tranexamic acid and the control groups. The requirements for patients to receive blood transfusion were fewer and durations of post-operational hospital stays were shorter in the tranexamic acid group, however, the difference did not achieve statistical significance. There was no significant difference in superficial or deep venous thrombosis of lower limbs or deterioration of neurological function between tranexamic acid group and control group. Conclusions Application of intravenous tranexamic acid significantly reduces intraoperative and perioperative total blood loss without significant side effects in posterior operation of multilevel thoracic spine stenosis. Trial registration At Chinese Clinal Trial Registry. http://www.chictr.org.cn/, ChiCTR2100054221. Registered on 11/12/2021.

Evaluation of the safety of tranexamic acid use in pediatric patients undergoing spinal fusion surgery: a retrospective comparative cohort study

“…Meanwhile, research supporting TXA efficacy and safety in adult spine surgery has also been increasing [44,45]. Multiple recent studies, including one randomized control trial of 68 thoracic spine stenosis patients and a retrospective analysis of 122 patients undergoing lumbar fusion, did not find any associated side effects with TXA use including the incidence of DVTs [46,47]. Our findings are in line with this growing body of work demonstrating safety of TXA use in spine surgery.…”

The efficacy and safety of different does of intravenous tranexamic acid on blood loss in fresh foot and ankle fractures: a prospective, randomized controlled study

“…For orthopedic trauma, TXA can reduce hidden blood loss related to intertrochanteric fractures and tibial plateau fractures but does not increase the risk of postoperative venous thromboembolism [ 25 – 27 ]. In spinal surgery, TXA can significantly reduce the total perioperative blood loss volume without obvious side effects [ 28 , 29 ].…”

Postoperative clinical outcomes with and without short-term intravenous tranexamic acid after posterior lumbar interbody fusion: A prospective cohort study

“…TXA is widely used in lumbar fusion surgery because it reduces IBL, OT, LOS, and even blood transfusion rates. [9–34] A systematic review and meta-analysis by Gong et al demonstrated that intravenous TXA during PLIF surgery is safe and can help reduce surgical blood loss; however, the authors concluded that it does not reduce transfusion rates. [10] Bai et al made similar conclusions.…”

“…[11,12] In addition, more than one study has found that intraoperative TXA use can reduce PDV and LOS. [13][14][15][16][17][18] However, no studies have reported whether using TXA or not using TXA within 24 hours after surgery will result in different perioperative clinical outcomes.…”

“…Several clinicians have adopted the use of antifibrinolytics, particularly tranexamic acid (TXA), in posterior lumbar fusion surgeries, and the TXA use has been demonstrated to help improve the perioperative clinical outcomes, such as reduction in intraoperative blood loss (IBL) and operative time (OT), transfusion rates, hidden blood loss, and length of hospital stay (LOS). [9–34] However, to date, studies comparing the differences in perioperative clinical outcomes with and without postoperative TXA administration are lacking. The impact of the postoperative TXA use on reducing postoperative drainage volume (PDV), LOS, and the rate of postoperative blood or albumin transfusions remains to be elucidated.…”