Lower Extremity InjuriesTRiP-VALIDNCT07863115
TRiP-cast Score Validation and Evaluation of Adherence to Preventive Anticoagulant Treatment in Patients With Lower Limb Trauma Requiring Immobilization
An observational study of Lower Extremity Injuries and Venous Thromboembolism (VTE), run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Injuries, Venous Thromboembolism (VTE), Deep Vein Thrombosis
- What is being tested?
- Low-Molecular-Weight Heparin (LMWH), Direct Oral Anticoagulants (DOACs) and No Thromboprophylaxis Cohort
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Sep 2025to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients with acute lower-limb trauma requiring immobilization who are managed in participating emergency departments or orthopedic/trauma outpatient clinics
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site, 1 recruiting
- Recruiting
University Hospital Fattouma Bourguiba Monastir
Monastir
Nouira Semir, Professor, 0021673106046, semir.nouira@rns.tn
About this study
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
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
- Being tested
- Low-Molecular-Weight Heparin (LMWH), Direct Oral Anticoagulants (DOACs), No Thromboprophylaxis Cohort
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Molecular-Weight Heparin (LMWH)Drug
Low-molecular-weight heparin prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.
Direct Oral Anticoagulants (DOACs)Drug
Direct oral anticoagulants prescribed for venous thromboembolism prophylaxis according to the treating physician's routine clinical practice.
No Thromboprophylaxis CohortOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No Thromboprophylaxis Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic venous thromboembolism (VTE)
Occurrence of objectively confirmed symptomatic venous thromboembolism, including proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
Measured: Within 45 days after enrollment
Secondary outcomes (6)
Incidence of objectively confirmed distal deep vein thrombosis (DVT)
Occurrence of objectively confirmed distal DVT diagnosed by compression ultrasonography
Measured: Within 45 days after enrollment
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.
Measured: Within 45 days after enrollment
Adherence to thromboprophylaxis
Percentage of participants adherent to prescribed anticoagulant thromboprophylaxis, defined as taking at least 80% of prescribed doses.
Measured: Day 7, Day 30, and Day 45
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..
Measured: Day 7, Day 30, and Day 45
Odds ratios for factors associated with poor adherence to thromboprophylaxis
Odds ratios (ORs) with 95% confidence intervals for the association between predefined demographic and clinical factors and poor adherence to prescribed anticoagulant thromboprophylaxis.
Measured: Within 45 days after enrollment
Clinical characteristics associated with symptomatic venous thromboembolism
Comparison of baseline demographic and clinical characteristics between participants who develop symptomatic VTE and those who do not.
Measured: Within 45 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863115
- Sponsor's protocol ID
- TRiP-cast Score
- Acronym
- TRiP-VALID
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No