Inter-observer Reliability of the TRiP(Cast) Score in Patients With Trauma to a Lower Limb Requiring Immobilisation

Pulmonary Embolism Clinical Trial

— CCASTING  

Official title:

Inter-observer Reliability of the Assessment of the Risk of Developing a Venous Thromboembolic Event, the TRiP(Cast) Score, in Patients With Trauma to a Lower Limb Requiring Immobilisation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06416280
• Other study ID #: 24_0131
• Status: Recruiting
• Start date: May 16, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: University Hospital, Angers
• Contact: Delphine DOUILLET
• Phone: (0)241353637
• Email: Delphine.Douillet[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study isto evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score.

Description:

Trauma to the lower limbs requiring orthopedic immobilisation (plaster cast or splint) is a frequent reason for seeking emergency care. Because of the venous stasis caused by immobilisation, hypercoagulability and vascular lesions induced by the trauma, these patients are at risk of developing a venous thromboembolic event (VTE). This risk is estimated at around 2% (95% CI 1.3 to 2.7). To reduce the risk of thrombosis, preventive anticoagulants, mainly low molecular weight heparins (LMWH) and fondaparinux, have been shown to be beneficial. However, not all patients have the same thromboembolic risk factors. A targeted strategy should therefore be used to avoid prescribing treatment to low-risk patients and to prescribe it to the sub-group of patients at high risk. The TRiP(cast) score has been developed and validated for this purpose.

In the CASTING study (randomised stepped-wedge trial), patients not receiving thromboprophylaxis on the basis of a TRiP(cast) score <7 had a 3-month rate of symptomatic thromboembolic events of 0.70% (95% CI: 0.21-1.17). Use of the TRiP(cast) score reduced the rate of anticoagulation prescriptions by 26% (24.5% versus 50.4%) without increasing the rate of thromboembolic events at 3 months. Since this study, French recommendations concerning the prescription of anticoagulation treatments have been updated.

Since this study, French recommendations concerning the prescription of preventive anticoagulant treatment have been updated by the SFMU (French Society of Emergency Medicine) and the SFMV (French Society of Vascular Medicine). They were presented in June 2023 and are now applied in all emergency facilities. During the review for the publication of the CASTING study, it was discussed whether it would be useful to evaluate the reliability of this score.

However, the reliability of the measurement and the reproducibility of the score have never been assessed. Given the importance of assessing the risk of venous thromboembolism in patients with lower-limb trauma when deciding whether or not to prescribe thromboprophylaxis, this assessment is essential.

Although this score appears to be objective, there are still items where interpretation may be different. For example, the type of immobilisation cannot be transposed perfectly to all existing immobilisation methods. This study will also be carried out in other European countries. The types of immobilisation vary considerably from one country to another, and the interpretation of certain items could be different. The interpretation of patient characteristics may also vary.

Furthermore, this score has never been compared with the clinician's implicit "gestalt" probability, which is used to define patients at risk of venous thromboembolic events.

It is a real challenge when implementing scores to assess their added value compared with clinical intuition. The use of scores has an initial educational objective, but it is important to know whether clinical intuition would be sufficient to assess this venous thromboembolic risk.

The aim of the study is to evaluate the inter-observer reliability of the assessment of venous thromboembolic risk using the TRiP(cast) score in patients presenting with trauma to a lower limb requiring immobilisation, and of the clinicians' assessment using the physician's implicit probability (gestalt) compared with the use of the TRiP(cast) score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: December 30, 2025
• Est. primary completion date: May 20, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consultation in one of the emergency departments participating in the study,

• Isolated trauma to a lower limb,

• Rigid immobilisation (plaster or resin) or semi-rigid immobilisation for an expected duration of at least 7 days,

• Patient over 18 years of age,

• Patient affiliated to or benefiting from a social security scheme,

• Patients who have signed a prior informed consent form

Exclusion Criteria:

• Patient taking anticoagulant treatment at the time of the trauma,

• Trauma requiring hospitalisation for more than 48 hours,

• Pregnant, breast-feeding or parturient patients,

• Patient deprived of liberty by judicial or administrative decision,

• Patient under compulsory psychiatric care,

• Patient under legal protection,

• Patients unable to give their free and informed consent

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Embolism
• Lower Limb Trauma
• Pulmonary Embolism
• Thromboembolism
• Thromboprophylaxis
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis
• Wounds and Injuries

Intervention

Other:
• Assessment of the TRiP(cast) score
In patients presenting to the emergency department with trauma to a lower limb, the TRiP(cast) score is assessed in accordance with the recommendations. If the patient does not object. The attending physician will then be asked to fill in his implicit assessment of the risk of venous thromboembolism on a paper CRF and then to complete his assessment of the TRiP(cast) score. He will then be free to decide whether or not to anticoagulate the patient. At the same time, a doctor not involved in the patient's care will assess the TRiP(cast) score and record it on a paper CRF. The second doctor's assessment will be independent and will have no impact on the patient's management. The CRFs will then be analysed and stored. Data will be anonymised during data collection and each patient will be assigned an anonymity number.

Locations

Country	Name	City	State
France	DOUILLET Delphine	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary aim is to assess the inter-observer reliability of venous thromboembolic risk assessment using the TRiP(cast) score in patients with lower limb trauma requiring immobilisation.	Outcome measure : The rate of agreement or "concordance" will be estimated by the Kappa coefficient.	Day 0