Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery (Blake)

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00684125
First received: May 21, 2008
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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
Pericardial Effusion
Late Cardiac Tamponade
Surgical Reintervention
Device: Blake Drains (Blake drain, Ethicon USA)
Device: Standard mediastinal drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Any pericardial effusion of 15 mm or more as measured on postoperative transthoracic echocardiogram on day 5 and late cardiac tamponade requiring surgical reintervention. [ Time Frame: Day 5 - post surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total volume of mediastinal drainage. Pain intensity on postoperative days 1 to 5. Incidence of postoperative atrial fibrillation Drain-associated infection or any other drain-associated adverse event. [ Time Frame: Days 1 or till discharge - post surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2008
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Device: Blake Drains (Blake drain, Ethicon USA)
19F Blake drain located in the posterior pericardial cavity
Other Name: Blake drain: prolonged mediastinal drainage
Active Comparator: 2
mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.
Device: Standard mediastinal drainage
Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
Other Name: mediastinal drainage

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 18 and 90 years old, undergoing either surgery of the ascending and/or transverse aorta, or surgery of the mitral and/or aortic valves
  • Availability for follow-up at the Montreal Heart Institute Exclusion criteria

Exclusion Criteria:

  • Emergency surgery
  • Unavailability for follow-up at the Montreal Heart Institute
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684125

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Montreal Heart Institute
Johnson & Johnson
Investigators
Principal Investigator: Phillippe Demers, MD Montreal Heart Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Philippe Demers M.D., M.Sc., FRCSC, Montreal Heart Institute - Cardiac surgeon
ClinicalTrials.gov Identifier: NCT00684125     History of Changes
Other Study ID Numbers: ICM 07-934
Study First Received: May 21, 2008
Last Updated: July 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Montreal Heart Institute:
late cardiac tamponade

Additional relevant MeSH terms:
Pericardial Effusion
Cardiac Tamponade
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014