Lovenox 30 mg Twice Daily (BID) Versus 40 mg Once Daily (QD)

Study Overview
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Brief Summary
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The risk of developing a blood clot occurs in up to 60% of all critical care patients. Many times enoxaparin (or Lovenox) is given to patients who are at a higher risk of developing clots in their legs or lungs. There are two standard doses of enoxaparin that are recommended by the drug companies. These two doses have never been directly compared in trauma, general, and vascular surgery patients. The purposes of this study are: to compare the development of blood clots in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily of enoxaparin. to determine if there is higher risk of bleeding complications in patients receiving 30mg twice daily of enoxaparin compared to patients receiving 40mg once daily. Patients enrolled into the study will be randomized to receive enoxaparin, 30mg twice daily or enoxaparin, 40mg once daily. Patients will then be monitored for signs and symptoms of blood clots. At the time of discharge (or before, if medically indicated), an ultrasound test will be performed to look for blood clots in the patient's legs. The investigators will compare incidence of blood clots formed between the 2 groups of patients to determine if one dose of enoxaparin relates to a lower rate of blood clots in critically ill patients. The investigators will also compare the incidence of bleeding complications between the 2 groups.

Official Title
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A Prospective Randomized Trial Comparing Two Standard Doses of Enoxaparin for the Prevention of Thromboembolism in Surgical Patients

Conditions
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Trauma, Surgery, Deep Vein Thrombosis (DVT), Thromboembolic Events

Intervention / Treatment
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* Drug: Enoxaparin Sodium Injection 30 mg BID
* Drug: Enoxaparin Sodium Injection 40 mg QD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted patients requiring prophylactic dosing of enoxaparin (Lovenox) Admitted to the trauma or surgical service Age greater than 15 years Exclusion Criteria: Unable to obtain consent from patient or authorized representative Presence of intracranial hemorrhage Receiving therapeutic dose of enoxaparin (Lovenox) Receiving other forms of anticoagulation Presence of renal failure requiring non-standard dosing regimen

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 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 |
| --- | --- |
| Active Comparator: Enoxaparin Sodium Injection 30 mg BID<br>Subjects are randomized to receive 30 mg twice daily of enoxaparin. | Drug: Enoxaparin Sodium Injection 30 mg BID<br> <br> * Other names: Lovenox;|
| Active Comparator: Enoxaparin Sodium Injection 40 mg QD<br>Subjects are randomized to receive 40 mg once daily of enoxaparin. | Drug: Enoxaparin Sodium Injection 40 mg QD<br> <br> * Other names: Lovenox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic events | Daily monitoring per standard of care for the development of thromboembolic events. | Daily, up to Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in bleeding complications | Daily monitoring for an increase in bleeding complications due to study drug dose and regime. | Daily, up to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trauma, Surgery, Enoxaparin, DVTs, Thromboembolic events