Department of Clinical Pharmacy, Rijnstate Hospital, Arnhem, The Netherlands.
Department of Internal Medicine and Intensive Care, Rijnstate Hospital, Arnhem, The Netherlands.
BMC Pharmacol Toxicol. 2024 Feb 6;25(1):16. doi: 10.1186/s40360-024-00733-x.
Critically ill COVID-19 and non-COVID-19 patients receive thromboprophylaxis with the LMWH nadroparin. Whether a standard dosage is adequate in attaining the target anti-FXa levels (0.20-0.50 IU/ml) in these groups is unknown.
This study was a prospective, observational study in the ICU of a large general teaching hospital in the Netherlands. COVID-19 and non-COVID-19 patients admitted to the ICU who received LMWH in a prophylactic dosage of 2850 IU, 5700 IU or 11400 IU subcutaneously were eligible for the study. Anti-FXa levels were determined 4 h after administration. Relevant laboratory parameters, prespecified co-variates and clinical data were extracted from the electronic health record system. The primary goal was to evaluate anti-FXa levels in critically ill patients on a prophylactic dosage of nadroparin. The second goal was to investigate whether covariates had an influence on anti-FXa levels.
A total of 62 patients were included in the analysis. In the COVID-19 group and non-COVID-19 group, 29 (96%) and 12 patients (38%) reached anti-FXa levels above 0.20 IU/ml, respectively. In the non-COVID-19 group, 63% of the patients had anti-FXA levels below the target range. When adjusted for nadroparin dosage a significant relation was found between body weight and the anti-FXa level (p = 0.013).
A standard nadroparin dosage of 2850 IU sc in the critically ill patient is not sufficient to attain target anti-FXa levels in the majority of the studied patient group. We suggest a standard higher dosage in combination with body-weight dependent dosing as it leads to better exposure to nadroparin.
Retrospectively registered, ClinicalTrials.gov ID NTC 05926518 g, date of registration 06/01/23, unique ID 2020/1725.
危重症 COVID-19 和非 COVID-19 患者均接受低分子肝素那屈肝素进行血栓预防。目前尚不清楚在这两组人群中,标准剂量是否足以达到目标抗 FXa 水平(0.20-0.50 IU/ml)。
本研究是荷兰一家大型综合教学医院 ICU 进行的一项前瞻性观察性研究。纳入接受皮下给予 2850 IU、5700 IU 或 11400 IU 预防性剂量 LMWH 的 ICU 收治的 COVID-19 和非 COVID-19 患者。给药后 4 小时测定抗 FXa 水平。从电子健康记录系统中提取相关实验室参数、预设协变量和临床数据。主要目标是评估接受预防性剂量那屈肝素的危重症患者的抗 FXa 水平。次要目标是研究协变量是否对抗 FXa 水平有影响。
共纳入 62 例患者进行分析。在 COVID-19 组和非 COVID-19 组中,分别有 29 例(96%)和 12 例(38%)患者的抗 FXa 水平超过 0.20 IU/ml。在非 COVID-19 组中,有 63%的患者抗 FXA 水平低于目标范围。在校正那屈肝素剂量后,体重与抗 FXa 水平之间存在显著关系(p=0.013)。
在大多数研究患者群体中,危重症患者给予标准剂量 2850 IU 皮下注射那屈肝素不能达到目标抗 FXa 水平。我们建议使用标准较高的剂量,结合体重依赖性剂量,因为这可以使那屈肝素更好地暴露。
回顾性注册,ClinicalTrials.gov ID NTC 05926518,注册日期 2023 年 6 月 1 日,唯一识别码 2020/1725。