Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
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.
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).
Status: Terminated (N/A). Started on September 1st, 2007.
Enrollment: 50 subjects
Study Type: Interventional
Study Design:
- Allocation: Randomized
- Endpoint Classification: Safety/Efficacy Study
- Intervention Model: Parallel Assignment
- Masking: Double Blind (Subject
- Investigator
- Outcomes Assessor)
- Primary Purpose: Prevention
Conditions:
Interventions:
- Drug: fondaparinux (Arixtra vs Lovenox)
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
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.
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
- Gender
Both
- Mininum Age
40 Years
- Maximum Age
N/A
- Healthy Volunteers
No
Resources
Source: Lehigh Valley Hospital
Authority: United States: Institutional Review Board
Locations
-
Lehigh Valley Hospital Muhlenberg
Bethlehem
Pennsylvania
18017
United States
Officials
Robert Kruklitis, MD (Principal Investigator, Lehigh Valley Hospital)
Sponsors
Lehigh Valley Hospital (Lead Sponsor)
GlaxoSmithKline (Collaborator)
References
None.
Links
None.
- Date Verified
- July 1st, 2011
- First Received
- July 8th, 2011
- Last Changed
- July 8th, 2011
Information obtained from ClinicalTrials.gov on July 11, 2011. Link to the current ClinicalTrials.gov record.
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