Clinical trial NCT04064489: Thromboembolic Risk Stratification by TRiP(Cast) Score to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or castING.
Official title: Thromboembolic Risk Stratification by TRIP Score (Cast) to Guide Physicians in Preventive Treatment Prescriptions for Patients With Lower Limb Trauma Requiring Brace or Casting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Trauma
Venous Thromboembolism
Stratification
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: Centre Hospitalier de Cholet
name: Centre Hospitalier de Saint-Brieuc
name: Bichat Hospital
name: Hôpital Cochin
name: University Hospital, Toulouse
name: University Hospital, Grenoble
name: Centre Hospitalier Régional d'Orléans
name: Poitiers University Hospital
name: Nantes University Hospital
name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: University Hospital, Tours
name: CHU Rennes - Hopital Pontchaillou
name: Centre Hospitalier le Mans
name: Centre Hospitalier d'Agen
First posted: 2019-08-22
Enrollment: 2123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) among patients with a TRiP(cast) score < 7
timeFrame: Day 90
Secondary outcomes:
measure: Rate of prescription for thromboprophylaxis
timeFrame: Day 1
measure: Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)
timeFrame: Day 90
measure: The rate of complications of preventive anticoagulant treatment (bleeding)
timeFrame: Day 90
measure: The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices
timeFrame: Day 90
measure: Physicians' satisfaction using likert's scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique Universitaire Saint-Luc
city: Agen
country: France
facility: Centre Hospitalier d'Agen
city: Angers
country: France
facility: CHU Angers
city: Cholet
country: France
facility: Centre Hospitalier de Cholet
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire de Grenoble
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Orléans
country: France
facility: Centre Hospitalier d'Orléans
city: Paris
country: France
facility: APHP Bichat
city: Paris
country: France
facility: APHP Cochin
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Saint-Brieuc
country: France
facility: Centre Hospitalier de Saint-Brieuc
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse
city: Tours
country: France
facility: Centre Hospitalier Universitaire de Tours
Study officials:
affiliation: University Hospital, Angers
name: Pierre-Marie Roy, MD PhD
role: STUDY_CHAIR
References:
citation: Douillet D, Riou J, Thoma M, Moumneh T, Darsonval A, Trinh-Duc A, Hugli O, Chauvin A, Penaloza A, Roy PM. Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial. BMJ Open. 2021 Jun 28;11(6):e045905. doi: 10.1136/bmjopen-2020-045905.