Low-Dose Versus Therapeutic Anticoagulation in Patients on Extracorporeal Membrane Oxygenation: A Pilot Randomized Trial
Low-Dose Versus Therapeutic Anticoagulation in Patients on Extracorporeal Membrane Oxygenation: A Pilot Randomized Trial
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DOI：
10.1097/ccm.0000000000003780
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发表时间：
2019-07-01
影响因子：
8.8
通讯作者：
Cooper, D. James
中科院分区：
文献类型：
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作者：
Aubron, Cecile;McQuilten, Zoe;Cooper, D. James
目的：确定接受体外膜肺氧合的患者随机接受治疗方案或低剂量抗凝方案是否会导致活化部分凝血活酶时间和抗 Xa 抗体的差异。设计：随机、对照、非盲研究。地点：两所大学医院的两个 ICU。患者：入住 ICU 的患者，需要体外膜氧合（静脉或静脉动脉）且既往没有抗凝治疗指征。干预措施：使用肝素进行治疗性抗凝（目标活化部分凝血活酶时间在 50 至 70 秒之间）或较低剂量肝素（高达 12,000 U/24 小时，目标活化部分凝血活酶时间 < 45 秒）。测量和主要结果：32 名患者被随机分为两个研究组，这两个研究组在人口统计学和体外膜氧合特征方面没有显着差异。每日几何平均肝素剂量（11,742 U [95% CI, 8,601-16,031 U] vs 20,710 U [95% CI, 15,343-27,954 U]；p = 0.004）、每日几何平均活化部分凝血活酶时间（48.1 s [95% CI, 43.5-53.2]）存在显着差异s] vs 55.5 s [95% CI，50.4-61.2 s]；p = 0.04），每日几何平均抗 Xa（0.11 国际单位/mL [95% CI，0.07-0.18] vs 0.27 [95% CI，0.17-0.42]；p = 0.01）。当仅考虑静脉体外膜氧合事件时，我们发现了类似的结果；然而，当仅考虑静脉动脉体外膜氧合发作时，组间每日几何平均活化部分凝血活酶时间没有差异。结论：将体外膜肺氧合患者分配至两种不同的抗凝方案导致组间平均每日活化部分凝血活酶时间和抗 Xa 水平存在显着差异。当考虑亚组分析时，这些结果在接受静脉体外膜氧合的患者中是一致的。我们的结果支持对接受静脉体外膜氧合的患者进行更大规模试验以比较不同抗凝方案的可行性；然而，这项研究并没有为接受体外膜肺氧合的患者提供最佳抗凝方案的证据。
Objectives: To determine whether randomization of patients undergoing extracorporeal membrane oxygenation to either therapeutic or a low-dose anticoagulation protocol results in a difference in activated partial thromboplastin time and anti-Xa. Design: Randomized, controlled, unblinded study. Setting: Two ICUs of two university hospitals. Patients: Patients admitted to the ICU, who required extracorporeal membrane oxygenation (venovenous or venoarterial) and who did not have a preexisting indication for therapeutic anticoagulation. Interventions: Therapeutic anticoagulation with heparin (target activated partial thromboplastin time between 50 and 70 s) or lower dose heparin (up to 12,000 U/24 hr aiming for activated partial thromboplastin time < 45 s). Measurements and Main Results: Thirty-two patients were randomized into two study groups that were not significantly different in demographics and extracorporeal membrane oxygenation characteristics. There was a significant difference in the daily geometric mean heparin dose (11,742 U [95% CI, 8,601-16,031 U] vs 20,710 U [95% CI, 15,343-27,954 U]; p = 0.004), daily geometric mean activated partial thromboplastin time (48.1 s [95% CI, 43.5-53.2 s] vs 55.5 s [95% CI, 50.4-61.2 s]; p = 0.04), and daily geometric mean anti-Xa (0.11 international units/mL [95% CI, 0.07-0.18] vs 0.27 [95% CI, 0.17-0.42]; p = 0.01). We found similar results when considering only venovenous extracorporeal membrane oxygenation episodes; however, no difference in daily geometric mean activated partial thromboplastin time between groups when considering only venoarterial extracorporeal membrane oxygenation episodes. Conclusions: Allocating patients on extracorporeal membrane oxygenation to two different anticoagulation protocols led to a significant difference in mean daily activated partial thromboplastin time and anti-Xa levels between groups. When considering subgroups analyses, these results were consistent in patients on venovenous extracorporeal membrane oxygenation. Our results support the feasibility of a larger trial in patients undergoing venovenous extracorporeal membrane oxygenation to compare different anticoagulation protocols; however, this study does not provide evidence on the optimal anticoagulation protocol for patients undergoing extracorporeal membrane oxygenation.