Cochicine Treatment for Post- Operative Pericardial Effusion

Overview

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.

Full Title of Study: “Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

Detailed Description

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.

Interventions

  • Drug: Colchicines
    • oral form, 1 mg, once a day during 14 days
  • Drug: Placebo
    • oral form, placebo

Arms, Groups and Cohorts

  • Experimental: Cochicine
    • Colchicine arm: patient receiving 1 mg per day for 14 days
  • Placebo Comparator: Placebo
    • patients placebo controlled

Clinical Trial Outcome Measures

Primary Measures

  • change in effusion grade
    • Time Frame: 14 days

Secondary Measures

  • frequency of late cardiac tamponade
    • Time Frame: 14 days
  • number of patients with at least a one-grade decrease in the effusion
    • Time Frame: 14 days
  • mean change in the width of the effusion measured in millimeters
    • Time Frame: 14 days
  • evolution of prespecified subgroups
    • Time Frame: 14 days
    • patients with inflammatory syndrom : crp > 30 mg/l patients receiving an anticoagulant patients with a post pericardiotomy syndrom

Participating in This Clinical Trial

Inclusion Criteria

  • patients with recent cardiac surgery – admitted for cardiac rehabilitation – pericardial effusion > grade 2 (corresponds to a loculated effusion > 10 millimeters or a circumferential effusion of any size)on the first trans thoracic echocardiography performed more than 7 days after surgery Exclusion Criteria:

  • patients who do not give written consent to participate – pregnancy – colchicine allergy; – renal failure, which we define as a serum creatinine level > 250micromol/l or clairance < 30 ml/mn – heart transplantation,or correction of congenital heart anomalies cardiac surgery more than 30 days before their first trans thoracic echocardiography pericardial effusion that requires immediate drainage.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • French Cardiology Society
  • Collaborator
    • French Federation of Cardiology
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe Meurin, MD, Principal Investigator, Clinique Les Grands Près – Villeneuve Saint Denis

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