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Evaluation of Different Strategies of Pericardial Drainage After Aortic Valvular Surgery

NCT00684125 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2011-07-22

No results posted yet for this study

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.

Conditions

  • Pericardial Effusion
  • Late Cardiac Tamponade
  • Surgical Reintervention

Interventions

DEVICE

Blake Drains (Blake drain, Ethicon USA)

19F Blake drain located in the posterior pericardial cavity

DEVICE

Standard mediastinal drainage

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

Sponsors & Collaborators

Principal Investigators

  • Phillippe Demers, MD · Montreal Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2010-07-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00684125 on ClinicalTrials.gov