Cochicine Treatment for Post- Operative Pericardial Effusion

Summary

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.

Timeline

Start

2011-04

Primary completion

2013-03

Completion

2014-01

Publications

• Meurin P, Lelay-Kubas S, Pierre B, Pereira H, Pavy B, Iliou MC, Bussiere JL, Weber H, Beugin JP, Farrokhi T, Bellemain-Appaix A, Briota L, Tabet JY; French Society of Cardiology. Colchicine for postoperative pericardial effusion: a multicentre, double-blind, randomised controlled trial. Heart. 2015 Nov;101(21):1711-6. doi: 10.1136/heartjnl-2015-307827. Epub 2015 Jun 15.

Drugs

Indications