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

NCT ID: NCT04064489

Last Updated: 2022-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2022-02-04

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

neutral

No specific instructions for prescribing prophylaxis or not

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: ACTIVE_COMPARATOR

TRIPscore

Intervention Type: OTHER

TRIPcast score calculation

Interventions

TRIPscore

TRIPcast score calculation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier de Cholet

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Saint-Brieuc

OTHER

Sponsor Role: collaborator

Bichat Hospital

OTHER

Sponsor Role: collaborator

Hôpital Cochin

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: collaborator

Poitiers University Hospital

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

University Hospital, Tours

OTHER

Sponsor Role: collaborator

CHU Rennes - Hopital Pontchaillou

OTHER

Sponsor Role: collaborator

Centre Hospitalier le Mans

OTHER

Sponsor Role: collaborator

Centre Hospitalier d'Agen

OTHER

Sponsor Role: collaborator

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Marie Roy, MD PhD

Role: STUDY_CHAIR

University Hospital, Angers

Locations

Clinique Universitaire Saint-Luc

Brussels, , Belgium

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, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 38368901 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34183341 (View on PubMed)

Other Identifiers

49RC19_0027

Identifier Type: -

Identifier Source: org_study_id