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

NCT07863115 | Recruiting

• 1 other identifier: TRiP-cast Score
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Extremity Injuries; Venous Thromboembolism (VTE); Deep Vein Thrombosis; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic venous thromboembolism (VTE)

  Occurrence of objectively confirmed symptomatic venous thromboembolism, including proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)

  Within 45 days after enrollment

Secondary Outcomes (6)

• Incidence of objectively confirmed distal deep vein thrombosis (DVT)

  Within 45 days after enrollment

• Incidence of major and clinically relevant non-major bleeding

  Within 45 days after enrollment

• Adherence to thromboprophylaxis

  Day 7, Day 30, and Day 45

• Medication adherence score measured by the 8-item Morisky Medication Adherence Scale (MMAS-8)

  Day 7, Day 30, and Day 45

• Odds ratios for factors associated with poor adherence to thromboprophylaxis

  Within 45 days after enrollment

Study Arms (3)

LMWH Cohort

Participants with acute lower-limb trauma requiring immobilization who are prescribed low-molecular-weight heparin (LMWH) for venous thromboembolism prophylaxis according to routine clinical practice.

Drug: Low-Molecular-Weight Heparin (LMWH)

DOAC Cohort

Participants with acute lower-limb trauma requiring immobilization who are prescribed a direct oral anticoagulant (DOAC) for venous thromboembolism prophylaxis according to routine clinical practice.

Drug: Direct Oral Anticoagulants (DOACs)

No Thromboprophylaxis Cohort

Participants who do not receive pharmacological thromboprophylaxis because the treating physician determines that anticoagulation is not indicated according to routine clinical practice.

Other: No Thromboprophylaxis Cohort

Interventions

Low-Molecular-Weight Heparin (LMWH) DRUG

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

LMWH Cohort

Direct Oral Anticoagulants (DOACs) DRUG

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

DOAC Cohort

No Thromboprophylaxis Cohort OTHER

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

No Thromboprophylaxis Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult outpatients with acute lower-limb trauma requiring immobilization who are managed in participating emergency departments or orthopedic/trauma outpatient clinics

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

University Hospital Fattouma Bourguiba Monastir

Monastir, Tunisia

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism

Interventions

Heparin, Low-Molecular-Weight; N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Nouira Semir, Professor

CONTACT

0021673106046; semir.nouira@rns.tn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: October 7, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 7, 2026

Record last verified: 2026-07

Locations

TU (1)