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Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis:a single-blinded, randomised, parallel-controlled study protocol in China
  1. Bing-Xin Kang,
  2. Hui Xu,
  3. Chen-Xin Gao,
  4. Sheng Zhong,
  5. Jing Zhang,
  6. Jun Xie,
  7. Song-Tao Sun,
  8. Ying-Hui Ma,
  9. Wei-Tao Zhai,
  10. Lian-Bo Xiao
  1. Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China
  1. Correspondence to Dr Lian-Bo Xiao; 13701888178{at}163.com

Abstract

Introduction This clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).

Methods and analysis A randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50–75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.

Ethics and dissemination The Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.

Trial registration number ChiCTR1900025013.

  • tranexamic acid
  • total knee arthroplasty
  • perioperative blood management
  • knee
  • paediatric orthopaedics
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Footnotes

  • B-XK and HX are joint first authors.

  • B-XK and HX contributed equally.

  • Contributors B-XK, HX and L-BX conceived the study while B-XK and HX drafted the study protocol. The study protocol was designed by C-XG, SZ, JZ, JX, S-TS, Y-HM and W-TZ. All authors approved the final manuscript of this study protocol.

  • Funding This work will be supported by the Foundation of Health and Family planning Commission of Shanghai (Grant No. ZY (2018–2020)-FWTX-6023).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.