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首页> 外文期刊>Critical care : >A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal
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A French multicenter randomised trial comparing two dose-regimens of prothrombin complex concentrates in urgent anticoagulation reversal

机译：一项法国多中心随机试验，比较了两种凝血酶原复合物浓缩剂在紧急抗凝逆转中的剂量方案

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IntroductionProthrombin complex concentrates (PCC) are haemostatic blood preparations indicated for urgent anticoagulation reversal, though the optimal dose for effective reversal is still under debate. The latest generation of PCCs include four coagulation factors, the so-called 4-factor PCC. The aim of this study was to compare the efficacy and safety of two doses, 25 and 40 IU/kg, of 4-factor PCC in vitamin K antagonist (VKA) associated intracranial haemorrhage.MethodsWe performed a phase III, prospective, randomised, open-label study including patients with objectively diagnosed VKA-associated intracranial haemorrhage between November 2008 and April 2011 in 22 centres in France. Patients were randomised to receive 25 or 40 IU/kg of 4-factor PCC. The primary endpoint was the international normalised ratio (INR) 10 minutes after the end of 4-factor PCC infusion. Secondary endpoints were changes in coagulation factors, global clinical outcomes and incidence of adverse events (AEs).ResultsA total of 59 patients were randomised: 29 in the 25 IU/kg and 30 in the 40 IU/kg group. Baseline demographics and clinical characteristics were comparable between the groups. The mean INR was significantly reduced to 1.2 - and ≤1.5 in all patients of both groups - 10 minutes after 4-factor PCC infusion. The INR in the 40 IU/kg group was significantly lower than in the 25 IU/kg group 10 minutes (P = 0.001), 1 hour (P = 0.001) and 3 hours (P = 0.02) after infusion. The 40 IU/kg dose was also effective in replacing coagulation factors such as PT (P = 0.038), FII (P = 0.001), FX (P <0.001), protein C (P = 0.002) and protein S (0.043), 10 minutes after infusion. However, no differences were found in haematoma volume or global clinical outcomes between the groups. Incidence of death and thrombotic events was similar between the groups.ConclusionsRapid infusion of both doses of 4-factor PCC achieved an INR of 1.5 or less in all patients with a lower INR observed in the 40 IU/kg group. No safety concerns were raised by the 40 IU/kg dose. Further trials are needed to evaluate the impact of the high dose of 4-factor PCC on functional outcomes and mortality.Trial registrationEudra CT number 2007-000602-73.
机译：简介凝血酶原复合浓缩物（PCC）是止血血液制剂，可用于紧急抗凝逆转，尽管有效逆转的最佳剂量仍存在争议。最新一代的PCC包括四个凝血因子，即所谓的4因子PCC。这项研究的目的是比较两种剂量的25和40 IU / kg的4因子PCC在维生素K拮抗剂（VKA）相关的颅内出血中的疗效和安全性。方法我们进行了III期，前瞻性，随机，开放-标签研究，包括在2008年11月至2011年4月之间在法国的22个中心客观诊断为VKA的颅内出血患者。患者被随机分配接受25或40 IU / kg的4因子PCC。主要终点是四因子PCC输注结束后10分钟的国际标准化比率（INR）。次要终点是凝血因子，总体临床结局和不良事件（AE）发生率的变化。结果共有59例患者被随机分组​​：25 IU / kg组29例，40 IU / kg组30例。两组之间的基线人口统计学和临床​​特征相当。四因子PCC输注后10分钟，两组所有患者的平均INR均显着降低至1.2-≤1.5。输注后10分钟（P = 0.001），1小时（P = 0.001）和3小时（P = 0.02），40 IU / kg组的INR显着低于25 IU / kg组。 40 IU / kg剂量还可以有效替代凝血因子，例如PT（P = 0.038），FII（P = 0.001），FX（P <0.001），C蛋白（P = 0.002）和S蛋白（0.043），输液后10分钟。但是，两组之间在血肿量或整体临床结局方面未发现差异。各组之间的死亡和血栓形成事件的发生率相似。结论快速输注两种剂量的4因子PCC在所有40 IU / kg组中均观察到较低的INR，所有患者的INR均为1.5或更低。 40 IU / kg剂量未引起安全隐患。需要进一步的试验以评估高剂量的4因子PCC对功能结局和死亡率的影响。试验注册Eudra CT编号2007-000602-73。

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