Status:
WITHDRAWN
Is Using Fondaparinux (Blood Thinner) to Treat Lung Clot Cheaper Than Traditional Therapy
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 for...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older who present with acute symptomatic pulmonary embolism and who require antithrombotic therapy
- Diagnostic confirmation based on the following criteria
- intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography
- a high-probability ventilation-perfusion lung scan, or a nondiagnostic lung scan with documentation of deep-vein thrombosis, either by compression ultrasonography or by venography.
- Primary outpatient MD of record is an SMDC MD or patient did not have an outpatient MD when this event occurred.
- For the matched control (UFH) cohort only: unfractionated heparin utilized for initial antithrombotic therapy. (LMWH use is allowed initially in the fondaparinux arm.) Patient willingness to have fondaparinux injections administered as an outpatient by themselves, family members, or other caregivers.
Exclusion
- Patients will be ineligible for the study if they had received therapeutic doses of UFH or LMWH or oral anticoagulants for more than 24 hours;
- Patient required thrombolysis, embolectomy, or a vena cava filter;
- Anticoagulant therapy was contraindicated - for example, because of active bleeding or thrombocytopenia (a platelet count below 100,000 per cubic millimeter).
- Patients are ineligible if they had an estimated creatinine clearance \< 30 mL/min.
- Uncontrolled hypertension (systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg);
- Pregnancy
- Physician has estimated the life expectancy to be less than three months.
- Patients weighing \> 150 kg
- Indwelling epidural catheter
- Inability to give informed consent
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00377091
Start Date
June 1 2007
End Date
November 1 2007
Last Update
May 30 2013
Active Locations (1)
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1
St. Mary's Medical Center
Duluth, Minnesota, United States, 55805