BACKGROUND Thromboprophylaxis dosing strategies using enoxaparin in elderly patients with renal disease are limited, while dose adjustments or monitoring of anti-Xa levels are recommended. We sought to evaluate the efficacy and safety of enoxaparin 20 mg versus 30 mg subcutaneously daily by comparing anti-Xa levels, thrombosis and bleeding. METHODS We conducted a prospective, single-blinded, single-center randomized clinical trial including non-surgical patients, 70 years of age or older, with renal disease requiring thromboprophylaxis. Patients were randomized to receive either 20 mg or 30 mg of enoxaparin. The primary endpoint was peak anti-Xa levels on day 3. Secondary endpoints included trough anti-Xa levels on day 3, achievement of within range prophylactic target peak anti-Xa levels and the occurrence of hemorrhage, thrombosis, thrombocytopenia or hyperkalemia during hospitalization. RESULTS Thirty-two patients were recruited and sixteen patients were randomized to each arm. Mean peak anti-Xa level was significantly higher in 30 mg arm (n = 13) compared to the 20 mg arm (n = 11) 0.26 ± 0.11, 95%CI (0.18-0.34), versus 0.14 ± 0.09, 95CI (0.08-0.19) UI/ml, respectively; p = 0.004. Mean trough anti-Xa level was higher in 30 mg arm (n = 10) compared to the 20 mg arm (n = 16), 0.06 ± 0.03, 95CI (0.04-0.08) versus 0.03 ± 0.03, 95CI (0.01-0.05) UI/ml, respectively; p = 0.044. Bleeding events reported in the 30 mg arm were one retroperitoneal bleed requiring multiple transfusions, and in the 20 mg arm one hematuria. No thrombotic events were reported. CONCLUSION Peak anti-Xa levels provided by enoxaparin 20 mg were lower than the desired range for thromboprophylaxis in comparison to enoxaparin 30 mg. TRIAL REGISTRATION The trial was retrospectively registered on ClinicalTrials.gov identifier: NCT03158792 . Registered: May 18, 2017.

中文翻译：

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在非手术性肾功能不全老年患者中评估依诺肝素的预防剂量。

背景技术在老年肾病患者中使用依诺肝素预防血栓的剂量策略是有限的，同时建议调整剂量或监测抗Xa的水平。我们试图通过比较抗Xa水平，血栓形成和出血来评估依诺肝素20 mg和每日30 mg皮下注射的疗效和安全性。方法我们进行了一项前瞻性，单盲，单中心随机临床试验，该试验包括70岁以上的非手术性肾病患者，需要进行血栓预防。患者被随机分配接受20 mg或30 mg依诺肝素。主要终点为第3天的抗Xa高峰水平。次要终点为第3天的低谷抗Xa水平，预防范围内的目标目标抗Xa峰值水平以及出血，血栓形成，住院期间出现血小板减少症或高钾血症。结果招募了32例患者，每组随机分配了16例患者。30 mg组（n = 13）的平均平均抗Xa水平显着高于20 mg组（n = 11）0.26±0.11，95％CI（0.18-0.34），而0.14±0.09，95CI（0.08） -0.19）UI / ml；p ＝ 0.004。30 mg组（n = 10）的平均谷抗Xa水平高于20 mg组（n = 16）的0.06±0.03，95CI（0.04-0.08）vs 0.03±0.03，95CI（0.01-0.05） UI / ml p ＝ 0.044。据报道，在30毫克组的出血事件是一次腹膜后出血，需要多次输血，而在20毫克组的出血是一次血尿。没有血栓事件的报道。结论与30 mg依诺肝素相比，依诺肝素20 mg提供的抗Xa峰值水平低于血栓预防的所需范围。试验注册该试验已在ClinicalTrials.gov标识符NCT03158792上进行了回顾性注册。注册于：2017年5月18日。