Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Pharmacoeconomic Evaluation of Fondaparinux Treatment of Pulmonary Embolism (PE) Compared to Treatment With Unfractionated Heparin|
- Primary endpoints: The primary end-points will be determining if the utilization of fondaparinux to treat PE in the inpatient setting will reduce length of stay and hospital treatment costs, when compared to a UFH matched control group.
- Secondary endpoints: The secondary end-points will be to determine if bleeding and recurrent thrombosis rates are similar between the fondaparinux cohort and the UFH matched control group.
|Study Start Date:||June 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
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.
- Enroll 30 St. Mary's Medical Center (SMMC, an affiliate of SMDC) patients into the treatment cohort, utilizing fondaparinux as their primary immediate antithrombin therapy, while warfarin is being titrated to therapeutic effect.
- Retrospectively identify a matched control group of 30 PE patients, treated with UFH as standard care, during the same period of time.
- Determine the LOS and costs of inpatient care on a standardized scale for both the treatment cohort and the control group.
- Perform a retrospective review of patients' medical records for the 3 months after the initial pulmonary embolism, to determine the rates of:
4a. repeat venous thromboembolism events (VTE) 4b. bleeding events
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377091
|United States, Minnesota|
|St. Mary's Medical Center|
|Duluth, Minnesota, United States, 55805|
|Principal Investigator:||Michael P. Gulseth, Pharm. D.||University of Minnesota - Clinical and Translational Science Institute|