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Cochicine Treatment for Post- Operative Pericardial Effusion

French Cardiology Society · 2011
ClinicalTrials.gov · Datasets · License: Public Domain · 2011
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cardiac-surgerycolchicine
Background: The incidence of asymptomatic pericardial effusion is high after cardiac surgery. Objective: To assess whether colchicine is effective in reducing post operative pericardial effusion volume. Design: Multicenter, randomized, double-blind, placebo-controlled study. Intervention : colchicine 1mg vs placebo, once daily for 14 days Setting :10 post operative cardiac rehabilitation centers. Patients: 200 patients at high risk of tamponade because of moderate to large persistent pericardial effusion (grade 2, 3 or 4 on a scale of 0 to 4 measured by echocardiography) more than 7 days after cardiac surgery. Measurements: The main end point will be change in effusion grade after 14 days of treatment. Secondary endpoints include frequency of late cardiac tamponade.
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