Emergency Department, University Hospital Centre Angers, Angers, France
INSERM, CNRS, MITOVASC, Equipe CarMe, SFR ICAT,UNIV Angers, F-CRIN INNOVTE, Angers, France.
BMJ Open. 2021 Jun 28;11(6):e045905. doi: 10.1136/bmjopen-2020-045905.
Patients with lower limb trauma requiring orthopaedic immobilisation may be at risk of venous thromboembolism but opinions differ about who may benefit from thromboprophylactic anticoagulant treatment.The aim of this CASTING study is to demonstrate the safety of thromboprophylaxis based on the Thrombosis Risk Prediction for patients with cast immobilisation (TRiP(cast) score with regards to the 3-month incidence of symptomatic venous thromboembolism events in low-risk patients not receiving thromboprophylaxis, as well as the usefulness of this strategy on the rate of patients receiving anticoagulant treatment in comparison to current practice.
CASTING will be a stepped-wedge cluster randomised controlled clinical trial, performed in 15 emergency departments in France and Belgium. With their informed consent, outpatients admitted to one of the participating emergency departments for a lower limb trauma requiring orthopaedic immobilisation without surgery will be included. All centres will begin the trial with the 'observational period' and, every 2 weeks, 1 centre will be randomly assigned to switch to the 'interventional period' and to apply the TRiP(cast) score, in which only patients with a score ≥7 will receive thromboprophylactic anticoagulant treatment. The primary endpoint is the rate of clinical thromboembolic events within 90 days following the inclusion of low-risk patients not receiving thromboprophylaxis.
The protocol has been approved by the Comité de Protection des Personnes Sud I (Ethics Review ID-RCB: 2019-A01829-48) for France and the Comité d'éthique hôpital-facultaire Saint Luc (N° B403201941338) for Belgium. It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.
NCT04064489.
需要骨科固定的下肢创伤患者可能有静脉血栓栓塞的风险，但关于哪些患者可能受益于预防性抗凝治疗的意见存在分歧。CASTING 研究的目的是证明基于血栓形成风险预测的血栓预防的安全性，该预测针对的是未接受预防性抗凝治疗的低危患者在 Cast 固定期间发生症状性静脉血栓栓塞事件的 3 个月发生率，以及与当前实践相比，这种策略在接受抗凝治疗的患者比例上的有用性。
CASTING 将是一项在法国和比利时的 15 个急诊部门进行的分步楔形集群随机对照临床试验。获得他们的知情同意后，因下肢创伤需要骨科固定而不接受手术的门诊患者将被纳入参与的急诊部门之一。所有中心都将从“观察期”开始，每隔 2 周，就会有 1 个中心被随机分配到“干预期”，并应用 TRiP(cast)评分，只有评分≥7 的患者才会接受预防性抗凝治疗。主要终点是在未接受预防性抗凝治疗的低危患者纳入后 90 天内临床血栓栓塞事件的发生率。
该方案已获得法国 Sud I 保护委员会（伦理审查 ID-RCB：2019-A01829-48）和比利时圣吕克医院伦理委员会（编号 B403201941338）的批准。该方案符合赫尔辛基宣言和良好临床实践指南的规定。本研究的结果将在同行评议的期刊和科学会议上发表。
NCT04064489。
