Large variation in anti-factor Xa levels with nadroparin as thromboprophylaxis in COVID-19 and non-COVID-19 critically ill patients.

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY BMC Pharmacology & Toxicology Pub Date : 2024-02-06 DOI:10.1186/s40360-024-00733-x
Monique M R de Maat, Henk J van Leeuwen, Lian Roovers, Sabine J G M Ahlers, Jolanda Lambers, Marcel M C Hovens
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Abstract

Purpose: 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).

Conclusion: 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.

Clinical trials registration: Retrospectively registered, ClinicalTrials.gov ID NTC 05926518 g, date of registration 06/01/23, unique ID 2020/1725.

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在 COVID-19 和非 COVID-19 重症患者中使用纳多肝素作为血栓预防药物时,抗因子 Xa 水平存在巨大差异。
目的:COVID-19 和非 COVID-19 重症患者接受 LMWH 纳多肝素血栓预防治疗。标准剂量是否足以使这些患者达到目标抗 FXa 水平(0.20-0.50 IU/ml)尚不清楚:本研究是一项前瞻性观察研究,在荷兰一家大型综合教学医院的重症监护室进行。重症监护室收治的 COVID-19 和非 COVID-19 患者均符合研究条件,他们均接受了预防性 LMWH 治疗,皮下注射剂量分别为 2850 IU、5700 IU 或 11400 IU。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、预设的共变量和临床数据。研究的主要目的是评估服用纳多肝素预防剂量的重症患者的抗 FXa 水平。第二个目标是研究协变量是否会影响抗 FXa 水平:共有 62 名患者参与了分析。在 COVID-19 组和非 COVID-19 组中,分别有 29 名(96%)和 12 名(38%)患者的抗 FXa 水平超过了 0.20 IU/ml。在非 COVID-19 组中,63% 的患者抗 FXA 水平低于目标范围。在调整纳多肝素剂量后,发现体重与抗 FXa 水平之间存在显著关系(p = 0.013):结论:对重症患者而言,2850 IU sc 的纳多肝素标准剂量不足以使大多数研究对象达到目标抗 FXa 水平。我们建议采用更高的标准剂量,并结合与体重相关的剂量,因为这样可以提高纳多肝素的暴露量:临床试验注册:回顾性注册,ClinicalTrials.gov ID NTC 05926518 g,注册日期 06/01/23,唯一 ID 2020/1725。
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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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