背景:氨甲环酸(TXA)是一种廉价且广泛可用的药物,可减少心脏和骨科手术中的失血和红细胞(RBC)输血。虽然在这些手术中使用TXA是常规的,其在其他手术中的有效性和安全性,包括肿瘤手术,具有可比性的输血率是不确定的。我们的主要目标是评估在接受大型非心脏手术的患者中实施常规TXA的医院政策是否可以减少RBC的输血而不增加血栓形成的风险。
方法:务实,基于注册表,失明,加拿大10个地点的集群交叉随机对照试验,接受非心脏手术高危红细胞输血的患者。站点以4周的间隔随机分配到术中TXA或匹配安慰剂的医院政策。TXA在皮肤切口处给予1克,然后在皮肤闭合前再加入1克。共同的主要结果是(1)有效性,评估为住院期间输注红细胞的患者比例和(2)安全性,评估90天内诊断为静脉血栓栓塞症的患者比例。次要结果包括:(1)输血:输血的红细胞单位数量(在医院和患者层面);(2)安全性:在医院诊断心肌梗塞,中风,深静脉血栓形成或肺栓塞;(3)临床:住院时间,重症监护室入院,医院生存,90天存活和存活和出院至第30天的天数;和(4)依从性:接受最少一剂研究干预的登记患者的比例。
背景:已在所有站点获得机构研究伦理委员会的批准。审判结束时,结果的简单语言摘要将发布在试验网站上,并在非专业媒体上分发。我们的试验结果将发表在同行评审的科学杂志上。
背景:NCT04803747。
BACKGROUND: Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.
METHODS: A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.
BACKGROUND: Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.
BACKGROUND: NCT04803747.