Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients
Tracking Information | |||||
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First Received Date ICMJE | June 27, 2007 | ||||
Last Updated Date | September 27, 2012 | ||||
Start Date ICMJE | July 2007 | ||||
Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Bleeding events [ Time Frame: inpatient hospitalization ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Bleeding events [ Time Frame: inpatient hospitalization ] | ||||
Change History | Complete list of historical versions of study NCT00493896 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Development of thrombocytopenia [ Time Frame: inpatient hospitalization ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Development of thrombocytopenia [ Time Frame: inpatient hospitalization ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients | ||||
Official Title ICMJE | Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol | ||||
Brief Summary | This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. |
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Detailed Description | This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, & platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary & secondary diagnoses, central venous access, and sequential compression device utilization. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
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Condition ICMJE | Venous Thromboembolism | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 27 | ||||
Completion Date | April 2010 | ||||
Primary Completion Date | April 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 89 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00493896 | ||||
Other Study ID Numbers ICMJE | 107696 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Eastern Virginia Medical School | ||||
Study Sponsor ICMJE | Eastern Virginia Medical School | ||||
Collaborators ICMJE | GlaxoSmithKline | ||||
Investigators ICMJE |
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Information Provided By | Eastern Virginia Medical School | ||||
Verification Date | September 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |