Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
BACKGROUND: Retrospectively registered, ClinicalTrials.gov ID NTC 05926518 g, date of registration 06/01/23, unique ID 2020/1725.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.
BACKGROUND: Retrospectively registered, ClinicalTrials.gov ID NTC 05926518 g, date of registration 06/01/23, unique ID 2020/1725.
摘要：
目的：重症COVID-19和非COVID-19患者接受LMWH纳曲帕林预防血栓形成。在这些组中,标准剂量是否足以达到目标抗FXa水平(0.20-0.50IU/ml)是未知的。
方法：这项研究是一项前瞻性的，在荷兰一家大型综合教学医院的ICU进行的观察性研究。入住ICU的COVID-19和非COVID-19患者接受了2850IU预防剂量的LMWH，皮下5700IU或11400IU适合该研究。给药后4小时测定抗FXa水平。相关实验室参数,从电子健康记录系统中提取预设的协变量和临床数据.主要目标是评估预防剂量的那曲帕林在危重患者中的抗FXa水平。第二个目标是调查协变量是否对抗FXa水平有影响。
结果：共62例患者纳入分析。在COVID-19组和非COVID-19组中，29例（96％）和12例（38％）患者的抗FXa水平达到0.20IU/ml以上，分别。在非COVID-19组中，63%的患者的抗FXA水平低于目标范围。当调整纳曲肝素剂量时，发现体重与抗FXa水平之间存在显着关系（p=0.013）。
结论：在大多数研究患者组中，危重患者中2850IUsc的标准纳曲肝素剂量不足以达到目标抗FXa水平。我们建议使用标准的更高剂量与体重依赖性剂量相结合，因为它可以更好地暴露于纳德罗帕林。
背景：回顾性注册，ClinicalTrials.govIDNTC05926518g,注册日期06/01/23，唯一ID2020/1725。
方法：这项研究是一项前瞻性的，在荷兰一家大型综合教学医院的ICU进行的观察性研究。入住ICU的COVID-19和非COVID-19患者接受了2850IU预防剂量的LMWH，皮下5700IU或11400IU适合该研究。给药后4小时测定抗FXa水平。相关实验室参数,从电子健康记录系统中提取预设的协变量和临床数据.主要目标是评估预防剂量的那曲帕林在危重患者中的抗FXa水平。第二个目标是调查协变量是否对抗FXa水平有影响。
结果：共62例患者纳入分析。在COVID-19组和非COVID-19组中，29例（96％）和12例（38％）患者的抗FXa水平达到0.20IU/ml以上，分别。在非COVID-19组中，63%的患者的抗FXA水平低于目标范围。当调整纳曲肝素剂量时，发现体重与抗FXa水平之间存在显着关系（p=0.013）。
结论：在大多数研究患者组中，危重患者中2850IUsc的标准纳曲肝素剂量不足以达到目标抗FXa水平。我们建议使用标准的更高剂量与体重依赖性剂量相结合，因为它可以更好地暴露于纳德罗帕林。
背景：回顾性注册，ClinicalTrials.govIDNTC05926518g,注册日期06/01/23，唯一ID2020/1725。
