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

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ClinicalTrials.gov Identifier: NCT00521885
Recruitment Status : Terminated (Study stopped due to lack of accrual)
First Posted : August 28, 2007
Results First Posted : November 1, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Lehigh Valley Hospital

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.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily Drug: Lovenox 40mg SC Daily Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
Study Start Date : September 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arixtra (Fondaparinox) 2.5 mg SC Daily
Arixtra (Fondaparinox) 2.5 mg SC Daily
Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily
Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
Other Name: fondaparinux
Active Comparator: Lovenox 40mg SC Daily
Lovenox 40mg SC Daily
Drug: Lovenox 40mg SC Daily
Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
Other Name: enoxaparin



Primary Outcome Measures :
  1. Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u [ Time Frame: 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 :
  1. Deep Vein Thrombosis [ Time Frame: 14 Days ]
    Confirmed by Lower Extremity Ultra-sonogram



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00521885


Locations
United States, Pennsylvania
Lehigh Valley Hospital Muhlenberg
Bethlehem, Pennsylvania, United States, 18017
Sponsors and Collaborators
Lehigh Valley Hospital
GlaxoSmithKline
Investigators
Principal Investigator: Robert Kruklitis, MD Lehigh Valley Hospital

Responsible Party: Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00521885     History of Changes
Other Study ID Numbers: LVH IRB# 2-20070508
First Posted: August 28, 2007    Key Record Dates
Results First Posted: November 1, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Keywords provided by Lehigh Valley Hospital:
Bleeding rates
Prophylaxis for deep vein thrombosis

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Enoxaparin
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents