TRiP-cast score test in adults with acute lower-limb injuries requiring immobilization

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational cohort conducted in Tunisia to externally validate the TRiP(cast) score for identifying patients at higher risk of symptomatic venous thromboembolism, including DVT and PE, after immobilization for acute lower-limb trauma. The study also compares how well patients adhere to prescribed thromboprophylaxis when using LMWH versus DOACs and explores factors linked to adherence, bleeding, and thromboembolic events. Adults aged 18+ with immobilization of the lower limb for at least seven days are enrolled after outpatient evaluation, with follow-up focused on thromboembolism outcomes and treatment adherence. Three arms are observed: LMWH prophylaxis, DOAC prophylaxis, and a no-thromboprophylaxis cohort. Data will inform the score's predictive performance and real-world use of different prophylaxis strategies in this setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 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/mm³).
  * 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.

Where it's running

• University Hospital Fattouma Bourguiba Monastir
  Monastir, Tunisia Recruiting

Study contacts

• Study coordinator: Nouira Semir, Professor
• Email: semir.nouira@rns.tn
• Phone: 0021673106046

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.