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Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis—a prospective, stratified, randomized, controlled trial

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Abstract

Purpose

This prospective, stratified, randomized, single-blind, placebo-controlled multicentre study investigated the safety and effectiveness of reducing blood loss and preventing venous thromboembolism (VTE) during posterior lumbar interbody fusion (PLIF) in patients with stenosis or spondylolisthesis using the combination of tranexamic acid (TXA) and rivaroxaban.

Methods

The Autar score was evaluated in patients after admission. Patients with an Autar score ≤ 10 were randomized to group A or B. Group A was the placebo-controlled group. Patients in group B were treated with 1 g TXA via intravenous injection and 1 g TXA for external use. Patients with an Autar score > 10 were randomized to group C or D. Patients in group C were treated with 10-mg rivaroxaban qd for 35 days after surgery. Patients in group D received the same treatment as those in group B intra-operatively and as those in group C post-operatively.

Results

A total of 599 patients from eight hospitals participated in this clinical trial. The total blood loss, intra-operative blood loss, and drainage volume were reduced by the administration of TXA (group A vs group B, P < 0.01; group C vs group D, P < 0.01), and the blood transfusion rate was also decreased (group A vs group B, P < 0.01; group C vs group D, P < 0.01). There were no significant differences (P > 0.05) in the VTE incidence rates among group A and group B. In patients with high-risk thrombosis, the number of patients with VTE was only three and seven after the application of rivaroxaban. Epidural haematoma was not discovered in any patients in our trial.

Conclusion

The combined application of tranexamic acid and rivaroxaban significantly reduced the amount of blood loss and the transfusion rate during PLIF surgery and avoided an increase in the probability of thrombosis and the occurrence of epidural haematoma.

Trial registration number and date of registration

ChiCTR-1800016430

2018-06-01

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Data availability

We declared that materials described in the manuscript, including all relevant raw data, will be freely available to any scientist wishing to use them for non-commercial purposes, without breaching participant confidentiality. The datasets generated during the current study are available in the Figshare repository https://figshare.com/s/b4128bd83127f2056e96.

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Author information

Author notes

  1. Lu Zhang, Yanming Li and Dong Liu contributed equally to this work.

Authors and Affiliations

  1. Department of Spine Surgery, Qilu Hospital, Shandong University, 107, West Culture Road, Lixia District, Jinan, China

    Lu Zhang, Guangjun Jiao, Wenliang Wu, Hongliang Wang, Haichun Liu & Yunzhen Chen

  2. Department of Shandong University Spine and Spine Cord Disease Research Center, Jinan, Shandong, China

    Lu Zhang, Guangjun Jiao, Wenliang Wu, Hongliang Wang, Haichun Liu & Yunzhen Chen

  3. Department of Spine Surgery, Affiliated Hospital of Jining Medical University, 89 Guhuai Road, Jining, China

    Yanming Li & Chunyang Meng

  4. Department of Spine Surgery, Binzhou Medical University Hospital, 661 Huanghe 2nd Road, Binzhou, China

    Dong Liu & Zhaozhong Sun

  5. Department of Spine Surgery, Shandong Provincial Qianfoshan Hospital, 16766 Jingshi Road, Jinan, China

    Xing Xiao

  6. Department of Spine Surgery, The First Hospital of Zibo City, 4, East Emeishan Road, Boshan District, Zibo, China

    Tingjin Guan

  7. Department of Spine Surgery, Dezhou People’s Hospital, 1166, Dongfanghong West Road, Decheng District, Dezhou, China

    Hongwei Yue

  8. Department of Spine Surgery, Shandong Provincial Hospital of Traditional Chinese Medicine, 16369 Jingshi Road, Jinan, China

    Haipeng Xue

  9. Department of Spine Surgery, Linyi Central Hospital, 17, Jiankang Road, Yishui County, Linyi, China

    Hongming Zhou

Authors
  1. Lu Zhang
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Corresponding author

Correspondence to Yunzhen Chen.

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Conflict of interest

The authors declare that they have no potential conflict of interest.

Ethics approval

This retrospective, stratified, randomized, single-blind, placebo-controlled multicentre study was approved by the Medical Ethics Committee of Qilu Hospital of Shandong University (no. 2018059) and was registered in the Chinese Clinical Trial Registry (ChiCTR-1800016430).

Consent to participate

All subjects were aware of the clinical trial and agreed to participate.

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All authors have approved the manuscript and agree with submission to International Orthopaedics.

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Zhang, L., Li, Y., Liu, D. et al. Combined use of tranexamic acid and rivaroxaban in posterior lumbar interbody fusion safely reduces blood loss and transfusion rates without increasing the risk of thrombosis—a prospective, stratified, randomized, controlled trial. International Orthopaedics (SICOT) 44, 2079–2087 (2020). https://doi.org/10.1007/s00264-020-04699-3

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  • DOI: https://doi.org/10.1007/s00264-020-04699-3

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