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The effectiveness of low-dose and high-dose tranexamic acid in posterior lumbar interbody fusion: a double-blinded, placebo-controlled randomized study

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Abstract

Purpose

Tranexamic acid is a proven drug used for reduction of intraoperative blood loss in spinal surgery. However, optimal dosing considering risk/benefits is not well established owing to the heterogeneity in patient selection and surgical procedures of previous studies. This study aimed to evaluate the effectiveness and safety of various tranexamic acid regimens in reducing perioperative blood loss in single-level posterior lumbar interbody fusion (PLIF).

Methods

Patients were randomly grouped into three different interventions: low-dose tranexamic acid (LD), high-dose tranexamic acid (HD), and placebo-controlled (PC) groups. The HD and LD groups received 10 and 5 mg/kg of bolus loading dose and 2 and 1 mg/kg of continuous infusion until 5 h after surgery, respectively. Data on patient demographics and preoperative and 24-h postoperative laboratory values were collected. Outcome parameters include intraoperative blood loss, 24-h postoperative blood loss, and blood loss during removal of the last drain.

Results

Seventy-two patients (mean age 63.3 ± 7.6 years) showed similar baseline characteristics. Intraoperatively, blood loss was reduced by the administration of tranexamic acid (P = 0.04), contributed predominantly by a difference between the LD and HD groups (123 mL; P < 0.01). The 24-h postoperative blood loss was reduced (P < 0.01), contributed predominantly by a difference between the PC and LD groups (144 mL; P = 0.02). During the removal of the last drain, statistical difference was found between the PC and HD groups (125 mL; P = 0.00). No complications or side effects from tranexamic acid use were noted.

Conclusion

Tranexamic acid administration for single-level PLIF was effective and safe in reducing perioperative blood loss in a dose-dependent manner. An HD regimen comprising 10 mg/kg of bolus loading dose and 2 mg/kg/h of continuous infusion is recommended.

Level of evidence

Level 1 study according to Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence.

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Authors and Affiliations

  1. Department of Orthopedic Surgery, Kyung Hee University Hospital at Gangdong, Seoul, South Korea

    Ki-Tack Kim, Cheung-Kue Kim, Yong-Chan Kim & Se Jung Hong

  2. Department of Medicine, Graduate School, Kyung Hee University, Seoul, South Korea

    Hyung-Suk Juh

  3. Department of Orthopedic Surgery, Park Weon Wook Hospital, Busan, South Korea

    Hyo-Jong Kim

  4. Department of Orthopedic Surgery, Samsung Changwon Hospital, Sungkyunkwan University, School of Medicine, Changwon, South Korea

    Hyeon-Soo Kim

  5. University Orthopaedics, Hand and Reconstructive Microsurgery Cluster (UOHC), National University Health System (NUHS), Singapore, Singapore

    Hwee Weng Dennis Hey

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  1. Ki-Tack Kim
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Correspondence to Cheung-Kue Kim.

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Conflict of interest

Cheung Kue-Kim, Ki-Tack Kim, Yong-chan Kim, Hyung-Suk Juh, Hyo-jong Kim, Hyeon-Soo Kim, Se jung Hong, and Hwee Weng Dennis Hey declare that they have no conflict of interest.

Ethics approval

Ethics approval was obtained from the institutional review board before the commencement of this study. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.

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No funds were received in support of this work.

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Kim, KT., Kim, CK., Kim, YC. et al. The effectiveness of low-dose and high-dose tranexamic acid in posterior lumbar interbody fusion: a double-blinded, placebo-controlled randomized study. Eur Spine J 26, 2851–2857 (2017). https://doi.org/10.1007/s00586-017-5230-4

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  • DOI: https://doi.org/10.1007/s00586-017-5230-4

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