Pericardial Effusion Clinical Trial
Official title:
Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial
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.
Clinically insignificant pericardial effusion is common after heart surgery with an
incidence of 50 % to 85 % a few days after surgery Cardiac tamponade occurs in about 1-2 %
of patients who undergo cardiac surgery and may develop slowly without clear-cut clinical
signs. Most tamponade occurs more than 7 days after surgery which is a concern because, at
that time, patients often have already been discharged from the hospital.
No study has ever shown the efficacy any drug for this condition.In particular, we published
a study demonstrating the absence of efficacy of a non steroidal anti inflammatory drug
(Meurin P, Tabet JY, Thabut G, et al.French Society of Cardiology. Nonsteroidal
anti-inflammatory drug treatment for postoperative pericardial effusion: a multicenter
randomized, double-blind trial. Ann Intern Med. 2010 Feb2;152(3):137-43) Cochicine is widely
used to treat inflammatory pericarditis ; is it efficient to treat post operative
pericardial effusions ? this is the question we want to answer to.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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