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

Phase 4

Completed

• Conditions: Blood loss in total shoulder arthroplasty; Musculoskeletal - Osteoarthritis; Surgery - Other surgery

• Registration Number: ACTRN12616000723482
• Lead Sponsor: Dr Benjamin Cass

Brief Summary

Our results show that a single dose of tranexamic acid (TXA) administered intravenously at the start of shoulder replacement surgery (arthroplasty) decreases blood loss and drain tube output regardless of the type of implant used (i.e. anatomic aka “total” or reverse). Patients who received TXA had lower drain outputs at all time points: 41ml vs 133ml at 8 hours, 75ml vs 179ml at 16 hours and 94ml vs 226ml at 24 hours. They also had higher postoperative Haemaglobin (Hb) (12.3 vs 11.4), lower change in Hb (1.7 vs 2.3), lower total Hb loss (0.078g vs 0.103g), lower blood volume loss (0.55L vs 0.74L), higher postoperative Haematocrit (36.7 vs 34.6) and lower Haematocrit change (5.4 vs 7.6). We found no difference in pain scores between the group that received TXA and the group that received Placebo. We also found no difference on the other measured outcomes (field visibility, operation complexity or time, time spent in the recovery bay or time spent in hospital overall).

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-01
• Study Completion: 2017-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in haemaglobin level as measured by the difference between pre-operative and post-operative levels as assessed by serum assay.[Pre-operative haemaglobin will be assessed the day before operation. Post-operative haemaglobin will be assessed in the morning of the first day after operation. ];Change in haemocrit as measured by the difference between pre-operative and post-operative levels as assessed by serum assay.[Pre-operative haemocrit will be assessed the day before operation. Post-operative haemocrit will be assessed in the morning of the first day after operation. ]