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

This study has been terminated.
(Study stopped due to lack of accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00521885
First received: August 24, 2007
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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 Intervention
Venous Thrombosis
Drug: fondaparinux

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
Official Title: Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients

Resource links provided by NLM:


Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Bleeding rate study day 1-14 (minor vs major) with 30 day f/u [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • DVT study day 1-14 (confirmed by LE ultra-sonogram) with 30 day f/u [ Time Frame: 45 Days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A2 Drug: fondaparinux
fondaparinux 2.5mg qd, enoxaparin 40mg qd
Other Name: Arixtra vs Lovenox

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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Robert Kruklitis, MD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00521885     History of Changes
Other Study ID Numbers: LVH IRB# 2-20070508
Study First Received: August 24, 2007
Last Updated: September 18, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 16, 2014