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

NCT06416280 | Recruiting

• 1 other identifier: 24_0131
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Thromboprophylaxis; Lower Limb Trauma; Immobilisation Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Assessment of the TRiP(cast) score OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Emergency department patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

DOUILLET Delphine

Angers, France

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Delphine DOUILLET

  University Hospital, Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine DOUILLET

CONTACT

(0)241353637; Delphine.Douillet@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: May 16, 2024
• Primary Completion: May 20, 2025
• Study Completion: December 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)