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

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

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 Overview

• Status: Completed
• Conditions: Venous Thromboembolism; Lower Limb Trauma; Stratification
• Intervention / Treatment: Other: TRIPscore

• Study Type: Interventional
• Enrollment (Actual): 2123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium
    • Clinique Universitaire Saint-Luc
• France
  • Agen, France
    • Centre Hospitalier d'Agen
  • Angers, France
    • CHU Angers
  • Cholet, France
    • Centre Hospitalier de Cholet
  • Grenoble, France
    • Centre Hospitalier Universitaire de Grenoble
  • Le Mans, France
    • Centre Hospitalier Le Mans
  • Nantes, France
    • Centre Hospitalier Universitaire de Nantes
  • Orléans, France
    • Centre Hospitalier d'Orléans
  • Paris, France
    • APHP Bichat
  • Paris, France
    • APHP Cochin
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers
  • Rennes, France
    • Centre Hospitalier Universitaire de Rennes
  • Saint-Brieuc, France
    • Centre Hospitalier de Saint-Brieuc
  • Toulouse, France
    • Centre Hospitalier Universitaire de Toulouse
  • Tours, France
    • Centre Hospitalier Universitaire de Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: neutral; No specific instructions for prescribing prophylaxis or not
Active Comparator: 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)	Other: TRIPscore; TRIPcast score calculation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Collaborators: Poitiers University Hospital; Hôpital Cochin; University Hospital, Grenoble; Cliniques universitaires Saint-Luc- Université Catholique de Louvain; University Hospital, Toulouse; Nantes University Hospital; University Hospital, Tours; Centre Hospitalier Régional d'Orléans; Bichat Hospital; Centre Hospitalier le Mans; Centre Hospitalier d'Agen; Centre Hospitalier de Cholet; Centre Hospitalier de Saint-Brieuc; CHU Rennes - Hopital Pontchaillou
• Investigators: Study Chair: Pierre-Marie Roy, MD PhD, University Hospital, Angers

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2020
• Primary Completion (Actual): February 4, 2022
• Study Completion (Actual): February 4, 2022

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Wounds and Injuries; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 49RC19_0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be available. The study protocol, the Statistical Analysis Plan, Informed consent form will be available immediately following publication. No end date.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No