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

Not Applicable

Terminated

Interventions: Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily
Drug: Lovenox 40mg SC Daily

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arixtra (Fondaparinox) 2.5 mg SC Daily	Arixtra (Fondaparinox) 2.5 mg SC Daily	Arixtra (Fondaparinox) 2.5 mg SC Daily
Lovenox 40mg SC Daily	Lovenox 40mg SC Daily	Lovenox 40mg SC Daily

Primary Outcome Measures

Name	Time	Method
Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u	14 days	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.

Secondary Outcome Measures