The TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty)

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

Background

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

Objectives

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

Design

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.

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

AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY
ANZCTR trial number ACTRN1261600723482 viewable online here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370797&isReview=true

Status

Recruitment has begun. Results not expected until late 2017.

References

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  • Huang, F., Wu, Y., Yin, Z., Ma, G. & Chang, J. A systematic review and meta-analysis of the use of antifibrinolytic agents in total hip arthroplasty. Hip Int. J. Clin. Exp. Res. Hip Pathol. Ther. 25, 502–509 (2015).
  • Sukeik, M., Alshryda, S., Haddad, F. S. & Mason, J. M. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J. Bone Joint Surg. Br. 93, 39–46 (2011).
  • Kagoma, Y. K. et al. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb. Res. 123, 687–696 (2009).
  • Zhang, H., Chen, J., Chen, F. & Que, W. The effect of tranexamic acid on blood loss and use of blood products in total knee arthroplasty: a meta-analysis. Knee Surg. Sports Traumatol. Arthrosc. Off. J. ESSKA 20, 1742–1752 (2012).
  • McCormack, P. L. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs 72, 585–617 (2012).
  • Vigna-Taglianti, F. et al. Tranexamic acid for reducing blood transfusions in arthroplasty interventions: a cost-effective practice. Eur. J. Orthop. Surg. Traumatol. Orthopédie Traumatol. 24, 545–551 (2014).
  • Boyle, J. A. & Soric, M. M. Impact of Tranexamic Acid in Total Knee and Total Hip Replacement. J. Pharm. Pract. (2015). doi:10.1177/0897190015621813
  • Huang, F., Wu, D., Ma, G., Yin, Z. & Wang, Q. The use of tranexamic acid to reduce blood loss and transfusion in major orthopedic surgery: a meta-analysis. J. Surg. Res. 186, 318–327 (2014).
  • Hill, G. E., Frawley, W. H., Griffith, K. E., Forestner, J. E. & Minei, J. P. Allogeneic blood transfusion increases the risk of postoperative bacterial infection: a meta-analysis. J. Trauma 54, 908–914 (2003).
  • Friedman, R., Homering, M., Holberg, G. & Berkowitz, S. D. Allogeneic blood transfusions and postoperative infections after total hip or knee arthroplasty. J. Bone Joint Surg. Am. 96, 272–278 (2014).
  • Friedman, R. J., Gordon, E., Butler, R. B., Mock, L. & Dumas, B. Tranexamic acid decreases blood loss after total shoulder arthroplasty. J. Shoulder Elbow Surg. (2015). doi:10.1016/j.jse.2015.09.014
  • Phan, D. L., Ani, F. & Schwarzkopf, R. Cost Analysis of Tranexamic Acid in Anemic Total Joint Arthroplasty Patients. J. Arthroplasty 31, 579–582 (2016).
  • Gillespie, R., Shishani, Y., Joseph, S., Streit, J. J. & Gobezie, R. Neer Award 2015: A randomized, prospective evaluation on the effectiveness of tranexamic acid in reducing blood loss after total shoulder arthroplasty. J. Shoulder Elbow Surg. 24, 1679–1684 (2015).
  • Jameson, S. S. et al. Venous thromboembolic events are rare after shoulder surgery: analysis of a national database. J. Shoulder Elbow Surg. 20, 764–770 (2011).
  • Dattani, R., Smith, C. D. & Patel, V. R. The venous thromboembolic complications of shoulder and elbow surgery A systematic review. Bone Jt. J. 95, 70–74 (2013).
  • Zumstein, M. A., Pinedo, M., Old, J. & Boileau, P. Problems, complications, reoperations, and revisions in reverse total shoulder arthroplasty: A systematic review. J. Shoulder Elbow Surg. 20, 146–157 (2011).
  • Farshad, M. & Gerber, C. Reverse total shoulder arthroplasty—from the most to the least common complication. Int. Orthop. 34, 1075–1082 (2010).
  • Padegimas, E. M. et al. Periprosthetic shoulder infection in the United States: incidence and economic burden. J. Shoulder Elb. Surg. Am. Shoulder Elb. Surg. Al 24, 741–746 (2015).
  • Keyhani, S., Esmailiejah, A. A., Abbasian, M. R. & Safdari, F. Which Route of Tranexamic Acid Administration is More Effective to Reduce Blood Loss Following Total Knee Arthroplasty? Arch. Bone Jt. Surg. 4, 65–69 (2016).
  • Henry, D. A., Carless, P. A., Moxey, A. J., O’Connell, D., Stokes, B. J.,  Fergusson D. A. and Ker, K. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev19, 1 (2011).
  • Gandhi, R., Evans, H. M., Mahomed, S. R. and Mahomed, N. N. Tranexamic acid and the reduction of blood loss in total knee and hip arthroplasty: a meta-analysis. BMC Res Notes. 6, 184 (2011).
  • Poeran, J., Rasul, R., Suzuki, S., Danninger, T., Mazumdar, M., Opperer, M., Boettner, F. and Memtsoudis, S. G. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ, 349 (2014).
  • National Statement on Ethical Conduct in Human Research (2007) – Updated December 2013 (the National Statement), Commonwealth of Australia, Canberra.

sydney-shoulder-research-institute-projects

Lead Investigator:

Dr Ben Cass

Commenced:

October 2016

Category:

Current Projects

In Research - Current

The TXA 2 Study (Systemic Tranexamic Acid in Shoulder Arthroscopy and Rotator Cuff Repair)

In Research - Current

Shoulder Arthrodesis Long Term follow-up

TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty
In Research - Current

The TXA Study (Systemic Tranexamic Acid in Shoulder Arthroplasty)

The FUSE Study (Fitness band Used in Shoulder Evaluation)
In Research - Current

The FUSE Study – Fitness band Used in Shoulder Evaluation

The VAULT Study - Glenoid Version Measurement
In Research - Current

The VAULT Study – Glenoid Version Measurement

The VAULT Study (Reliability of Glenoid Version Measurement on 3D-corrected axial CT scan)
In Research - Current

Humeral Head to Greater Tuberosity Angle Study