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Cochicine Treatment for Post- Operative Pericardial Effusion (POPE2)

Primary Purpose

Pericardial Effusion

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Colchicines
Placebo
Sponsored by
French Cardiology Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericardial Effusion focused on measuring Pericardial effusion, Cardiac surgery, Tamponade, colchicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bois Gibert
  • Centre Médical de Bligny
  • Clinique de Châtillon
  • Centre Dieulefit Santé
  • Hopital Corentin Celton
  • Clinique de la mitterie
  • Centre Hospitalier Loire Vendée Océan
  • Clinique Iris
  • Maison du mineur
  • Clinique les Grands Près

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cochicine

Placebo

Arm Description

Colchicine arm: patient receiving 1 mg per day for 14 days

patients placebo controlled

Outcomes

Primary Outcome Measures

change in effusion grade

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2010
Last Updated
January 13, 2014
Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT01266694
Brief Title
Cochicine Treatment for Post- Operative Pericardial Effusion
Acronym
POPE2
Official Title
Cochicine Treatment for Post- Operative Pericardial Effusion: The POPE 2 Study A Multicenter, Double-blind, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French Cardiology Society
Collaborators
French Federation of Cardiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion
Keywords
Pericardial effusion, Cardiac surgery, Tamponade, colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cochicine
Arm Type
Experimental
Arm Description
Colchicine arm: patient receiving 1 mg per day for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
patients placebo controlled
Intervention Type
Drug
Intervention Name(s)
Colchicines
Intervention Description
oral form, 1 mg, once a day during 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral form, placebo
Primary Outcome Measure Information:
Title
change in effusion grade
Time Frame
14 days
Secondary Outcome Measure Information:
Title
frequency of late cardiac tamponade
Time Frame
14 days
Title
number of patients with at least a one-grade decrease in the effusion
Time Frame
14 days
Title
mean change in the width of the effusion measured in millimeters
Time Frame
14 days
Title
evolution of prespecified subgroups
Description
patients with inflammatory syndrom : crp > 30 mg/l patients receiving an anticoagulant patients with a post pericardiotomy syndrom
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Meurin, MD
Organizational Affiliation
Clinique Les Grands Près - Villeneuve Saint Denis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bois Gibert
City
Ballan Miré
ZIP/Postal Code
37510
Country
France
Facility Name
Centre Médical de Bligny
City
Briis sous Forges
ZIP/Postal Code
91640
Country
France
Facility Name
Clinique de Châtillon
City
Châtillon
ZIP/Postal Code
92320
Country
France
Facility Name
Centre Dieulefit Santé
City
Dieulefit
ZIP/Postal Code
26220
Country
France
Facility Name
Hopital Corentin Celton
City
Issy les moulineaux
ZIP/Postal Code
92133
Country
France
Facility Name
Clinique de la mitterie
City
Lomme
ZIP/Postal Code
59160
Country
France
Facility Name
Centre Hospitalier Loire Vendée Océan
City
Machecoul
ZIP/Postal Code
44270
Country
France
Facility Name
Clinique Iris
City
Marcy l'étoile
ZIP/Postal Code
69280
Country
France
Facility Name
Maison du mineur
City
Vence
ZIP/Postal Code
06140
Country
France
Facility Name
Clinique les Grands Près
City
Villeneuve Saint Denis
ZIP/Postal Code
77174
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26076938
Citation
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.
Results Reference
derived

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Cochicine Treatment for Post- Operative Pericardial Effusion

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