Thromboprophylaxis, Trauma, Venous Thromboembolism
Conditions
Keywords
Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism
Brief summary
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.
Interventions
DRUGAspirin
Daily dose is 81 mg oral tablet
DRUGEnoxaparin
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Venous Thromboembolism | Up to 2 months of hospitalization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hypercoagulability | Baseline, up to 2 months hospitalization | Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG) |
| Mortality | Up to 2 months of hospitalization | Mortality will be reported as the number of participants with reported death upon hospital discharge |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LMWH + ASA Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. | 14 |
| LMWH Alone Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. | 17 |
| Total | 31 |
Baseline characteristics
| Characteristic | LMWH + ASA | LMWH Alone | Total |
|---|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 13 | 40 years STANDARD_DEVIATION 16 | 40 years STANDARD_DEVIATION 14 |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic / Latino | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 9 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 1 / 17 |
| other Total, other adverse events | 1 / 14 | 1 / 17 |
| serious Total, serious adverse events | 2 / 14 | 4 / 17 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LMWH + ASA | Incidence of Venous Thromboembolism | 1 incidents |
| LMWH Alone | Incidence of Venous Thromboembolism | 3 incidents |
Secondary
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
Population: Data analysis was not completed for this outcome as samples were not collected as per protocol.
Secondary
Mortality
Mortality will be reported as the number of participants with reported death upon hospital discharge
Time frame: Up to 2 months of hospitalization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LMWH + ASA | Mortality | 0 Participants |
| LMWH Alone | Mortality | 1 Participants |