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Sponsors and Collaborators: |
University of Minnesota GlaxoSmithKline |
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Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00377091 |
This study compares two blood thinners which are both accepted standard cares, fondaparinux and unfractionated heparin (UFH). These drugs are used to prevent the growth of existing blood clots and formation of additional blood clots in patients with pulmonary embolism (a blood clot in the lung) as they are beginning to take warfarin (another standard care blood thinner). Patients will be invited to participate because they have been diagnosed with a pulmonary embolism, require anticoagulation therapy (treatment with a blood thinner), and are currently hospitalized.
The purpose of this study is to determine if patients treated with fondaparinux will have shorter hospital stays and lower costs of treatment while in the hospital than similar patients receiving a different standard care with UFH. Fondaparinux is already approved by the FDA for use in patients with pulmonary embolism, for both inpatient and outpatient care, as long as treatment is begun with warfarin while they are hospitalized. It is therefore not an experimental treatment. The study is being conducted to determine which FDA approved treatment is the best practice for hospital treatment of pulmonary embolism. The study will also examine the safety and effectiveness of fondaparinux in local use.
Condition | Intervention | Phase |
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Pulmonary Embolism |
Drug: Fondaparinux |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Pharmacoeconomic Evaluation of Fondaparinux Treatment of Pulmonary Embolism (PE) Compared to Treatment With Unfractionated Heparin |
Estimated Enrollment: | 60 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | November 2007 |
Research Question
This study is being conducted to determine if treatment of pulmonary embolism (PE) with fondaparinux will decrease the length of stay and hospital costs of therapy while maintaining safety and efficacy, when compared to unfractionated heparin (UFH). Primary research questions: Determine if PE treatment utilizing fondaparinux will reduce the inpatient length of stay (LOS) and costs of hospital care to St. Mary's Duluth Clinic Health System (SMDC), when compared to a matched group of patients treated with UFH as standard care, during the same time period. Secondary research questions: Determine if bleeding and recurrent thrombosis rates are similar between the fondaparinux cohort and the UFH matched control group.
Specific Aims
4a. repeat venous thromboembolism events (VTE) 4b. bleeding events
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Diagnostic confirmation based on the following criteria
Exclusion Criteria:
United States, Minnesota | |
St. Mary's Medical Center | |
Duluth, Minnesota, United States, 55805 |
Principal Investigator: | Michael P. Gulseth, Pharm. D. | University of Minnesota |
Study ID Numbers: | 0510M76771 |
Study First Received: | September 13, 2006 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00377091 |
Health Authority: | United States: Institutional Review Board |
pulmonary embolism venous thromboembolism pharmacoeconomic heparin unfractionated heparin |
fondaparinux length of stay costs bleeding thrombosis |
Pulmonary Embolism Heparin, Low-Molecular-Weight Vascular Diseases Fondaparinux Venous Thromboembolism Hemorrhage Thrombosis Thromboembolism |
Org 31540 Calcium heparin Embolism and Thrombosis Respiratory Tract Diseases Embolism Lung Diseases Heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |