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Sponsors and Collaborators: |
Montreal Heart Institute Johnson & Johnson |
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Information provided by: | Montreal Heart Institute |
ClinicalTrials.gov Identifier: | NCT00684125 |
The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. A prospective randomized trial.
Condition | Intervention |
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Pericardial Effusion Late Cardiac Tamponade Surgical Reintervention |
Device: Blake Drains (Blake drain, Ethicon USA) Device: Standard mediastinal drainage |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial |
Estimated Enrollment: | 150 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity.
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Device: Blake Drains (Blake drain, Ethicon USA)
19F Blake drain located in the posterior pericardial cavity
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2: Active Comparator
mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.
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Device: Standard mediastinal drainage
Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
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The incidence of pericardial effusion and late cardiac tamponade after aortic and valvular surgery is higher than after other cardiac surgical procedures. The aim of this study is to evaluate the clinical safety and efficacy of prolonged mediastinal drainage using small, soft silastic drains (Blake drain, Ethicon USA) versus conventional mediastinal drainage using large chest tubes. Patients undergoing aortic and / or valvular surgery will be randomized in two groups. In group A, mediastinal drainage will be accomplished using a 28F or 32F chest tube in the anterior mediastinum and a 19F Blake drain located in the posterior pericardial cavity. In group B, mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum. In both groups, conventional chest tubes will be removed on the first postoperative day, while patients in the group A will have prolonged drainage using the Blake drain until output is less than 50 ml over 24 hour. Patients will be followed during their postoperative course for occurrence of significant pericardial effusion as detected on routine echocardiogram and late cardiac tamponade requiring reintervention.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Geneviève Morin, BSc, RTT | 514-376-3330 ext 3725 | Genevieve.Morin@icm-mhi.org |
Contact: Sophie Robichaud, RTT CCRP | 514-376-3330 ext 3725 | Sophie.Robichaud@icm-mhi.org |
Canada, Quebec | |
Montreal Heart Institute | |
Montreal, Quebec, Canada, H1T 1C8 |
Principal Investigator: | Phillippe Demers, MD | Montreal Heart Institute |
Responsible Party: | Montreal Heart Institute - Cardiac surgeon ( Philippe Demers M.D., M.Sc., FRCSC ) |
Study ID Numbers: | ICM 07-934 |
Study First Received: | May 21, 2008 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00684125 |
Health Authority: | Canada: Health Canada |
late cardiac tamponade |
Heart Diseases Pericardial Effusion Cardiac Tamponade |
Cardiovascular Diseases |