Healia Clinical Trials Information Database

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

  • 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

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.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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