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

NCT04064489 | Completed DMC

• 1 other identifier: 49RC19_0027
• Study Type: interventional
• Target: 2,123
• Locations: 2 countries
• Sites: 15

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.

Conditions

Lower Limb Trauma; Venous Thromboembolism; Stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Rate of prescription for thromboprophylaxis

  Day 1

• Rate of symptomatic venous thromboembolic events (deep vein thrombosis and / or pulmonary embolism) (whole population)

  Day 90

• The rate of complications of preventive anticoagulant treatment (bleeding)

  Day 90

• The direct cost of preventive anticoagulant treatment when the TRiP(cast) score is applied compared to current practices

  Day 90

• Physicians' satisfaction using likert's scale

  Day 1

Study Arms (2)

neutral

NO INTERVENTION

No specific instructions for prescribing prophylaxis or not

TRIPscore

ACTIVE COMPARATOR

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

Interventions

TRIPscore OTHER

TRIPcast score calculation

TRIPscore

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient with anticoagulant treatment at the time of trauma,
• Trauma requiring hospitalization of more than 48 hours,
• 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.

Sponsors & Collaborators

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

Study Sites (15)

Clinique Universitaire Saint-Luc

Brussels, Belgium

Location

Centre Hospitalier d'Agen

Agen, France

Location

CHU Angers

Angers, France

Location

Centre Hospitalier de Cholet

Cholet, France

Location

Centre Hospitalier Universitaire de Grenoble

Grenoble, France

Location

Centre Hospitalier Le Mans

Le Mans, France

Location

Centre Hospitalier Universitaire de Nantes

Nantes, France

Location

Centre Hospitalier d'Orléans

Orléans, France

Location

APHP Bichat

Paris, France

Location

APHP Cochin

Paris, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, France

Location

Centre Hospitalier de Saint-Brieuc

Saint-Brieuc, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Centre Hospitalier Universitaire de Tours

Tours, France

Location

Related Publications (2)

• Douillet D, Penaloza A, Viglino D, Banihachemi JJ, Abboodi A, Helderle M, Montassier E, Balen F, Brice C, Laribi S, Duchenoy T, Vives P, Soulat L, Marjanovic N, Moumneh T, Savary D, Riou J, Roy PM. Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial. Lancet. 2024 Mar 16;403(10431):1051-1060. doi: 10.1016/S0140-6736(23)02369-3. Epub 2024 Feb 15.

  PMID: 38368901 DERIVED

• 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.

  PMID: 34183341 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pierre-Marie Roy, MD PhD

  University Hospital, Angers

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 22, 2019
• Study Start: June 16, 2020
• Primary Completion: February 4, 2022
• Study Completion: February 4, 2022
• Last Updated: August 11, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (14)