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Sponsors and Collaborators: |
Lehigh Valley Hospital GlaxoSmithKline |
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Information provided by: | Lehigh Valley Hospital |
ClinicalTrials.gov Identifier: | NCT00521885 |
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 |
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Venous Thrombosis |
Drug: fondaparinux |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-Surgical Patients |
Estimated Enrollment: | 50 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
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A2: Active Comparator |
Drug: fondaparinux
fondaparinux 2.5mg qd, enoxaparin 40mg qd
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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).
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sharon Kromer, RN, CCRC | 610-402-1592 | sharon.kromer@lvh.com |
Contact: Dana Wentzel, RN,MSHSA, CCRC | 610-402-0544 | dana.wentzel@lvh.com |
United States, Pennsylvania | |
Lehigh Valley Hospital Muhlenberg | Recruiting |
bethlehem, Pennsylvania, United States, 18017 | |
Contact: Sharon Kromer, RN,CCRC 610-402-1592 sharon.kromer@lvh.com | |
Principal Investigator: Robert Kruklitis, MD |
Principal Investigator: | Robert Kruklitis, MD | Lehigh Valley Hospital |
Responsible Party: | Lehigh Valley Hospital ( Robert Kruklitis, MD ) |
Study ID Numbers: | LVH IRB# 2-20070508 |
Study First Received: | August 24, 2007 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00521885 |
Health Authority: | United States: Institutional Review Board |
Bleeding rates Prophylaxis for deep vein thrombosis |
Embolism and Thrombosis Embolism Vascular Diseases Fondaparinux Venous Thrombosis |
Hemorrhage Org 31540 Thrombosis Enoxaparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |