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| Tracking Information | |||||||||
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| First Received Date ICMJE | October 28, 2005 | ||||||||
| Last Updated Date | July 31, 2009 | ||||||||
| Start Date ICMJE | March 2006 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
comparison of the evolution between day 1 and day 14 of the mean echocardiographic score of pericardial effusion between treated and untreated (placebo) groups | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00247052 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion | ||||||||
| Official Title ICMJE | the Post Operative Pericardial Effusion (POPE) Treatment Study | ||||||||
| Brief Summary | The aim of the sudy is to evaluate, through clinical, biological and transthoracic echocardiography follow up, the evolution of post operative (cardiac surgery) pericardial effusion and mostly to evaluate the efficiency of a non steroidal anti inflammatory (NSAID) drug (diclofenac)for this indication. |
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| Detailed Description | Following cardiac surgery, the incidence of Pericardial effusion (PE) is high (50-85%) . The risk of tamponade is well acknowledged : about 2%. We published in 2004 in CHEST a study which allows us to know the natural history of post-operative PE and to validate, for the first time the use of an echocardiographic classification for predicting the occurrence of a tamponade. NSAID are widely used in this setting, but no study has ever been conducted trying to assess their efficiency. The aim of the study is therefore obvious : must we use NSAID in order to prevent post operative cardiac tamponades ?. In order to answer this question, we are going to conduct a double-blind randomized study comparing diclofenac to a placebo. Every patient hospitalized in a post operative cardiac rehabilitation center less than 30 days after cardiac surgery and presenting at the first TTE (Trans Thoracic cardiac Echography) a PE of severity > 2 (that is to say about 10 % of the totality of the patients having undergone a cardiac operation) will be included.: after randomisation, patients will receive a placebo or diclofenac (50 mg ) bid, in a double blind way, during 14 days. Trans thoracic cardiac echography, creatininemia, haemoglobinemia, International Normalized Ratio (for patients receiving a vitamin K antagonist) will be performed once a week during 2 weeks. Clinical assessment will be done every day (there will be no outpatient Primary end point : evolution of the mean echocardiographic score in each group -Secondary end-points : Number of tamponades Number of patients in whom the individual echographic grade is decreasing of at least one point Number of pericardiotomy Creatininemia Haemoglobinemia PE evolution in patients having an inflammatory syndrome (C reactive Protein >30) PE evolution in patients receiving a vitamin K antagonist 86 patients per group are necessary; therefore we will include a total of 200 patients |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Pericardial Effusion | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | Active Comparator: diclofenac | ||||||||
| Publications * | Meurin P, Weber H, Renaud N, Larrazet F, Tabet JY, Demolis P, Ben Driss A. Evolution of the postoperative pericardial effusion after day 15: the problem of the late tamponade. Chest. 2004 Jun;125(6):2182-7. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Completion Date | February 2009 | ||||||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00247052 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 2003-06 | ||||||||
| Study Sponsor ICMJE | French Cardiology Society | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | French Cardiology Society | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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