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RECRUITING
NCT07863115

TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization

Sponsor: University of Monastir

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, observational cohort study designed to externally validate the Trauma-Related Immobilization-related Prophylaxis (TRiP(cast)) score in Tunisian adults with acute lower-limb trauma requiring immobilization and managed as outpatients. The study will assess the ability of the TRiP(cast) score to identify patients at increased risk of symptomatic venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism. A secondary objective is to evaluate adherence to prescribed thromboprophylaxis and to compare adherence between patients receiving low-molecular-weight heparin (LMWH) and those receiving direct oral anticoagulants (DOACs). Factors associated with treatment adherence, bleeding events, and thromboembolic outcomes will also be investigated. Patients aged 18 years or older with acute lower-limb trauma requiring immobilization for at least 7 days will be enrolled consecutively and followed prospectively. The decision to prescribe thromboprophylaxis and the choice of anticoagulant will remain entirely at the discretion of the treating physician according to routine clinical practice. Study investigators will not influence treatment decisions. The results are expected to provide external validation of the TRiP(cast) score in the Tunisian population and improve risk stratification and thromboprophylaxis management in ambulatory patients with lower-limb trauma.

Official title: Validation of the TRiP-cast Score and Evaluation of Adherence to Preventive Anticoagulant Treatment in Non-Hospitalized Patients With Lower Limb Trauma Requiring Immobilization

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2025-09-01

Completion Date

2028-12-31

Last Updated

2026-10-07

Healthy Volunteers

No

Interventions

DRUG

Low-Molecular-Weight Heparin (LMWH)

Low-molecular-weight heparin prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.

DRUG

Direct Oral Anticoagulants (DOACs)

Direct oral anticoagulants prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.

OTHER

No Thromboprophylaxis Cohort

No anticoagulant prophylaxis is prescribed as part of routine clinical care. Treatment decisions are made solely by the treating physician and are not influenced by the study

Locations (1)

University Hospital Fattouma Bourguiba Monastir

Monastir, Tunisia