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

• ClinicalTrials.gov Identifier: NCT00521885
• Recruitment Status: Terminated
• First Posted: August 28, 2007
• Results First Posted: November 1, 2017
• Last Update Posted: October 29, 2021
• Sponsor: Lehigh Valley Hospital
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): Lehigh Valley Hospital

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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

Contacts and Locations

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

• Responsible Party: Lehigh Valley Hospital
• ClinicalTrials.gov Identifier: NCT00521885
• Other Study ID Numbers: LVH IRB# 2-20070508
• First Posted: August 28, 2007
• Results First Posted: November 1, 2017
• Last Update Posted: October 29, 2021
• 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; Enoxaparin; Fondaparinux; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors