Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications

Abstract

<jats:sec><jats:title>OBJECTIVE</jats:title><jats:p>The purpose of this study was to investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery—specifically with respect to operative time, estimated blood loss, and complications. Studies have shown that TXA reduces blood loss during major spine surgery. There have been no previous studies on the effect of TXA in minor lumbar spine surgery in which these variables have been evaluated.</jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p>The authors enrolled patients with ASA grades 1 to 2 scheduled to undergo lumbar decompressive surgery at Middelfart Hospital into a double-blind, randomized, placebo-controlled, parallel-group study. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA, or a history of convulsion were excluded. Patients were randomly assigned, in blocks of 10, to one of 2 groups, TXA or placebo. Anticoagulation therapy was discontinued 2–7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10 mg/kg) or an equivalent volume of saline solution (placebo). Independent t-tests were used to compare differences between the 2 groups, with statistical significance set at p &lt; 0.05.</jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p>Of the 250 patients enrolled, 17 patients were excluded, leaving 233 cases for analysis (117 in the TXA group and 116 in the placebo group). The demographics of the 2 groups were similar, except for a higher proportion of women in the TXA group (TXA 50% vs placebo 32%, p = 0.017). There was no significant between-groups difference in operative time (49.53 ± 18.26 vs 54.74 ± 24.49 minutes for TXA and placebo, respectively; p = 0.108) or intraoperative blood loss (55.87 ± 48.48 vs 69.14 ± 83.47 ml for TXA and placebo, respectively; p = 0.702). Postoperative blood loss measured from drain output was 62% significantly lower in the TXA group (13.03 ± 21.82 ml) than in the placebo group (34.61 ± 44.38 ml) (p &lt; 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.</jats:p></jats:sec><jats:sec><jats:title>CONCLUSIONS</jats:title><jats:p>Tranexamic acid did not have a statistically significant effect on operative time, intraoperative blood loss, or complications. This study gives no evidence to support the routine use of TXA during minor lumbar decompressive surgery.</jats:p><jats:p>Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)</jats:p></jats:sec>

Comparison of Intravenous versus Topical Tranexamic Acid in Nondeformity Spine Surgery: A Meta‐Analysis

“…Zhang et al [17] in 2019 conducted a meta-analysis of 11 studies, a total of 748 patients, and were able to show that intravenous TXA could effectively reduce IBL and perioperative blood transfusion during multilevel spine surgery, and could restore Hb level after surgery. Elmose et al [18] demonstrated that there was no statistically significant effect Total (95% CI) Heterogeneity: tau 2 = 0.04, chi 2 = 14.27, df = 8 (P = 0.08); I 2 = 44% Test for overall effect: Z = 3.15 (P = 0.002) Test for subgroup differences: chi 2 = 0.75, df = 1 (P = 0.39); I 2 = 0% - Heterogeneity: tau 2 = 0.00, chi 2 = 0.15, df = 2 (P = 0.93); I 2 = 0% Test for overall effect: Z = 3.99 (P < 0.0001)…”

“…Duan et al 2018 Wu et al 2016 Zheng et al 2019 Subtotal (95% CI) Heterogeneity: tau 2 = 3.31, chi 2 = 22.60, df = 2 (P < 0.0001); I 2 = 91% Test for overall effect: Z = 0.27 (P = 0.79) Total (95% CI) Heterogeneity: tau 2 = 2.97, chi 2 = 66.85, df = 5 (P < 0.00001); I 2 = 93% Test for overall effect: Z = 0.56 (P = 0.58) Test for subgroup differences: chi 2 = 1.55, df = 1 (P = 0.21); I 2 = 35.3% - of intravenous TXA on intraoperative blood loss, operative time, or complications during minor lumbar spine surgery. However, intravenous TXA may have potentially adverse effects on patients, including DVT, PE, and myocardial infarction [18,19]. Intravenous TXA is usually avoided in patients with a previous history of myocardial infarction, DVT/ PE, stroke, and seizure disorders [20][21][22][23].…”

Local Infiltration of Tranexamic Acid in Breast Reduction for Symptomatic Macromastia

“…For instance, previous studies had shown a reduction in blood loss when using TXA during major spine surgery. Therefore, Elmose et al 17 conducted a double-blind randomized controlled trial to investigate the impact of TXA in minor lumbar spine surgery. They found no statistically significant impact on operative time, intraoperative blood loss, or complications much like our findings 17 .…”

“…Therefore, Elmose et al 17 conducted a double-blind randomized controlled trial to investigate the impact of TXA in minor lumbar spine surgery. They found no statistically significant impact on operative time, intraoperative blood loss, or complications much like our findings 17 . In addition, our preexisting protocol of tumescent solution infiltration in breast reduction surgery may already achieve a significant level of reduction in blood loss and operative time, rendering the potential impact of TXA minimal at best.…”

Enhanced Recovery Components for Posterior Lumbar Spine Fusion

“…Despite heterogeneity in dosing regimens for TXA, good evidence in support of TXA exists including metaanalyses of randomized control trials demonstrating efficacy in reducing blood transfusions and minimizing complications associated with major and complex multilevel spinal surgery. [36][37][38] The benefits versus risks of administration of TXA for minor lumbar surgery is disputable, 39 and published ERAS protocols typically reserve its use for complex cases. 2 Thus, the low use of TXA in our analysis is likely due to a majority of the cases being minor or a low number of levels fused ( ≤ 3 levels).…”