Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

NCT ID: NCT00684125

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Pericardial Effusion; Late Cardiac Tamponade; Surgical Reintervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Blake Drains (Blake drain, Ethicon USA)

Intervention Type: DEVICE

19F Blake drain located in the posterior pericardial cavity

2

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

Group Type: ACTIVE_COMPARATOR

Standard mediastinal drainage

Intervention Type: DEVICE

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

Interventions

Blake Drains (Blake drain, Ethicon USA)

19F Blake drain located in the posterior pericardial cavity

Intervention Type: DEVICE

Standard mediastinal drainage

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

Intervention Type: DEVICE

Other Intervention Names

Blake drain: prolonged mediastinal drainage; mediastinal drainage

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

Exclusion Criteria

• Emergency surgery
• Unavailability for follow-up at the Montreal Heart Institute

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Montreal Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Montreal Heart Institute - Cardiac surgeon

Principal Investigators

Phillippe Demers, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

References

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Reference Type: BACKGROUND

PMID: 16798298 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16733162 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15539727 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11016389 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12400760 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16928545 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23575759 (View on PubMed)

Other Identifiers

ICM 07-934

Identifier Type: -

Identifier Source: org_study_id