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Completed

NCT Number: NCT00684125

Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blake Drains (Blake drain, Ethicon USA)

Device

19F Blake drain located in the posterior pericardial cavity

Other names: Blake drain: prolonged mediastinal drainage

Standard mediastinal drainage

Device

Mediastinal drainage will be accomplished using 28F or 32F chest tube located in the anterior mediastinum

Other names: mediastinal drainage

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study title

Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery: A Prospective Randomized Trial

Acronym: Blake

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 26, 2008
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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