Babu Mittapalli J, Neema Praveen K, Reazaul Karim Habib M, Dey Samarjit, Arora Ripudaman
Anaesthesiology, Critical Care, and Pain Medicine, All India Institute of Medical Sciences, Raipur, IND.
Cardiac Anaesthesia, UN Mehta Institute of Cardiology and Research Centre, Ahmedabad, IND.
Cureus. 2021 Dec 5;13(12):e20190. doi: 10.7759/cureus.20190. eCollection 2021 Dec.
Background and aim Head and neck cancer is frequent, and surgeries pose more significant morbidity and mortality due to multitudinal causes; heavy blood loss and transfusion are among them. Tranexamic acid (TXA) is known to stabilize the micro clots hence controlling excessive blood loss. The present study aimed to compare perioperative blood loss with two different doses of TXA and placebo to find the effectiveness and optimal dose. Methods With ethical approvals and informed consent, the present prospective, randomized, double-blind, controlled study was conducted in a teaching institute from May 31, 2018, to Dec 28, 2019. Patients undergoing elective head and neck cancer (HNC) surgeries were included. Preoperative Hb < 7 gm% or > 16 gm%, known coagulopathy, anticoagulant therapy, contraindications to TXA, intraoperative torrential or blood loss due to arterial injury were excluded. Group T-1 received TXA 10mg/kg, T-II received 15 mg/kg, while the control group (Gr-C) received equal volume normal saline. Data about demography, surgical time, intraoperative and postoperative blood loss, and transfusion were collected and compared. SPSS software was used for analysis; p-value <0.05 was considered significant. Results Ninety patients were screened, 84 completed the study. All three groups were similar in demographics. The median blood loss with 25 -75 percentile in group C, T-I, and T-II groups were 762.5 (513.5-1193), 541.5 (296.5-787), and 536.0 (180.5 - 879) mL, respectively; p: 0.025. There was a significant difference between the control group and T-I (p-value: 0.0153), and control and T-II (p-value: 0.0248), but an insignificant difference between T-I and T-II (p-value: 0.706). 5 (17.85%) in each of T-I and T-II required transfusion, whereas 14 (50%) in the control group required it; p < 0.011). No major clinically significant related to study drugs were noted. Conclusion Compared to placebo (normal saline), preoperative administration of TXA in bolus significantly reduced perioperative blood losses and transfusion requirement in patients undergoing HNC surgery as estimated using the Hb-based method. A bolus dose of doses of 10mg/kg and 15 mg/kg is equally effective.
背景与目的 头颈癌较为常见，由于多种原因，手术带来的发病率和死亡率更高，大量失血和输血便是其中原因。已知氨甲环酸（TXA）可稳定微血栓，从而控制过度失血。本研究旨在比较两种不同剂量的TXA与安慰剂的围手术期失血量，以确定其有效性和最佳剂量。方法 经伦理批准并获得知情同意后，本前瞻性、随机、双盲、对照研究于2018年5月31日至2019年12月28日在一所教学机构开展。纳入接受择期头颈癌（HNC）手术的患者。排除术前血红蛋白<7g%或>16g%、已知凝血功能障碍、抗凝治疗、TXA禁忌证、术中大出血或因动脉损伤导致失血的患者。T-1组接受10mg/kg的TXA，T-II组接受15mg/kg的TXA，而对照组（Gr-C）接受等体积的生理盐水。收集并比较有关人口统计学、手术时间、术中和术后失血量及输血情况的数据。使用SPSS软件进行分析；p值<0.05被认为具有统计学意义。结果 筛查了90例患者，84例完成研究。三组在人口统计学方面相似。C组、T-I组和T-II组的中位失血量及25%-75%百分位数分别为762.5（513.5-1193）mL、541.5（296.5-787）mL和536.0（180.5-879）mL；p=0.025。对照组与T-I组之间存在显著差异（p值：0.0153），对照组与T-II组之间也存在显著差异（p值：0.0248），但T-I组与T-II组之间无显著差异（p值：0.706）。T-I组和T-II组各有5例（17.85%）需要输血，而对照组有14例（50%）需要输血；p<0.011）。未发现与研究药物相关的重大临床显著问题。结论 与安慰剂（生理盐水）相比，术前大剂量给予TXA可显著减少接受HNC手术患者的围手术期失血量和输血需求，这是基于血红蛋白的方法估算得出的。10mg/kg和15mg/kg的大剂量同样有效。
