Intravenous tranexamic acid ("TXA") and its effect on operating conditions, blood loss, post-operative pain and complications in patients undergoing total shoulder replacement.

Effect of systemic tranexamic acid use on operating conditions, blood loss, post-operative pain and complications in patients undergoing shoulder arthroplasty.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616000723482

Enrollment

Registered

2016-06-01

Start date

2016-10-17

Completion date

2017-08-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This was a multicentre multisurgeon prospective doubleblinded randomized and controlled trial looking at the effectiveness of single dose intravenous administration of Tranexamic Acid (TXA) in patients undergoing shoulder arthroplasty. The aim of this study was to extend Level I category evidence of the known benefits of TXA to shoulder arthroplasty. The primary objective of this study was to test the hypothesis that systemic use of Tranexamic acid improves operating conditions, decreases blood loss, postoperative pain and complications such as haematoma and need for transfusion. The secondary objective was to carry out subgroup analysis between reverse and anatomical shoulder arthroplasty with the hypothesis that reverse causes more blood loss than anatomic. All consecutive patients presenting to an elective orthopaedic consultation with a failed nonoperative management of shoulder arthritis indicated for shoulder arthroplasty were considered eligible for this study. After having been screened for inclusion and exclusion criteria, read the information sheet and signed the consent form, patients were blindly randomized to one of 2 groups: Systemic TXA or Control. Patients’ general demographic characteristics such as age, sex, dominance, diagnosis, BMI, American Society of Anaesthesia (ASA) score and other relevant comorbidities were collected in a deidentified database locked on a password-protected computer. During the surgery, patients were administered either 2mg of intravenous TXA or a placebo equivalent (saline solution). Analysed outcome variables included: surgeon’s rating of surgical field visibility and overall appreciation of the complexity of the procedure, operative time, pre- and postoperative haemoglobin and haematocrit levels, drain output at 6,12 and 24 hours, need for transfusion, occurrence of postoperative haematoma, postoperative pain Visual Analog Scale (pVAS), time spent in recovery room and hospital room.

Interventions

Group 1 (TXA group) will receive 2000mg (20ml) of Tranexamic Acid (TXA) intravenously 5 minutes before incision.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients who have consented for anatomic or reverse shoulder arthroplasty under one of the principal investigators. 2. Patients who are capable of and have given informed consent for their participation in this study.

Exclusion criteria

1. Patients allergic to tranexamic acid 2. Patients with a failed arthroplasty requiring revision 3. Patients with history of deep venous thrombosis or pulmonary embolism 4. Patients with cardiovascular disease, including coronary disease or peripheral arteriopathy 5. Patients with renal or liver failure 6. Patients with a known coagulopathy 7. Patients that refuse a potential transfusion

Outcome results