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Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial

European Journal of Trauma and Emergency Surgery (2020)Cite this article

Abstract

Purpose

To investigate the efficacy and safety of intravenous tranexamic acid (IV-TXA) in patients undergoing intertrochanteric fracture surgery.

Methods

A total of 122 patients were included in this double-blinded trial and equally randomized to receive 1 g of IV-TXA or normal saline 10 min before incision and 3 h later. The primary efficacy outcome was calculated hidden blood loss (HBL). The secondary efficacy outcome was allogeneic erythrocyte transfusion rate during hospitalization. Safety outcome was a composite of thromboembolic events including deep venous thrombosis (DVT) up to 90 days. A meta-analysis combining this study with previous randomized controlled trials in hip fracture surgery (total sample size: 1112 patients) was also conducted.

Results

The mean HBL in TXA group (640.96 ± 421.63 ml) was significantly lower than that in placebo group (1010.11 ± 398.96 ml, P < 0.001). The rate of erythrocyte transfusions was 29.5% in TXA group and 60.7% in placebo group (P = 0.001). The incidence of thromboembolic events at 90 days was 4.9% in TXA group and 1.6% in placebo group (P = 0.619). The updated meta-analysis showed that IV-TXA significantly reduced erythrocyte transfusion in hip fracture surgery (risk ratio 0.60, 95% confidence intervals 0.53–0.68), and IV-TXA caused no increased risk of thromboembolic events (risk difference 0.01, 95% confidence intervals − 0.02–0.04).

Conclusion

IV-TXA could effectively reduce the HBL and allogeneic erythrocyte transfusion requirements in patients undergoing intertrochanteric fracture surgery without an increase of thromboembolic events including DVT.

Trial registration

Clinical trials: safety and efficiency of tranexamic acid in hip fracture patients. Date of registration: August 31, 2018. Trial registration number: ChiCTR1800018110.

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Acknowledgements

The authors sincerely acknowledge the entire staffs of the Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, who offered assistance in the coursing of this study.

Funding

This study was funded by the Research Project of Mianyang Municipal Health and Family Planning Commission (201812) and General Incubation Project of The Third Hospital of Mianyang (201944).

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Author notes

  1. Shaoyun Zhang, Cong Xiao, and Wei Yu contributed equally to this work and should be considered as equal first authors.

Affiliations

  1. Department of Orthopedics, The Third Hospital of Mianyang, Sichuan Mental Health Center, No. 190 The East Jiannan Road, Mianyang, 621000, China

    Shaoyun Zhang, Cong Xiao, Wei Yu, Nengji Long, Fenglai He, Peng Cai, Kairong Luo & Yishan Jiang

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  1. Shaoyun Zhang
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  2. Cong Xiao
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Contributions

Shaoyun Zhang, Cong Xiao, and Wei Yu reviewed the database, carried out the statistical analysis, conceived the design of the study, and prepared the manuscript. Nengji Long, Fenglai He, Peng Cai, and Kairong Luo contributed to study design, assisted with the data collection and revision of the manuscript. Cong Xiao and Yishan Jiang performed the surgery, obtained IRB approval, and oversaw the engineering efforts. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Yishan Jiang.

Ethics declarations

Conflict of interest

All authors declare no conflict of interest.

Ethical approval

The trial was approved by the institutional review board of our hospital (2018–009) and registered at the International Clinical Trial Registry (ChiCTR1800018110).

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Zhang, S., Xiao, C., Yu, W. et al. Tranexamic acid safely reduces hidden blood loss in patients undergoing intertrochanteric fracture surgery: a randomized controlled trial. Eur J Trauma Emerg Surg (2020). https://doi.org/10.1007/s00068-020-01387-0

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  • DOI: https://doi.org/10.1007/s00068-020-01387-0

Keywords

  • Tranexamic acid
  • Intertrochanteric fracture
  • Blood loss
  • Transfusion
  • Deep vein thrombosis
  • Thromboembolic event