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

University of Montreal

Status: Completed

Conditions: Pericardial Effusion; Late Cardiac Tamponade; Surgical Reintervention

Treatments: Device: Standard mediastinal drainage; Device: Blake Drains (Blake drain, Ethicon USA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00684125

ICM 07-934

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Experimental group

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.

Treatment:

Device: Blake Drains (Blake drain, Ethicon USA)

2

Active Comparator group

Description:

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

Treatment:

Device: Standard mediastinal drainage