CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 target
Drug / intervention
Blake Drains (Blake drain, Ethicon USA) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00684125
NCT00684125N/ACompleted

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

Montreal Heart Institute·interventional·Posted May 26, 2008·Updated Jul 22, 2011

In Brief

A clinical study evaluating Blake Drains (Blake drain, Ethicon USA) and Standard mediastinal drainage for Pericardial Effusion and 2 related conditions. Completed, enrolled 150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsJohnson & Johnson

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 26, 2008
Enrollment StartJun 1, 2008
Primary CompletionMay 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.1 years ago

Interventions

Blake Drains (Blake drain, Ethicon USA)device

19F Blake drain located in the posterior pericardial cavity

Standard mediastinal drainagedevice

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