Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients

Study Overview
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Brief Summary
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A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.

Detailed Description
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A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).

Official Title
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Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients

Conditions
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Venous Thrombosis

Intervention / Treatment
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* Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily
* Drug: Lovenox 40mg SC Daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female > 40 years of age. Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days. Pts admitted to the MICU, Regional Heart Units of LV-MHC Exclusion Criteria: Surgical primary admission diagnosis Recent surgery within the past 12 weeks Planned surgery on the current admission Pregnancy Vent-dependent respiratory failure requiring intubation for >24 hours. Known current DVT or PE prior to enrollment in study. Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient. Hx of prior or current lower upper or lower GI bleed. Platelet count < 100,000 per cubic millimeter Current or prior anticoagulation within the prior 48 hours, excluding a single dose &lor 24 hour period of prophylactic agent Bacterial endocarditis. Hemophilia Hypersensitivity to aspirin. Hypersensitivity to Arixtra or Lovenox Hx of hemorrhagic or ischemic stroke < 3 months prior to enrolling Hematocrit < 28%. SBP >200 mmHg or DBP >120 mmHg Positive for occult blood in stool. Admission to hospital for > 48 hours prior to randomization Documented congenital or acquired bleeding disorder Indwelling intrathecal or epidural catheter Life expectancy < 30 days Inability to have a flu assessment post-discharge from the hospital

Ages Eligible for Study
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Minimum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arixtra (Fondaparinox) 2.5 mg SC Daily<br>Arixtra (Fondaparinox) 2.5 mg SC Daily | Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily<br>* Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm<br>* Other names: fondaparinux;|
| Active Comparator: Lovenox 40mg SC Daily<br>Lovenox 40mg SC Daily | Drug: Lovenox 40mg SC Daily<br>* Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm<br>* Other names: enoxaparin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u | Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deep Vein Thrombosis | Confirmed by Lower Extremity Ultra-sonogram | 14 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bleeding rates, Prophylaxis for deep vein thrombosis