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Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients (BRiEF)
This study is currently recruiting participants.
Study NCT00521885   Information provided by Lehigh Valley Hospital
First Received: August 24, 2007   Last Updated: July 8, 2008   History of Changes

August 24, 2007
July 8, 2008
September 2007
 
Bleeding rate study day 1-14 (minor vs major) with 30 day f/u [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]
Bleeding rate study day 1-14 (minor vs major) with 30 day f/u [ Time Frame: 45 days ]
Complete list of historical versions of study NCT00521885 on ClinicalTrials.gov Archive Site
DVT study day 1-14 (confirmed by LE ultra-sonogram) with 30 day f/u [ Time Frame: 45 Days ] [ Designated as safety issue: Yes ]
DVT study day 1-14 (confirmed by LE ultra-sonogram) with 30 day f/u [ Time Frame: 45 Days ]
 
Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients
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.

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).

 
Interventional
Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Venous Thrombosis
Drug: fondaparinux
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
50
September 2008
 

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
Both
40 Years and older
No
Contact: Sharon Kromer, RN, CCRC 610-402-1592 sharon.kromer@lvh.com
Contact: Dana Wentzel, RN,MSHSA, CCRC 610-402-0544 dana.wentzel@lvh.com
United States
 
NCT00521885
Robert Kruklitis, MD, Lehigh Valley Hospital
LVH IRB# 2-20070508
Lehigh Valley Hospital
GlaxoSmithKline
Principal Investigator: Robert Kruklitis, MD Lehigh Valley Hospital
Lehigh Valley Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP