全切除术中氨略酸：一项随机临床试验

在癌症手术中，接受开放性全膀胱切除术的患者输血红细胞（RBC）的风险最高。预防性应用氨略酸（TXA）已被证明可以减少心脏手术和骨科手术中的出血，可能在全膀胱切除术中也会观察到类似的效果。本研究旨在确定在切口前及全膀胱切除术期间给予TXA是否能减少患者术后30天内接受的RBC输血次数。全膀胱切除术期间的氨略酸治疗（TACT）是一项双盲、安慰剂对照、随机临床试验，于2013年6月至2021年1月期间招募。该多中心试验在10个学术中心进行。符合条件的患者为计划接受开放性膀胱癌切除术的患者。手术前，干预组患者接受静脉注射氨略酸负载剂，剂量为10 mg/kg，术中维持输注为5 mg/kg每小时。对照组患者接受外观相同的安慰剂。主要结局指标是术后30天内是否接受RBC输血。共评估386名患者的资格，其中33名不符合资格。随机分组的353名患者（中位年龄[四分位数]为69岁[62-75]岁；男性263名[74.5%]）中，有344名被纳入意向治疗分析。在术后30天内，氨略酸组有173名患者中64名（37.0%）接受了RBC输血，安慰剂组中171名患者中64名（37.4%）接受了输血（相对危险度0.99；95%置信区间0.83-1.18）。氨略酸组与安慰剂组在次要结局方面无显著差异，包括平均（标准差）输血单位数（0.9 [1.5] U对比1.1 [1.8] U；P = .43）、估计出血量（927 [733] mL对比963 [624] mL；P = .52）、术中输血比例（28.3%[49/173]对比24.0%[41/171]；P = .08）或静脉血栓栓塞事件（3.5%[6/173]对比2.9%[5/171]；P = .57）。非输血相关不良事件在两组中也相似。该随机临床试验结果显示，氨略酸在接受开放性膀胱切除术治疗膀胱癌的患者中未能降低出血需求。基于此试验，不建议在此类手术中常规使用氨略酸。临床试验注册号：NCT01869413。

Among cancer surgeries, patients requiring open radical cystectomy have the highest risk of red blood cell (RBC) transfusion. Prophylactic tranexamic acid (TXA) reduces blood loss during cardiac and orthopedic surgery, and it is possible that similar effects of TXA would be observed during radical cystectomy.To determine whether TXA, administered before incision and for the duration of radical cystectomy, reduced the number of RBC transfusions received by patients up to 30 days after surgery.The Tranexamic Acid During Cystectomy Trial (TACT) was a double-blind, placebo-controlled, randomized clinical trial with enrollment between June 2013 and January 2021. This multicenter trial was conducted in 10 academic centers. A consecutive sample of patients was eligible if the patients had a planned open radical cystectomy for the treatment of bladder cancer.Before incision, patients in the intervention arm received a loading dose of intravenous TXA, 10 mg/kg, followed by a maintenance infusion of 5 mg/kg per hour for the duration of the surgery. In the control arm, patients received indistinguishable matching placebo.The primary outcome was receipt of RBC transfusion up to 30 days after surgery.A total of 386 patients were assessed for eligibility, and 33 did not meet eligibility. Of 353 randomized patients (median [IQR] age, 69 [62-75] years; 263 male [74.5%]), 344 were included in the intention-to-treat analysis. RBC transfusion up to 30 days occurred in 64 of 173 patients (37.0%) in the TXA group and 64 of 171 patients (37.4%) in the placebo group (relative risk, 0.99; 95% CI, 0.83-1.18). There were no differences in secondary outcomes among the TXA group vs placebo group including mean (SD) number of RBC units transfused (0.9 [1.5] U vs 1.1 [1.8] U; P = .43), estimated blood loss (927 [733] mL vs 963 [624] mL; P = .52), intraoperative transfusion (28.3% [49 of 173] vs 24.0% [41 of 171]; P = .08), or venous thromboembolic events (3.5% [6 of 173] vs 2.9% [5 of 171]; P = .57). Non-transfusion-related adverse events were similar between groups.Results of this randomized clinical trial reveal that TXA did not reduce blood transfusion in patients undergoing open radical cystectomy for bladder cancer. Based on this trial, routine use of TXA during open radical cystectomy is not recommended.ClinicalTrials.gov Identifier: NCT01869413.