Thromboembolic Risk Stratification by TRiP(Cast) Score to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or castING.
- Conditions
- Venous ThromboembolismLower Limb TraumaStratification
- Interventions
- Other: TRIPscore
- Registration Number
- NCT04064489
- Lead Sponsor
- University Hospital, Angers
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2123
- Consultation in one of the emergency department participating in the study,
- Isolated trauma from lower limb,
- Rigid (plaster or resin) or semi-rigid immobilization for an assumed duration of at least 7 days,
- Adults (18 years),
- Affiliated patient or beneficiary of a social security,
- Patient with prior informed consent.
- Patient with anticoagulant treatment at the time of trauma,
- Trauma requiring hospitalization of more than 48 hours,
- Co-morbidity(s) requiring hospitalization of more than 48 hours at the time of inclusion,
- Any factor making 90-day follow-up impossible,
- Pregnant, nursing or childbearing patient,
- Patient deprived of liberty by judicial or administrative decision,
- Patient undergoing psychiatric care under duress,
- Patient subject to a legal protection measure,
- Patient unable to give free and informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TRIPscore TRIPscore calculation of the TRIPcast score and prescription of prophylactic or not according to the result (score \> or = 7 : treatment (low molecular weight heparin or fondaparinux); score \< 7 : no treatment)
- Primary Outcome Measures
Name Time Method Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) among patients with a TRiP(cast) score < 7 Day 90 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
- Secondary Outcome Measures
Name Time Method Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population) Day 90 comparison between the two period
Rate of prescription for thromboprophylaxis Day 1 comparison between the two period
Physicians' satisfaction using likert's scale Day 1 5 level ladder : from totally unsatisfied to totally satisfied
The rate of complications of preventive anticoagulant treatment (bleeding) Day 90 comparison between the two period
The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices Day 90 treatment, nurse, blood test...cost of care
Trial Locations
- Locations (15)
APHP Cochin
🇫🇷Paris, France
Clinique Universitaire Saint-Luc
🇧🇪Bruxelles, Belgium
Centre Hospitalier d'Agen
🇫🇷Agen, France
Centre Hospitalier de Cholet
🇫🇷Cholet, France
CHU Angers
🇫🇷Angers, France
Centre Hospitalier Universitaire de Grenoble
🇫🇷Grenoble, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Centre Hospitalier d'Orléans
🇫🇷Orléans, France
Centre Hospitalier Universitaire de Nantes
🇫🇷Nantes, France
APHP Bichat
🇫🇷Paris, France
Centre Hospitalier Universitaire de Rennes
🇫🇷Rennes, France
Centre Hospitalier de Saint-Brieuc
🇫🇷Saint-Brieuc, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷Toulouse, France
Centre Hospitalier Universitaire de Tours
🇫🇷Tours, France