在癌症手术中，需要开放根治性膀胱切除术的患者输红细胞（RBC）的风险最高。预防性氨甲环酸 (TXA) 可减少心脏和骨科手术期间的失血，并且在根治性膀胱切除术期间可能会观察到 TXA 的类似效果。为了确定在切口前和根治性膀胱切除术期间施用 TXA 是否可以减少数量手术后 30 天内患者接受的红细胞输血量。膀胱切除术期间的氨甲环酸试验 (TACT) 是一项双盲、安慰剂对照、随机临床试验，入组时间为 2013 年 6 月至 2021 年 1 月。这项多中心试验于10个学术中心。如果患者计划进行开放性根治性膀胱切除术来治疗膀胱癌，则连续的患者样本符合资格。在切开手术之前，干预组中的患者接受静脉 TXA 负荷剂量 10 mg/kg，随后维持输注手术期间每小时 5 毫克/公斤。在对照组中，患者接受了无法区分的匹配安慰剂。主要结局是术后 30 天接受红细胞输注。总共 386 名患者接受了资格评估，其中 33 名不符合资格。在 353 名随机患者（中位 [IQR] 年龄，69 [62-75] 岁；263 名男性 [74.5%]）中，有 344 名患者被纳入意向治疗分析。 TXA 组 173 名患者中有 64 名 (37.0%) 进行了长达 30 天的红细胞输注，安慰剂组 171 名患者中有 64 名 (37.4%) 进行了长达 30 天的红细胞输注（相对风险，0.99；95% CI，0.83-1.18）。 TXA 组与安慰剂组的次要结果没有差异，包括输注红细胞单位的平均 (SD) 数（0.9 [1.5] U vs 1.1 [1.8] U；P = .43）、估计失血量（927 [733] ] mL vs 963 [624] mL；P = .52）、术中输血（28.3% [173 中的 49] vs 24.0% [171 中的 41]；P = .08）或静脉血栓栓塞事件（3.5% [173 中的 6]） 173] vs 2.9% [171 中的 5]；P = .57)。各组之间非输血相关的不良事件相似。这项随机临床试验的结果表明，TXA 并没有减少接受膀胱癌开放根治性膀胱切除术的患者的输血量。根据该试验，不建议在开放根治性膀胱切除术中常规使用 TXA。ClinicalTrials.gov 标识符：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.