Lancet:下肢制动患者基于TRIP(CAST)评分的靶向预防性抗凝治疗:一项多中心、阶梯式楔形、随机实施试验
本文由小咖机器人翻译整理
期刊来源:Lancet
原文链接:https://doi.org/10.1016/S0140-6736(23)02369-3
摘要内容如下:
背景
下肢创伤需要固定的急诊患者预防性抗凝治疗是有争议的。使用CAST固定-跳闸(CAST)评分的患者的血栓形成风险预测可以识别静脉血栓栓塞低风险患者的大的亚组,这些患者可以安全地停止预防性抗凝治疗。我们的目的是前瞻性评估静脉血栓栓塞风险低(定义为TRIP(CAST)评分低于7分)的下肢创伤患者停止抗凝治疗的安全性。
方法
CASTING是一项阶梯式楔形、多中心、集群随机试验,采用盲法进行结果评估。在法国和比利时选择了15个急诊科,并随机分配了从控制阶段(即根据医生的惯例开出抗凝处方)转换到干预阶段(即根据TRIP(CAST)评分进行靶向抗凝治疗:如果评分<7,则不开处方;如果评分≥7,则进行抗凝治疗)的交错开始日期。如果患者因下肢创伤需要固定至少7天,并且年龄在18岁或以上,则将其纳入参与的急诊科。主要转归是TRIP(CAST)评分小于7分的患者在介入治疗阶段3个月内症状性静脉血栓栓塞的累积发生率。如果该发生率小于1%,且95%置信区间上限小于2%,则认为靶向治疗策略是安全的。在意向治疗人群中进行初步分析。该研究已在ClinicalTrials.gov(NCT04064489)上注册。
调查结果
在2020年6月16日至2021年9月15日期间,共纳入15组2120名患者。在干预阶段分析的1505例患者中,1159例(77.0%)的TRIP(CAST)评分低于7分,且未接受抗凝治疗。症状性静脉血栓栓塞率为0.7%(95%CI 0.3-1.4,n=8/1159)。在对照组和干预组之间,症状性静脉血栓栓塞的累积率或出血率没有差异。
解释
TRIP(CAST)评分低于7分且未接受抗凝治疗的患者发生静脉血栓栓塞的风险非常低。大部分下肢创伤和制动的患者可以安全地避免血栓预防。
英文原文如下:
Abstracts
BACKGROUND Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7.
METHODS CASTING was a stepped-wedge, multicentre, cluster-randomised trial with blinded outcome assessment. 15 emergency departments in France and Belgium were selected and randomly assigned staggered start dates for switching from the control phase (ie, anticoagulation prescription according to the physician's usual practice) to the intervention phase (ie, targeted anticoagulation according to TRiP(cast) score: no prescription if score <7 and anticoagulation if score was ≥7). Patients were included if they presented to a participating emergency department with lower limb trauma requiring immobilisation for at least 7 days and were aged 18 years or older. The primary outcome was the 3-month cumulative rate of symptomatic venous thromboembolism during the intervention phase in patients with a TRiP(cast) score of less than 7. The targeted strategy was considered safe if this rate was less than 1% with an upper 95% CI of less than 2%. The primary analysis was performed in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT04064489).
FINDINGS Between June 16, 2020, and Sept 15, 2021, 15 clusters and 2120 patients were included. Of the 1505 patients analysed in the intervention phase, 1159 (77·0%) had a TRiP(cast) score of less than 7 and did not receive anticoagulant treatment. The symptomatic venous thromboembolism rate was 0·7% (95% CI 0·3-1·4, n=8/1159). There was no difference between the control and the intervention phases in the cumulative rate of symptomatic venous thromboembolism or in bleeding rates.
INTERPRETATION Patients with a TRiP(cast) score of less than 7 who are not receiving anticoagulation have a very low risk of venous thromboembolism. A large proportion of patients with lower limb trauma and immobilisation could safely avoid thromboprophylaxis.
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