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

Primary Purpose

Pericardial Effusion, Late Cardiac Tamponade, Surgical Reintervention

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Blake Drains (Blake drain, Ethicon USA)
Standard mediastinal drainage
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pericardial Effusion focused on measuring late cardiac tamponade

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.

Outcomes

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.

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.

Full Information

First Posted
May 21, 2008
Last Updated
July 21, 2011
Sponsor
Montreal Heart Institute
Collaborators
Johnson & Johnson
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1. Study Identification

Unique Protocol Identification Number
NCT00684125
Brief Title
Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery
Acronym
Blake
Official Title
Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Montreal Heart Institute
Collaborators
Johnson & Johnson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pericardial Effusion, Late Cardiac Tamponade, Surgical Reintervention
Keywords
late cardiac tamponade

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
mediastinal drainage will be accomplished using two 28F or 32F chest tubes located in the anterior mediastinum.
Intervention Type
Device
Intervention Name(s)
Blake Drains (Blake drain, Ethicon USA)
Other Intervention Name(s)
Blake drain: prolonged mediastinal drainage
Intervention Description
19F Blake drain located in the posterior pericardial cavity
Intervention Type
Device
Intervention Name(s)
Standard mediastinal drainage
Other Intervention Name(s)
mediastinal drainage
Intervention Description
Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillippe Demers, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16798298
Citation
Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049.
Results Reference
background
PubMed Identifier
16733162
Citation
Agati S, Mignosa C, Gitto P, Trimarchi ES, Ciccarello G, Salvo D, Trimarchi G. A method for chest drainage after pediatric cardiac surgery: a prospective randomized trial. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1306-9. doi: 10.1016/j.jtcvs.2006.02.013.
Results Reference
background
PubMed Identifier
15539727
Citation
Ege T, Tatli E, Canbaz S, Cikirikcioglu M, Sunar H, Ozalp B, Duran E. The importance of intrapericardial drain selection in cardiac surgery. Chest. 2004 Nov;126(5):1559-62. doi: 10.1378/chest.126.5.1559.
Results Reference
background
PubMed Identifier
11016389
Citation
Obney JA, Barnes MJ, Lisagor PG, Cohen DJ. A method for mediastinal drainage after cardiac procedures using small silastic drains. Ann Thorac Surg. 2000 Sep;70(3):1109-10. doi: 10.1016/s0003-4975(00)01800-2.
Results Reference
background
PubMed Identifier
12400760
Citation
Kuvin JT, Harati NA, Pandian NG, Bojar RM, Khabbaz KR. Postoperative cardiac tamponade in the modern surgical era. Ann Thorac Surg. 2002 Oct;74(4):1148-53. doi: 10.1016/s0003-4975(02)03837-7.
Results Reference
background
PubMed Identifier
16928545
Citation
Shah A, van den Brink A, de Mol B. Raised international normalized ratio: an early warning for a late cardiac tamponade? Ann Thorac Surg. 2006 Sep;82(3):1090-1. doi: 10.1016/j.athoracsur.2006.01.035.
Results Reference
background
PubMed Identifier
23575759
Citation
Moss E, Miller CS, Jensen H, Basmadjian A, Bouchard D, Carrier M, Perrault LP, Cartier R, Pellerin M, Demers P. A randomized trial of early versus delayed mediastinal drain removal after cardiac surgery using silastic and conventional tubes. Interact Cardiovasc Thorac Surg. 2013 Jul;17(1):110-5. doi: 10.1093/icvts/ivt123.
Results Reference
derived

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Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

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