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临床试验/NCT06416280
NCT06416280招募中不适用

Inter-observer Reliability of the Assessment of the Risk of Developing a Venous Thromboembolic Event, the TRiP(Cast) Score, in Patients With Trauma to a Lower Limb Requiring Immobilisation

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2024年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
302
试验地点
1
主要终点
The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation.

研究概览

简要总结

The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score.

详细描述

Trauma to the lower limbs requiring orthopedic immobilisation (plaster cast or splint) is a frequent reason for seeking emergency care. Because of the venous stasis caused by immobilisation, hypercoagulability and vascular lesions induced by the trauma, these patients are at risk of developing a venous thromboembolic event (VTE). This risk is estimated at around 2% (95% CI 1.3 to 2.7). To reduce the risk of thrombosis, preventive anticoagulants, mainly low molecular weight heparins (LMWH) and fondaparinux, have been shown to be beneficial. However, not all patients have the same thromboembolic risk factors. A targeted strategy should therefore be used to avoid prescribing treatment to low-risk patients and to prescribe it to the sub-group of patients at high risk. The TRiP(cast) score has been developed and validated for this purpose.

In the CASTING study (randomised stepped-wedge trial), patients not receiving thromboprophylaxis on the basis of a TRiP(cast) score <7 had a 3-month rate of symptomatic thromboembolic events of 0.70% (95% CI: 0.21-1.17). Use of the TRiP(cast) score reduced the rate of anticoagulation prescriptions by 26% (24.5% versus 50.4%) without increasing the rate of thromboembolic events at 3 months. Since this study, French recommendations concerning the prescription of anticoagulation treatments have been updated.

Since this study, French recommendations concerning the prescription of preventive anticoagulant treatment have been updated by the SFMU (French Society of Emergency Medicine) and the SFMV (French Society of Vascular Medicine). They were presented in June 2023 and are now applied in all emergency facilities. During the review for the publication of the CASTING study, it was discussed whether it would be useful to evaluate the reliability of this score.

However, the reliability of the measurement and the reproducibility of the score have never been assessed. Given the importance of assessing the risk of venous thromboembolism in patients with lower-limb trauma when deciding whether or not to prescribe thromboprophylaxis, this assessment is essential.

Although this score appears to be objective, there are still items where interpretation may be different. For example, the type of immobilisation cannot be transposed perfectly to all existing immobilisation methods. This study will also be carried out in other European countries. The types of immobilisation vary considerably from one country to another, and the interpretation of certain items could be different. The interpretation of patient characteristics may also vary.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consultation in one of the emergency departments participating in the study,
  • Isolated trauma to a lower limb,
  • Rigid immobilisation (plaster or resin) or semi-rigid immobilisation for an expected duration of at least 7 days,
  • Patient over 18 years of age,
  • Patient affiliated to or benefiting from a social security scheme,
  • Patients who have signed a prior informed consent form

排除标准

  • Patient taking anticoagulant treatment at the time of the trauma,
  • Trauma requiring hospitalisation for more than 48 hours,
  • Pregnant, breast-feeding or parturient patients,
  • Patient deprived of liberty by judicial or administrative decision,
  • Patient under compulsory psychiatric care,
  • Patient under legal protection,
  • Patients unable to give their free and informed consent

结局指标

主要结局

The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation.

时间窗: Day 0

Outcome measure : The rate of agreement or "concordance" will be estimated by the Kappa coefficient.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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