Trial Comparing Tisseel as an Adjunct to Traditional Hemostasis After Redo Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-02

Study Completion Date

2018-09-16

Brief Summary

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Bleeding after redo cardiac surgery is a common, unresolved and consequences-heavy event as per present day. Tisseel (Baxter inc) sprayed on the already hemostased mediastinum jut before closing seems a promising technique to radically diminish bleeding.

This study aims to verify this efficacy volume in chest drains) and possibly the consensual blood transfusion lessening.

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Detailed Description

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Conditions

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Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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TISSEEL

Spray Fibrin Sealant

Group Type EXPERIMENTAL

Spray Fibrin Sealant

Intervention Type PROCEDURE

Baxter Tisseel (Fibrin Sealant) is sprayed in the mediastinum at the end of the operation afetr routine chest hemostasis protocol has been completed, right before closing the chest.

CONTROL

Traditional hemostasis and chest closure routine

Group Type ACTIVE_COMPARATOR

Traditional Hemostasis and chest Closure Routine

Intervention Type PROCEDURE

Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)

Interventions

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Spray Fibrin Sealant

Baxter Tisseel (Fibrin Sealant) is sprayed in the mediastinum at the end of the operation afetr routine chest hemostasis protocol has been completed, right before closing the chest.

Intervention Type PROCEDURE