Aspirin and Enoxaparin for VTE in Trauma

Study Overview
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Brief Summary
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The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.

Official Title
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The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial

Conditions
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Venous Thromboembolism, Thromboprophylaxis, Trauma

Intervention / Treatment
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* Drug: Aspirin
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Blunt or penetrating trauma Requires VTE thromboprophylaxis High-risk for VTE Exclusion Criteria: Presence of VTE upon admission Pregnant or nursing Inability to give informed consent by patient or healthcare proxy Contraindication to enoxaparin Contraindication to aspirin Epidural or subdural hematoma Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)<br>Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. | Drug: Aspirin<br>* Daily dose is 81 mg oral tablet<br>Drug: Enoxaparin<br>* Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.<br>|
| Active Comparator: Low Molecular Weight Heparin (LMWH) Alone<br>Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. | Drug: Enoxaparin<br>* Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Venous Thromboembolism | Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan | Up to 2 months of hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hypercoagulability | Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG) | Baseline, up to 2 months hospitalization | 
| Mortality | Mortality will be reported as the number of participants with reported death upon hospital discharge | Up to 2 months of hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism