Effect of systemic tranexamic acid use on operating conditions, blood loss, post-operative pain and complications in patients undergoing shoulder arthroplasty.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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