Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
BMJ Open. 2022 Feb 24;12(2):e058850. doi: 10.1136/bmjopen-2021-058850.
Despite use of operative and non-operative interventions to reduce blood loss during liver resection, 20%-40% of patients receive a perioperative blood transfusion. Extensive intraoperative blood loss is a major risk factor for postoperative morbidity and mortality and receipt of blood transfusion is associated with serious risks including an association with long-term cancer recurrence and overall survival. In addition, blood products are scarce and associated with appreciable expense; decreasing blood transfusion requirements would therefore have health system benefits. Tranexamic acid (TXA), an antifibrinolytic, has been shown to reduce the probability of receiving a blood transfusion by one-third for patients undergoing cardiac or orthopaedic surgery. However, its applicability in liver resection has not been widely researched.
This protocol describes a prospective, blinded, randomised controlled trial being conducted at 10 sites in Canada and 1 in the USA. 1230 eligible and consenting participants will be randomised to one of two parallel groups: experimental (2 g of intravenous TXA) or placebo (saline) administered intraoperatively. The primary endpoint is receipt of blood transfusion within 7 days of surgery. Secondary outcomes include blood loss, postoperative complications, quality of life and 5-year disease-free and overall survival.
This trial has been approved by the research ethics boards at participating centres and Health Canada (parent control number 177992) and is currently enrolling participants. All participants will provide written informed consent. Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov.
NCT02261415.
尽管在肝切除术中采用了手术和非手术干预措施来减少失血，但仍有 20%-40%的患者需要接受围手术期输血。术中大量失血是术后发病率和死亡率的主要危险因素，输血与严重风险相关，包括与长期癌症复发和总体生存率相关。此外，血液制品稀缺且费用高昂；因此，减少输血需求将对卫生系统有益。氨甲环酸（TXA）是一种抗纤维蛋白溶解剂，已被证明可使接受心脏或骨科手术的患者输血的可能性降低三分之一。然而，它在肝切除术中的适用性尚未得到广泛研究。
本方案描述了一项正在加拿大的 10 个地点和美国的 1 个地点进行的前瞻性、双盲、随机对照试验。将有 1230 名符合条件并同意参加的参与者随机分为两组：实验组（静脉注射 2 g TXA）或安慰剂（生理盐水）组，术中给药。主要终点是术后 7 天内输血。次要结局包括失血、术后并发症、生活质量以及 5 年无病生存率和总生存率。
该试验已获得参与中心和加拿大卫生部（母体对照号 177992）的研究伦理委员会的批准，目前正在招募参与者。所有参与者都将提供书面知情同意书。结果将通过当地和国际会议、演讲、出版物和 ClinicalTrials.gov 广泛传播。
NCT02261415。
