Department of Orthopaedic Surgery, Scripps Clinic, La Jolla, CA, USA.
Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla, CA, USA.
Clin Orthop Relat Res. 2022 Apr 1;480(4):702-711. doi: 10.1097/CORR.0000000000002037.
Tranexamic acid (TXA) is often used to prevent excessive blood loss during bilateral TKA. Although it diminishes blood loss, TXA may have a potentially elevated thrombogenic risk with extra, unnecessary doses of TXA in this high-risk population. To date, the most efficacious dosing protocol in this setting has not yet been ascertained.
QUESTIONS/PURPOSES: We compared one versus two doses of intravenous TXA in the setting of same-day bilateral TKA in terms of (1) perioperative blood loss that occurred during the hospital stay, (2) transfusion usage during the hospital stay, and (3) major complications occurring within 30 days of surgery.
Between August 2013 and October 2016, 309 patients underwent simultaneous bilateral TKA performed by one of five attending surgeons. During that time, indications for same-day bilateral TKA included bilateral knee pathology in which each knee was independently indicated for TKA and the patient preferred bilateral simultaneous TKAs versus staged bilateral surgeries. Patients who had cardiac disease or an American Society for Anesthesiologists physical classification score of greater than 2 were not generally indicated for bilateral simultaneous TKAs. After preoperative clearance from the primary physician and/or specialists as necessary, the decision for bilateral TKA was at the judgment of the operating surgeons. Input from anesthesia occurred at the time of the surgery as the procedure was performed in a sequential fashion allowing for the surgery to be restrained to a single limb if anesthesia identified concerns at the completion of the first TKA. The current retrospective, comparative series compared generally sequential groups in terms of TXA usage. Between August 2013 and July 2015, we used two TXA doses. Patients received 1 g of intravenous TXA as a bolus immediately after the last tourniquet release and were given a 1-g intravenous bolus 6 hours after the initial dose. A total of 167 patients were treated with this approach, of whom 96% (161) are fully analyzed here. Between August 2015 and October 2016, our approach changed to a single TXA dose. The dosing regimen change occurred as a group decision for change of practice and occurred mid-year to coincide with the fellowship year cycle. Patients received a 1-g bolus of intravenous TXA immediately after the final tourniquet release. A total of 105 patients were treated with this approach, of whom 89% (93) are fully analyzed here. An additional 37 patients were excluded because they did not receive any TXA because of a medical contraindication such as history of venous thromboembolism, history of thrombotic stroke, cardiac stent in the past 2 years, atrial fibrillation, or long-term anticoagulation therapy. We compared patients who received one versus two doses in terms of blood loss, transfusion usage, and 30-day major complications. The mean age was 65 years for patients receiving one dose and 67 years for patients receiving two doses (p = 0.17). The one-dose group comprised 67% (62 of 93) women and the two-dose group comprised 61% (98 of 161) women (p = 0.36). Blood loss was defined as change in the hemoglobin level (the last recorded value before discharge subtracted from the preoperative value). During the study period, the decision to transfuse was based on a hemoglobin level less than 8.0 g/dL or at higher levels for symptomatic patients, patients with cardiac disease, or at the discretion of the attending surgeon. We defined complications as major medical events that included cerebrovascular accidents, myocardial infarction, deep vein thrombosis, and pulmonary embolism.
With the numbers available, there was no difference in blood loss between patients treated with one and those treated with two doses of TXA (mean hemoglobin decrease -3.5 ± 1.2 g/dL versus -3.5 ± 1.0 g/dL, respectively; mean difference 0.03 g/dL [95% CI -0.2 to 0.3 g/dL]; p = 0.80). No patient in either group received a transfusion. There was no difference in the proportion of patients in either group who experienced a cerebrovascular accident (0% [0 of 93] versus 1% [1 of 161]; p > 0.99), deep vein thrombosis (1% [1 of 93] versus 0% [0 of 161]; p = 0.37), or pulmonary embolism (1% [1 of 93] versus 1% [1 of 161]; p > 0.99). No patient in either the one-dose or two-dose TXA groups experienced a myocardial infarction.
The findings of this study suggest that a single dose of intravenous TXA may be adequate to control excessive blood loss and reduce blood transfusion in simultaneous bilateral TKA. Despite its short half-life, TXA still appears to be effective in this demanding procedure without requiring prolonged plasma concentrations obtained from multiple doses. Additional high-quality studies are still needed to determine the most appropriate dosing regimen.
Level III, therapeutic study.
氨甲环酸(TXA)常用于预防双侧全膝关节置换术(TKA)过程中的大量失血。尽管它可以减少出血量,但在这种高风险人群中,额外、不必要剂量的 TXA 可能会增加潜在的血栓形成风险。迄今为止,尚未确定该情况下最有效的给药方案。
问题/目的:我们比较了双侧 TKA 患者在同一天接受一剂与两剂静脉 TXA 的情况下,(1)住院期间发生的围手术期失血,(2)住院期间的输血使用情况,以及(3)术后 30 天内发生的主要并发症。
2013 年 8 月至 2016 年 10 月,有 309 例患者由 5 位主治医生中的一位进行了同时双侧 TKA。在此期间,双侧 TKA 的适应证包括膝关节病变,其中每个膝关节都需要单独进行 TKA,并且患者更倾向于双侧同时进行 TKA 而不是分期双侧手术。有心脏病或美国麻醉医师协会(ASA)身体状况评分大于 2 的患者一般不适合双侧同时进行 TKA。在主要医生术前明确(如有必要)和/或专家同意后,由手术医生判断是否进行双侧 TKA。在手术过程中,麻醉师会提供输入意见,手术以顺序方式进行,以便在第一次 TKA 完成后,如果麻醉师发现任何问题,可以限制在一条肢体上进行手术。目前的回顾性比较系列研究根据 TXA 的使用情况比较了通常顺序进行的组。2013 年 8 月至 2015 年 7 月,我们使用了两剂 TXA。患者在最后一次止血带释放后立即接受 1 g 静脉 TXA 推注,并在初始剂量后 6 小时接受 1 g 静脉推注。共有 167 例患者接受了这种治疗方法,其中 96%(161 例)在这里进行了全面分析。2015 年 8 月至 2016 年 10 月,我们的治疗方法改为一剂 TXA。这种方案的改变是作为改变实践的集体决定,发生在年中,与研究员年周期相吻合。患者在最后一次止血带释放后立即接受 1 g 静脉 TXA 推注。共有 105 例患者接受了这种治疗方法,其中 89%(93 例)在这里进行了全面分析。另有 37 例患者因静脉血栓栓塞、血栓性中风、过去 2 年内心脏支架、心房颤动或长期抗凝治疗等医学禁忌而未接受任何 TXA,被排除在外。我们比较了接受一剂与两剂的患者的失血、输血使用情况和术后 30 天的主要并发症。接受一剂的患者平均年龄为 65 岁,接受两剂的患者平均年龄为 67 岁(p = 0.17)。一剂组中 67%(93 例中的 62 例)为女性,两剂组中 61%(161 例中的 98 例)为女性(p = 0.36)。失血量定义为血红蛋白水平的变化(出院前最后一次记录值减去术前值)。在研究期间,输血的决定基于血红蛋白水平低于 8.0 g/dL 或有症状的患者、有心脏病的患者或主治医生的酌情决定。我们将并发症定义为包括中风、心肌梗死、深静脉血栓形成和肺栓塞在内的重大医疗事件。
根据现有数据,接受一剂和两剂 TXA 的患者之间的失血量没有差异(平均血红蛋白下降-3.5 ± 1.2 g/dL 与-3.5 ± 1.0 g/dL,平均差异 0.03 g/dL [95%CI -0.2 至 0.3 g/dL];p = 0.80)。两组均无患者输血。两组中发生中风(0%[0 例/93 例]与 1%[1 例/161 例];p > 0.99)、深静脉血栓形成(1%[1 例/93 例]与 0%[0 例/161 例];p = 0.37)或肺栓塞(1%[1 例/93 例]与 1%[1 例/161 例];p > 0.99)的患者比例无差异。两剂 TXA 组和一剂 TXA 组均无患者发生心肌梗死。
本研究结果表明,单侧静脉 TXA 一剂可能足以控制双侧 TKA 同时发生的大量失血并减少输血需求。尽管其半衰期较短,但 TXA 似乎仍然在这种高要求的手术中有效,而无需通过多次剂量获得延长的血浆浓度。仍需要更多高质量的研究来确定最合适的给药方案。
III 级,治疗性研究。