自由基膀胱切除术期间的曲霉素：一项随机临床试验

在癌症手术中，需要开放式膀胱切除术的患者患红细胞（RBC）输血的风险最高。预防性曲霉素（TXA）减少了心脏和骨科手术期间的失血，并且在自由基膀胱切除术期间可能会观察到类似的TXA作用。确定在切口前进行的TXA是否在切开前进行了TXA，并在自由基cytrosy的持续时间内降低了30天的自由基胞置次数的次数。 （TACT）是一项双盲，安慰剂对照的随机临床试验，在2013年6月至2021年1月之间入学。这项多中心试验是在10个学术中心进行的。如果患者有计划开放的自由基膀胱切除术以治疗膀胱癌，则连续的患者样本符合条件。在切口之前，干预臂中的患者接受了静脉内TXA的负载剂量，10 mg/kg，然后每小时每小时5 mg/kg维持手术。在对照组中，患者接受了无法区分的匹配安慰剂。主要结果是在手术后30天内收到RBC输血。总共评估了386例患者的资格，而33例未符合资格。在353名随机患者（中位[IQR]年龄，69 [62-75]年； 263名男性[74.5％]）中，有344例被包括在意向性治疗分析中。 TXA组的173例患者中有64例中有64例（37.0％），安慰剂组中有64例（相对风险，0.99; 95％CI，0.83-1.18）中有64例（37.4％）中的64例中，RBC输血最多30天。 TXA组与安慰剂组之间的次级结果没有差异，包括均方根（SD）RBC单位数量（0.9 [1.5] U vs 1.1 [1.8] U; P = .43），估计失血量，927 [733] ML vs 963 ML vs 963 [624] ML; P = .52），Intrafient of Antraivative ofaivitival in Intravient of A.52，Intrafiant（28）[28.28 3.28 3. vs 24.0％[171中的41个]；两组之间，无连接相关的不良事件相似。这项随机临床试验的分辨表明，TXA并未减少接受开放的自由基膀胱切除术的膀胱癌的患者的输血。基于此试验，不建议在开放自由基膀胱切除术期间常规使用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.