Pulmonary Embolism Clinical Trial
Official title:
A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily With Respect to Preventing VTE After Bariatric Surgery in Obese Patients
This pilot study is designed to determine the feasibility of conducting a randomized clinical trial comparing fondaparinux sodium (Arixtra) once daily with enoxaparin (Lovenox®) twice daily with respect to preventing deep vein thrombosis (DVT) and pulmonary embolism (PE) after bariatric surgery in obese patients.
In order to determine the feasibility of such a trial we need to determine the necessary
sample size. In order to determine the necessary sample size, we need to obtain estimates of
the incidence of DVT and the prevalence of PE using MRV in each treatment group. Descriptive
statistics and 95% confidence intervals will be calculated to determine the incidence of DVT
and the prevalence of PE using MRV in obese patients who have received treatment to prevent
DVT and PE associated with bariatric surgery.
Anti-factor Xa levels will be used to help determine if treatments are reaching appropriate
levels.
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