Aspirin and Enoxaparin for VTE in Trauma

Phase 4TerminatedNCT02396732

University of Miami31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Venous Thromboembolism Thromboprophylaxis Trauma

Interventions

AspirinDRUG

Daily dose is 81 mg oral tablet

EnoxaparinDRUG

Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ryder Trauma Center

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 2 months of hospitalization

Secondary Outcomes

Change in Hypercoagulability

Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)

Time frame: Baseline, up to 2 months hospitalization

Mortality

Mortality will be reported as the number of participants with reported death upon hospital discharge

Time frame: Up to 2 months of hospitalization

Data from ClinicalTrials.gov

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