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The TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty)

Completed Research
The TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty)


Tranexamic Acid (“TXA”) has been proven safe and effective for hip and knee replacement surgery but its use in shoulder replacement is relatively new in Australia.

Tranexamic acid is a drug that helps clot formation in bleeding arteries around the surgical site. It effectively reduces blood loss after a joint replacement. The safety and benefits of the drug have been well documented in major orthopaedic procedures such as hip replacement, knee replacement, trauma and spinal surgery. TXA has repeatedly shown decreased blood loss, reduced need for transfusion, reduced related risk of infection, shortened time spent in recovery and reduced overall hospital stay.

To date only a handful of studies have been published regarding the safety and effectiveness of TXA in shoulder replacement surgery. The purpose of this study, therefore, is to test the hypothesis that the use of TXA during shoulder replacement surgery reduces surgical time and complexity, blood loss and swelling as well as post-operative pain and length of hospital stay.

TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty


  • To assess the efficiency of systemic tranexamic acid (TXA) in shoulder arthroplasty (aka “shoulder replacement surgery”).


This is a randomised controlled study involving 150 patients divided into two groups: one that receives the treatment drug (TXA) and one that receives a placebo (Saline).

Study Procedure

All consecutive patients requiring shoulder replacement surgery who meet the inclusion and exclusion criteria will be considered eligible for this study. After having read the information sheet and signed the consent form, patients will then be randomized to one of 2 groups: treatment (TXA) or placebo (Saline). Baseline patient characteristics such as age, sex and hand dominance will be recorded on a deidentified patient chart along with pre-operative haemoglobin and haematocrit levels. At the start of surgery, patients will be administered either 2gm of TXA in 20ml solution or 20ml of Saline intravenously. After surgery, drain output, need for transfusion, length of time in recovery room and overall stay will be recorded as well as post-operative haemoglobin and haematocrit levels (for comparison) along with any complications eg haematoma or infection. The surgeon will also rate the operation in terms of complexity and visibility (the hypothesis being that TXA will reduce the former and improve the latter).

Inclusion Criteria

  • Patients consented for anatomic or reverse shoulder arthroplasty
  • Patients who are capable of and have given informed consent to participate in this study

Exclusion Criteria

  • Patients allergic to tranexamic acid
  • Patients with a failed arthroplasty requiring revision
  • Patients with history of stroke
  • Patients with history of deep venous thrombosis or pulmonary embolism
  • Patients with cardiovascular disease, including coronary disease or peripheral arteriopathy
  • Patients with renal or liver failure
  • Patients with a known coagulopathy
  • Patients who are or may be pregnant
  • Patients that refuse a potential transfusion

Statistical Procedure

Univariate and multivariate analyses will be used to determine the correlation between systemic administration of TXA and the selected outcome criteria. Subgroup analysis will be carried out between the different types of prosthesis (reverse versus anatomic). Any P value <0.5 will be considered statistically significant.

Ethics and Governance

Approved by St Vincent’s Hospital Human Research Ethics Committee to be undertaken at the Mater Hospital Sydney. HREC reference HREC/16/SVH/105.

Approved by North Shore Private Ethics Committee to be undertaken at North Shore Private Hospital. HREC reference NSPHEC 2016-LNR-003.

TGA Clinical Trial Notification number CT-2016-CTN-03194-1 v2

ANZCTR trial number ACTRN1261600723482 viewable online here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370797&isReview=true


Patients who received TXA had a lower drain tube output at all time points: 41 mL vs. 133 mL at 6 hours, 75 mL vs. 179 mL at 12 hours, and 94 mL vs. 226 mL at 24 hours (P <.001 for all). They also had a higher postoperative hemoglobin (Hb) level (12.3 g/dL vs. 11.4 g/dL, P ¼.009), lower change in Hb level (1.7 g/dL vs. 2.3 g/dL, P ¼.011), lower total Hb loss (0.078 g vs. 0.103 g, P ¼.042), lower blood volume loss (0.55 L vs. 0.74 L, P ¼ .021), higher postoperative hematocrit level (36.7% vs. 34.6%, P ¼ .020), and lower hematocrit change (5.4% vs. 7.6%, P ¼.022). There was no significant difference in pain score or length of hospital stay, and no patients required a transfusion. We concluded therefore that a single dose of 2 g of intravenous TXA decreases blood loss and drain tube output in primary anatomic and reverse arthroplasty of the shoulder. No differences were detected in the occurrence of complications, need for transfusion, pain score, or length of hospital stay. With the mounting evidence now available, patients undergoing elective primary shoulder arthroplasty should be given intravenous TXA to decrease perioperative blood loss.


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  • National Statement on Ethical Conduct in Human Research (2007) – Updated December 2013 (the National Statement), Commonwealth of Australia, Canberra.


Lead Investigator:

Dr Ben Cass






Cunningham G, Hughes J, Borner B, Mattern O, Taha M, Smith MM, Young AA and Cass B. A Single Dose of Tranexamic Acid Reduces Blood Loss After Reverse and Anatomic Shoulder Arthroplasty: A Randomized Control Trial. Journal of Shoulder and Elbow Surgery 2021 – in press


Victorian Shoulder and Elbow Society Meeting, 2019


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