Hematology and Medical Oncology, University of Manitoba/CancerCare Manitoba, Winnipeg, Manitoba, Canada.
University of Ottawa, Ottawa, Ontario, Canada
BMJ Open. 2024 Jun 3;14(6):e084847. doi: 10.1136/bmjopen-2024-084847.
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.
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.
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.
NCT04803747.
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血液流失和红细胞（RBC）输血。虽然 TXA 在这些手术中的使用是常规的，但在输血率相当的其他手术（包括肿瘤手术）中，其疗效和安全性尚不确定。我们的主要目标是评估在接受非心脏大手术的患者中实施医院层面的常规 TXA 使用政策是否可以在不增加血栓风险的情况下减少 RBC 输血。
这是一项在加拿大 10 个地点进行的基于注册、盲法、集群交叉随机对照试验，招募了接受非心脏手术且有高输血风险的患者。这些地点以 4 周为间隔随机分为术中 TXA 或匹配安慰剂的医院政策。TXA 在皮肤切开时给予 1g，然后在皮肤闭合前再给予 1g。主要结局是（1）有效性，评估为住院期间接受 RBC 输血的患者比例；（2）安全性，评估为 90 天内诊断为静脉血栓栓塞的患者比例。次要结局包括：（1）输血：输血的 RBC 单位数量（包括医院和患者水平）；（2）安全性：住院期间诊断为心肌梗死、中风、深静脉血栓或肺栓塞；（3）临床：住院时间、重症监护病房入院、医院存活率、90 天存活率以及存活天数和住院天数至第 30 天；以及（4）依从性：接受至少一剂研究干预的入组患者比例。
所有地点均获得机构研究伦理委员会的批准。试验完成后，将在试验网站上发布结果的通俗易懂摘要，并在大众媒体上发布。我们的试验结果将发表在同行评议的科学期刊上。
NCT04803747。
