Thromboembolic Risk Stratification by TRiP(Cast) Score to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or castING.

Summary

Non-surgical traumas to the lower limbs that require orthopedic immobilisation (plaster or splint) are a frequent reason for going to accident and emergency. Due to venous stasis caused by immobilisation, hypercoagulable states and vascular injuries brought on by the trauma, these patients are at risk of developing VTE. For this reason, it is current practice in France and Belgium for the majority of patients to receive a preventative anticoagulant treatment. However, the benefit of this treatment, which has a considerable cost, is controversial. Contrary to French recommendations, American recommendations from 2012 actually advise against systematic preventative medicine, with prevention appearing to be effective primarily in studies with restrictive inclusion criteria. The most significant randomised controlled study on the subject did not show the benefit of low-molecular-weight heparin (LMWH) on the rate of symptomatic VTE among 1,435 non-selected patients. Therefore, in 2017, the Cochrane meta-analysis concluded that stratification of the risk of thromboembolism is required.

For this purpose, in collaboration with the Dutch team of Nemeth et al. we have recently developed a risk stratification model that takes into consideration the patient's characteristics, the type of immobilisation and the severity of the trauma: the TRiP(cast) score. This score is applied retrospectively to a large cohort and demonstrates excellent prognostic performances (AUC (area under the curve) of 0.74). In addition, when using a \<7 limits, it makes it possible to identify a large group of patients at very low risk of developing VTE (negative predictive value: 99.2%).

The aim of the CASTING study is to prospectively demonstrate the reliability and utility of the TRiP(cast) score by showing that patients with orthopaedic immobilisation of a lower limb who are not receiving preventative treatment on the basis of a TRiP(cast) score of \<7 have a very low rate of symptomatic VTE, which allows for a significant reduction in prescriptions of anticoagulants in comparison with prior practices.

Conditions

• Lower Limb Trauma
• Venous Thromboembolism
• Stratification

Interventions

OTHER

TRIPscore

TRIPcast score calculation

Sponsors & Collaborators

• Centre Hospitalier de Cholet

  collaborator OTHER

• Centre Hospitalier de Saint-Brieuc

  collaborator OTHER

• Bichat Hospital

  collaborator OTHER

• Hôpital Cochin

  collaborator OTHER

• University Hospital, Toulouse

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• Centre Hospitalier Régional d'Orléans

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• CHU Rennes - Hopital Pontchaillou

  collaborator OTHER

• Centre Hospitalier le Mans

  collaborator OTHER

• Centre Hospitalier d'Agen

  collaborator OTHER

• University Hospital, Angers

  lead OTHER_GOV

Principal Investigators

• Pierre-Marie Roy, MD PhD · University Hospital, Angers

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-16

Primary Completion

2022-02-04

Completion

2022-02-04

Countries

• Belgium
• France

Study Locations