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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,123
TRIPcast score calculation
Clinique Universitaire Saint-Luc
Brussels, Belgium
Centre Hospitalier d'Agen
Agen, France
CHU Angers
Angers, France
Centre Hospitalier de Cholet
Cholet, France
Centre Hospitalier Universitaire de Grenoble
Grenoble, France
Centre Hospitalier Le Mans
Le Mans, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Hospitalier d'Orléans
Orléans, France
APHP Bichat
Paris, France
APHP Cochin
Paris, France
...and 5 more locations
Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) among patients with a TRiP(cast) score < 7
To demonstrate the reliability and safety of the decision not to implement thromboprophylaxis in patients with orthopedic immobilization for lower extremity trauma and Trip(cast) \< 7
Time frame: Day 90
Rate of prescription for thromboprophylaxis
comparison between the two period
Time frame: Day 1
Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)
comparison between the two period
Time frame: Day 90
The rate of complications of preventive anticoagulant treatment (bleeding)
comparison between the two period
Time frame: Day 90
The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices
treatment, nurse, blood test...cost of care
Time frame: Day 90
Physicians' satisfaction using likert's scale
5 level ladder : from totally unsatisfied to totally satisfied
Time frame: Day 1
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