Intravenous single dose of tranexamic acid safely reduces blood loss and the need for transfusion in elderly patients with hip fracture. A randomized double-blinded controlled trial at 1-year follow-up

Miralles-Muñoz Francisco A, Martin-Grandes Rosario, Martinez-Mendez Daniel, Mahiques-Segura Gerard, Lizaur-Utrilla Alejandro, Vizcaya-Moreno María Flores
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Abstract

Background: A hip fracture usually presents significant blood loss in the perioperative period, with a transfusion rate of 20-60%. In order to reduce the complications associated with this procedure, the administration of Tranexamic Acid (TXA) has been implemented in the treatment of perioperative anemia. The objectives were to evaluate the effectiveness and safety of a single dose of intravenous Tranexamic Acid (TXA) in reducing perioperative blood loss and the requirement for transfusion in elderly patients undergoing hip fracture surgery within one postoperative year. Methods: A double-blind randomized controlled trial was conducted on 129 patients with hip fractures. After randomization, at the start of the surgery, 65 patients received a single dose of 1 gram of intravenous TXA (TXA group), and 64 received a placebo (placebo group). The primary effectiveness outcomes were the total blood loss and transfusion rate. The primary safety outcome was the rate of thromboembolic events. Data on surgical or medical infection, readmission and death were also collected. Results: The TXA group had a significant decrease in blood loss (p = 0.006) and requirement for transfusion (p < 0.001) compared with the placebo group. Likewise, there were no thromboembolic events in the TXA group and seven in the placebo group (p = 0.006). Mortality within 1-year postoperatively was not significantly different (p = 0.115). Conclusion: Using a single dose of intravenous TXA at the start of the surgery significantly reduces blood loss and the requirement for transfusion without increasing the risk of thromboembolic events or mortality within 1-year postoperatively in patients with hip fracture undergoing surgery. Registration number: NCT03211286. https://clinicaltrials.gov/ct2/show/NCT03211286. Level of evidence: I.
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静脉注射单剂量氨甲环酸可安全减少老年髋部骨折患者的失血量和输血需求。为期一年的随机双盲对照试验
背景:髋部骨折患者在围手术期通常会出现大量失血,输血率高达 20-60%。为了减少与该手术相关的并发症,氨甲环酸(TXA)已被用于治疗围手术期贫血。目的是评估单剂量静脉注射氨甲环酸(TXA)在减少老年髋部骨折手术患者术后一年内围手术期失血量和输血需求方面的有效性和安全性。方法:双盲随机对照试验对 129 名髋部骨折患者进行了双盲随机对照试验。随机分组后,在手术开始时,65 名患者接受单剂量 1 克静脉注射 TXA(TXA 组),64 名患者接受安慰剂(安慰剂组)。主要有效性结果是总失血量和输血率。主要安全性结果为血栓栓塞事件发生率。此外,还收集了手术或内科感染、再入院和死亡的数据。结果与安慰剂组相比,TXA 组的失血量(p = 0.006)和输血需求(p < 0.001)明显减少。同样,TXA 组未发生血栓栓塞事件,而安慰剂组发生了 7 起(p = 0.006)。术后一年内的死亡率无明显差异(p = 0.115)。结论:在手术开始时使用单剂量静脉注射 TXA 可显著减少失血量和输血需求,同时不会增加接受手术的髋部骨折患者发生血栓栓塞事件的风险或术后 1 年内的死亡率。注册编号:NCT03211286:NCT03211286。https://clinicaltrials.gov/ct2/show/NCT03211286。证据级别:I.
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