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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 24, 2007 | ||||||||
| Last Updated Date | July 8, 2008 | ||||||||
| Start Date ICMJE | September 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Bleeding rate study day 1-14 (minor vs major) with 30 day f/u [ Time Frame: 45 days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Bleeding rate study day 1-14 (minor vs major) with 30 day f/u [ Time Frame: 45 days ] | ||||||||
| Change History | Complete list of historical versions of study NCT00521885 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
DVT study day 1-14 (confirmed by LE ultra-sonogram) with 30 day f/u [ Time Frame: 45 Days ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
DVT study day 1-14 (confirmed by LE ultra-sonogram) with 30 day f/u [ Time Frame: 45 Days ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients | ||||||||
| Official Title ICMJE | Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-Surgical Patients | ||||||||
| 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. |
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| 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). |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Venous Thrombosis | ||||||||
| Intervention ICMJE | Drug: fondaparinux | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | September 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 40 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00521885 | ||||||||
| Responsible Party | Robert Kruklitis, MD, Lehigh Valley Hospital | ||||||||
| Study ID Numbers ICMJE | LVH IRB# 2-20070508 | ||||||||
| Study Sponsor ICMJE | Lehigh Valley Hospital | ||||||||
| Collaborators ICMJE | GlaxoSmithKline | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lehigh Valley Hospital | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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