Department of Anaesthesia and Critical Care, "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico," Milan, Italy.
Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
Crit Care Med. 2020 Nov;48(11):1636-1644. doi: 10.1097/CCM.0000000000004590.
Supplementation of antithrombin might decrease the amount of heparin needed to achieve a given anticoagulation target during extracorporeal membrane oxygenation. However, exogenous antithrombin itself may increase the risk of bleeding. We conceived a study to evaluate the effect of antithrombin supplementation in adult patients requiring venovenous extracorporeal membrane oxygenation for respiratory failure on heparin dose, adequacy of anticoagulation, and safety.
Prospective randomized controlled trial.
ICUs of two Italian referral extracorporeal membrane oxygenation centers.
Adult patients requiring venovenous extracorporeal membrane oxygenation for severe respiratory failure and unfractionated heparin for systemic anticoagulation.
Before extracorporeal membrane oxygenation start, patients were randomized to either receive antithrombin concentrate to maintain a plasmatic level 80-120% (treatment) or not (control) during the extracorporeal membrane oxygenation course.
The primary outcome was the total amount of heparin required to maintain activated partial thromboplastin time ratio 1.5-2. Secondary outcomes were anti-factor Xa, the incidence of hemorrhagic and thrombotic events, and the amount of blood products transfused. Twenty-four patients in the treatment group and 24 in the control group were included in the intention-to-treat analysis. Antithrombin was 109.5% (93.0-123.0%) in the treatment group and 84.0% (68.5-98.0%) in the control group (p = 0.001). Supplementation of antithrombin did not decrease heparin dose (13.5 international units/kg/hr [9.6-17.9 international units/kg/hr] vs 15.1 international units/kg/hr [10.7-18.3 international units/kg/hr] in the treatment and control group, respectively; p = 0.33) and anti-Factor Xa levels (0.4 international units/mL [0.3-0.5 international units/mL] vs 0.3 international units/mL [0.2-0.5 international units/mL] in the treatment group and control group respectively; p = 0.65). Bleeding, blood product transfusions, and thrombosis were not different in the two groups.
Antithrombin supplementation may not decrease heparin requirement nor diminish the incidence of bleeding and/or thrombosis in adult patients on venovenous extracorporeal membrane oxygenation.
在体外膜肺氧合期间，补充抗凝血酶可能会减少达到特定抗凝目标所需的肝素用量。然而，外源性抗凝血酶本身可能会增加出血的风险。我们设计了一项研究，以评估补充抗凝血酶对需要静脉-静脉体外膜肺氧合治疗呼吸衰竭的成年患者的肝素剂量、抗凝充分性和安全性的影响。
前瞻性随机对照试验。
意大利两个专门的体外膜肺氧合中心的 ICU。
需要静脉-静脉体外膜肺氧合治疗严重呼吸衰竭和普通肝素全身抗凝的成年患者。
在体外膜肺氧合开始前，患者被随机分配接受抗凝血酶浓缩物治疗，以维持体外膜肺氧合过程中血浆水平 80-120%（治疗组）或不接受（对照组）。
主要结局是维持活化部分凝血活酶时间比值 1.5-2 所需的肝素总量。次要结局是抗因子 Xa、出血和血栓形成事件的发生率以及输血量。治疗组和对照组各有 24 例患者纳入意向治疗分析。治疗组的抗凝血酶为 109.5%（93.0-123.0%），对照组为 84.0%（68.5-98.0%）（p=0.001）。补充抗凝血酶并未减少肝素剂量（治疗组 13.5 国际单位/公斤/小时[9.6-17.9 国际单位/公斤/小时]与对照组 15.1 国际单位/公斤/小时[10.7-18.3 国际单位/公斤/小时]；p=0.33）和抗因子 Xa 水平（治疗组 0.4 国际单位/毫升[0.3-0.5 国际单位/毫升]与对照组 0.3 国际单位/毫升[0.2-0.5 国际单位/毫升]；p=0.65）。两组出血、输血量和血栓形成无差异。
补充抗凝血酶可能不会减少肝素的需求，也不会降低静脉-静脉体外膜肺氧合患者出血和/或血栓形成的发生率。
