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Terminated due to futility and less subjects meeting entry criteria
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Molecular Weight Heparin (LMWH) + Aspirin (ASA) | Experimental | Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. |
|
| Low Molecular Weight Heparin (LMWH) Alone | Active Comparator | Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Daily dose is 81 mg oral tablet |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Proctor, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryder Trauma Center | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LMWH + ASA | Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. |
| FG001 | LMWH Alone | Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | LMWH + ASA | Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. |
| BG001 | LMWH Alone | Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | incidents | Up to 2 months of hospitalization |
|
Up to 2 months
For purposes of this study we are only collecting and reporting the following adverse events: Acute Respiratory Syndrome, Altered Mental Status, Bacteremia, Pneumonia, Venous Thromboembolism, Bleeding Complications, Acute Kidney Injury, Urinary Tract Infection, Surgical Site Infection and Mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LMWH + ASA | Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered Mental Status | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Proctor | University of Miami | 305-585-1178 | kproctor@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2016 | Oct 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Enoxaparin |
| Drug |
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician. |
|
Mortality will be reported as the number of participants with reported death upon hospital discharge
| Up to 2 months of hospitalization |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Change in Hypercoagulability | Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG) | Data analysis was not completed for this outcome as samples were not collected as per protocol. | Posted | Baseline, up to 2 months hospitalization |
|
|
| Secondary | Mortality | Mortality will be reported as the number of participants with reported death upon hospital discharge | Posted | Count of Participants | Participants | Up to 2 months of hospitalization |
|
|
|
| 0 |
| 14 |
| 2 |
| 14 |
| 1 |
| 14 |
| EG001 | LMWH Alone | Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge. | 1 | 17 | 4 | 17 | 1 | 17 |
| Venous Thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bacteremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |