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

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OBJECTIVE

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.

METHODS

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 < 0.05.

RESULTS

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 < 0.001). There was no significant difference in number of dural lesions or postoperative spinal epidural hematomas, and there were no thromboembolic events.

CONCLUSIONS

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.

Clinical trial registration no.: NCT03714360 (clinicaltrials.gov)

ABBREVIATIONS ASA = American Society of Anesthesiologists; BMI = body mass index; TXA = tranexamic acid.

Article Information

Correspondence Signe Forbech Elmose: Center for Spine Surgery and Research, Middelfart, Denmark. signeelmose@hotmail.com.

INCLUDE WHEN CITING Published online April 12, 2019; DOI: 10.3171/2019.1.SPINE1814.

Disclosures Dr. Carreon reports financial relationships with Norton Healthcare (employee), AO Spine (consultant), the University of Southern Denmark and the University of Louisville (trips and travel), and nonfinancial relationships with the Scoliosis Research Society and the University of Louisville IRB as well as being on the editorial advisory boards of Spine Journal and Spine Deformity.

© AANS, except where prohibited by US copyright law.

Headings

Figures

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    CONSORT diagram of the study. Prepared using the CONSORT Flow Diagram template (available at http://www.consort-statement.org/).

  • View in gallery

    Histogram showing the distribution (percentage) of the operative time (minutes) data by randomization group. time_OP = operative time.

  • View in gallery

    Histogram showing the distribution (percentage) of estimated volume of total blood loss (ml) by randomization group.

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