Status:
COMPLETED
Non Steroidal Anti Inflammatory Treatment for Post Operative Pericardial Effusion
Lead Sponsor:
French Cardiology Society
Collaborating Sponsors:
CLIPA
Clinact
Conditions:
Pericardial Effusion
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 eval...
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...
Eligibility Criteria
Inclusion
- -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 \> or equal to 2 (that is to say loculated effusion \>10 millimeters or circumferential effusion \> 1 mm ) will be included
Exclusion
- Cardiac transplantation
- Age \<18 and \> 80
- Pregnancy
- Diclofenac contra indication (allergy, gastro intestinal ulcer, renal insufficiency, cardiac failure…)
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00247052
Start Date
March 1 2006
End Date
February 1 2009
Last Update
August 3 2009
Active Locations (5)
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1
Centre Hospitalier Chateau Lemoine
Bordeaux, France, 33000
2
Hôpital Bligny
Briis-sous-Forges, France, 91
3
IRIS
Lyon, France, 69
4
Hôpital Broussais
Paris, France, 75014