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

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.

Study Overview

• Status: Terminated
• Conditions: Venous Thrombosis
• Intervention / Treatment: Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily; Drug: Lovenox 40mg SC Daily

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
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18017
      • Lehigh Valley Hospital Muhlenberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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 Names: fondaparinux
Active Comparator: 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 Names: enoxaparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u	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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deep Vein Thrombosis	Confirmed by Lower Extremity Ultra-sonogram	14 Days

Collaborators and Investigators

• Sponsor: Lehigh Valley Hospital
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Robert Kruklitis, MD, LeHigh Valley Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: August 24, 2007
• First Submitted That Met QC Criteria: August 27, 2007
• First Posted (Estimate): August 28, 2007

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Bleeding rates; Prophylaxis for deep vein thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Enoxaparin; Fondaparinux
• Other Study ID Numbers: LVH IRB# 2-20070508