Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients - Full Text View

Sponsor:	Lehigh Valley Hospital
Collaborator:	GlaxoSmithKline
Information provided by:	Lehigh Valley Hospital
ClinicalTrials.gov Identifier:	NCT00521885

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:

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: ORG 31540 Fondaparinux sodium Enoxaparin Sodium

U.S. FDA Resources

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

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:	July 8, 2011
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
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Enoxaparin

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 February 12, 2012