ImportanceAmong 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.ObjectiveTo 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.Design, Setting, and ParticipantsThe 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.InterventionBefore 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.Main Outcomes and MeasuresThe primary outcome was receipt of RBC transfusion up to 30 days after surgery.ResultsA 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.Conclusions and RelevanceResults 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.Trial RegistrationClinicalTrials.gov Identifier: NCT01869413

中文翻译：

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根治性膀胱切除术中的氨甲环酸


重要性在癌症手术中，需要开放根治性膀胱切除术的患者输注红细胞 （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中可能会观察到 TXA 的类似效果。目的确定切开前和根治性膀胱切除术期间给予 TXA 是否减少了患者术后 30 天内接受的红细胞输注次数。设计、设置和参与者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。这项多中心试验在 10 个学术中心进行。如果患者计划进行开放根治性膀胱切除术以治疗膀胱癌，则连续的患者样本符合条件。干预 切开前，干预组患者接受负荷剂量的静脉注射 TXA，10 mg/kg，然后在手术期间以每小时 5 mg/kg 的维持输注。在对照组中，患者接受无法区分的匹配安慰剂。主要结局和测量主要结局是手术后 30 天内接受红细胞输注。结果共有 386 例患者接受了资格评估，33 例不符合资格。在 353 名随机患者 （中位 [IQR] 年龄，69 [62-75] 岁;263 名男性 [74.5%]）中，344 名被纳入意向治疗分析。TXA 组 173 例患者中有 64 例 （37.0%） 发生长达 30 天的红细胞输注，安慰剂组 171 例患者中有 64 例 （37.4%） 发生 （相对风险，0.99;95% CI，0.83-1.18）。 TXA 组与安慰剂组的次要结局没有差异，包括输注红细胞单位的平均 （SD） 数量 （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 例中的 49 例] 对 24.0% [171 例中的 41 例];P = .08），或静脉血栓栓塞事件 （3.5% [6/173] 对 2.9% [5/171];P = .57）。两组间非输血相关不良事件相似。结论和相关性这项随机临床试验的结果显示，TXA 并没有减少因膀胱癌而接受开放根治性膀胱切除术的患者的输血。根据该试验，不建议在开放根治性膀胱切除术期间常规使用 TXA。试验注册临床试验。gov 标识符： NCT01869413