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Abstract：
Objective: Although heparin is the current standard anticoagulant during venoarterial (VA) and venovenous (VV) extracorporeal membrane oxygenation (ECMO), factors including heparin-induced thrombocytopenia, heparin resistance and drug shortages necessitate alternative anticoagulants such as direct thrombin inhibitors. The aim was to characterize dosing, safety, and efficacy of bivalirudin during ECMO support. Methods: This retrospective single-center study included 24 adults on ECMO support who received ≥6 hours of bivalirudin. The primary endpoint was dose to first therapeutic activated partial thromboplastin time (aPTT). Secondary endpoints included evaluating dosing between ECMO modes, incidence of bleeding and thrombotic events, and time in therapeutic range (TTR). Results: The dose at time of first therapeutic aPTT was bivalirudin 0.05 [0.05-0.1] mg/kg/hour. Bivalirudin dosing requirements were lower in VAECMO compared to VV-ECMO patients and were not impacted by continuous venovenous hemofiltration. Time to therapeutic aPTT was 5.5 [2-13] hours for VA-ECMO and 4.5 [2-8.6] hours for VV-ECMO patients. During any mode of ECMO TTR was 58.3% [39.6-73.1]. Thrombotic events occurred in 3 (13%) patients and major bleeding occurred in 12 (50%) patients. Conclusions: Our findings demonstrated variable bivalirudin dosing requirements based on mode of ECMO and dosing modifications may not be required during CVVH. Factors including mode of ECMO, indication for bivalirudin and concomitant antiplatelet therapy may impact hematologic events. Application of this data can assist with developing a bivalirudin ECMO protocol which provides less variability in initial dosing and TTR.
摘要：
目的：尽管肝素是目前在静脉动脉（VA）和静脉静脉（VV）体外膜氧合（ECMO）过程中的标准抗凝剂，因素包括肝素诱导的血小板减少症，肝素耐药性和药物短缺需要替代抗凝剂，如直接凝血酶抑制剂。目的是表征剂量，安全,ECMO支持期间比伐卢定的疗效。方法：这项回顾性单中心研究包括24名接受ECMO支持的成年人，他们接受了≥6小时的比伐卢定。主要终点为剂量至首次治疗活化部分凝血活酶时间(aPTT)。次要终点包括评估ECMO模式之间的给药，出血和血栓事件的发生率，和治疗范围内的时间（TTR）。结果：首次治疗aPTT时的剂量为比伐卢定0.05[0.05-0.1]mg/kg/小时。与VV-ECMO患者相比，VAECMO患者的比伐卢定剂量要求较低，并且不受连续静脉静脉血液滤过的影响。VA-ECMO患者治疗aPTT的时间为5.5[2-13]小时，VV-ECMO患者为4.5[2-8.6]小时。在任何ECMO模式下，TTR为58.3%[39.6-73.1]。3例（13%）患者发生血栓事件，12例（50%）患者发生大出血。结论：我们的发现证明了基于ECMO模式的可变比伐卢定剂量要求，并且在CVVH期间可能不需要剂量修改。包括ECMO模式在内的因素，比伐卢定和联合抗血小板治疗的适应症可能会影响血液学事件.该数据的应用可以帮助开发比伐卢定ECMO方案，该方案在初始给药和TTR中提供较小的变异性。
