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

Recruitingn/aAges 18 Years - anyAllUniversity of Monastir
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In plain words

What the trial is, and whether it could suit you

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 a

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years. * Acute lower-limb trauma within 72 hours before enrollment: * 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. * Immobilization with a cast or rigid orthosis (e.g., splint or walking boot) expected to last at least 7 days. * Initial outpatient management in an emergency department or outpatient orthopedic/trauma clinic. * No planned hospitalization exceeding 24 hours for the injury or its immediate complications. * Written informed consent provided before study enrollment. Exclusion Criteria: * 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. * Known major contraindication to anticoagulant therapy, including: * Active bleeding. * Untreated active peptic ulcer disease. * Severe thrombocytopenia (platelet count \<50,000/mmยณ). * Severe hepatic impairment. * Severe renal impairment (estimated creatinine clearance \<30 mL/min using the CKD-EPI equation). * Open lower-limb trauma requiring immediate surgery (except simple fracture reduction and immobilization). * Inability to understand the study procedures or provide written informed consent. * Pregnancy or breastfeeding. * Concurrent participation in another clinical study that may interfere with the objectives of the present study.
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What it tests

  • Low-Molecular-Weight Heparin (LMWH)
  • Direct Oral Anticoagulants (DOACs)
  • No Thromboprophylaxis Cohort
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Where

1 site
University Hospital Fattouma Bourguiba Monastir
Monastir, Tunisia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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