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

Venous Thromboembolism Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064489
• Other study ID #: 49RC19_0027
• Status: Completed
• Phase: N/A
• Start date: June 16, 2020
• Est. completion date: February 4, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2123
• Est. completion date: February 4, 2022
• Est. primary completion date: February 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Limb Trauma
• Stratification
• Thromboembolism
• Venous Thromboembolism
• Wounds and Injuries

Intervention

Other:
• TRIPscore
TRIPcast score calculation

Locations

Country	Name	City	State
Belgium	Clinique Universitaire Saint-Luc	Bruxelles
France	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	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Centre Hospitalier Universitaire de Rennes	Rennes
France	Centre Hospitalier de Saint-Brieuc	Saint-Brieuc
France	Centre Hospitalier Universitaire de Toulouse	Toulouse
France	Centre Hospitalier Universitaire de Tours	Tours

Sponsors (15)

Lead Sponsor

Collaborator

University Hospital, Angers

Bichat Hospital, Centre Hospitalier d'Agen, Centre Hospitalier de Cholet, Centre Hospitalier de Saint-Brieuc, Centre Hospitalier le Mans, Centre Hospitalier Régional d'Orléans, CHU Rennes - Hopital Pontchaillou, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Hôpital Cochin, Nantes University Hospital, Poitiers University Hospital, University Hospital, Grenoble, University Hospital, Toulouse, University Hospital, Tours

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 90
Secondary	Rate of prescription for thromboprophylaxis	comparison between the two period	Day 1
Secondary	Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)	comparison between the two period	Day 90
Secondary	The rate of complications of preventive anticoagulant treatment (bleeding)	comparison between the two period	Day 90
Secondary	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	Day 90
Secondary	Physicians' satisfaction using likert's scale	5 level ladder : from totally unsatisfied to totally satisfied	Day 1