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.
Age ≥18 years.
Fracture (e.g., foot, ankle, leg, or distal femur) requiring immobilization, or
Grade II or III ankle or knee sprain requiring immobilization, or
Acute Achilles tendon rupture requiring immediate non-surgical immobilization.
Planned or initial hospitalization for more than 24 hours.
History of venous thromboembolism within the previous 3 months.
Current oral or injectable anticoagulant therapy for another indication.
Active bleeding.
Adult outpatients with acute lower-limb trauma requiring immobilization who are managed in participating emergency departments or orthopedic/trauma outpatient clinics
Cohort
Prospective
Low-Molecular-Weight Heparin (LMWH)
DrugLow-molecular-weight heparin prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.
Direct Oral Anticoagulants (DOACs)
DrugDirect oral anticoagulants prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.
No Thromboprophylaxis Cohort
Other interventionNo 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
Incidence of symptomatic venous thromboembolism (VTE)
Occurrence of objectively confirmed symptomatic venous thromboembolism, including proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Incidence of objectively confirmed distal deep vein thrombosis (DVT)
Occurrence of objectively confirmed distal DVT diagnosed by compression ultrasonography
Incidence of major and clinically relevant non-major bleeding
Occurrence of major bleeding and clinically relevant non-major bleeding defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria.
Adherence to thromboprophylaxis
Percentage of participants adherent to prescribed anticoagulant thromboprophylaxis, defined as taking at least 80% of prescribed doses.
Medication adherence score measured by the 8-item Morisky Medication Adherence Scale (MMAS-8)
MMAS-8 total score, ranging from 0 to 8, with higher scores indicating higher medication adherence..
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