Enoxaparin for VTE thromboprophylaxis during inpatient rehabilitation care: assessment of the standard fixed dosing regimen

Amir Haim, Orli Avnery, Deborah Rubin-Asher, Hagay Amir, Kaifa Hashem, Harel Ben Zvi, Motti Ratmansky
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Abstract

We aimed to examine the efficiency of fixed daily dose enoxaparin (40 mg) thromboprophylaxis strategy for patients undergoing inpatient rehabilitation. This was an observational, prospective, cohort study that included 63 hospitalized patients undergoing rehabilitative treatment following sub-acute ischemic stroke (SAIS) or spinal cord injury (SCI), with an indication for thromboprophylaxis. Anti-Xa level measured three hours post-drug administration (following three consecutive days of enoxaparin treatment or more) was utilised to assess in vivo enoxaparin activity. An anti-Xa level between 0.2-0.5 U/ml was considered evidence of effective antithrombotic activity. We found sub-prophylactic levels of anti-Xa (<0.2 U/ml) in 19% (12/63). Results were within the recommended prophylactic range (0.2-0.5 U/ml) in 73% (46/63) and were supra-prophylactic (>0.5 U/ml) in 7.9% (5/63) of patients. Anti-Xa levels were found to inversely correlate with patients’ weight and renal function as defined by creatinine clearance (CrCl) (p<0.05). Our study confirmed that a one-size-fits-all approach for venous thromboembolism (VTE) prophylaxis may be inadequate for rehabilitation patient populations. The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. This study suggests that anti-Xa studies and prophylactic enoxaparin dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function. No. NCT103593291, registered August 2018. • Clinicians should be aware that fixed dose enoxaparin prophylaxis will only provide adequate therapeutic response for a proportion of rehabilitation patients. • The efficacy of fixed-dose enoxaparin prophylaxis is limited and may be influenced by renal function and weight. • A personalized approach to VTE prophylaxis that includes anit-Xa studies and prophylactic dose adjustments should be considered in certain patients, such as those who are underweight, overweight and or have suboptimal renal function. • More studies are required to investigate the interaction of weight and creatinine in order to establish VTE prophylactic dosing guidelines for specific rehabilitation populations.
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依诺肝素用于住院康复护理期间的 VTE 血栓预防:标准固定剂量方案评估
我们的目的是研究住院康复患者每日固定剂量依诺肝素(40 毫克)血栓预防策略的有效性。这是一项观察性、前瞻性、队列研究,纳入了 63 名亚急性缺血性卒中(SAIS)或脊髓损伤(SCI)后接受康复治疗的住院患者,他们都有血栓预防指征。用药后三小时(连续服用依诺肝素三天或三天以上)测量的抗 Xa 水平用于评估依诺肝素的体内活性。抗 Xa 水平在 0.2-0.5 U/ml 之间被视为有效抗血栓活性的证据。我们发现有 7.9% 的患者(5/63)的抗 Xa 水平低于预防水平(0.5 U/ml)。研究发现,抗 Xa 水平与患者的体重和肾功能(以肌酐清除率(CrCl)为标准)成反比(p<0.05)。我们的研究证实,一刀切的静脉血栓栓塞症(VTE)预防方法可能不适用于康复患者群体。固定剂量依诺肝素的预防效果有限,而且可能受到肾功能和体重的影响。本研究表明,对于某些患者,如体重不足、超重或肾功能不佳的患者,应考虑进行抗 Xa 研究并调整依诺肝素的预防剂量。编号:NCT103593291,2018年8月注册。- 临床医生应该意识到,固定剂量依诺肝素预防治疗只能为一部分康复患者提供足够的治疗反应。- 固定剂量依诺肝素预防的疗效有限,并可能受到肾功能和体重的影响。- 对于某些患者,如体重不足、超重或肾功能不佳的患者,应考虑采用个性化的 VTE 预防方法,包括进行 anit-Xa 研究和调整预防剂量。- 需要进行更多的研究来调查体重和肌酐之间的相互作用,以便为特定康复人群制定 VTE 预防剂量指南。
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