ICU Cell Saver to Reduce Blood Transfusions in Cardiac

NCT ID: NCT00950547

Last Updated: 2010-01-05

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

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-01-31

Brief Summary

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PURPOSE: Autotransfusion devices may be employed in cardiac surgery to decrease allogenic blood requirements. Limitations of previous trials include the use of cell saver systems in selected high risk patients only or the lack of blood transfusion-sparing strategies. The aim of this prospective randomized study is to evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery.

METHODS: The investigators will randomize 350 patients in two groups: group 1 receives a CardioPAT cell saver device (175 patients), group 2 doesn't receive any cell saver device. The incidence of allogenic blood transfusion and clinical outcome in both groups are evaluated.

Detailed Description

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Conditions

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Blood Transfusion Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Traditional Chest drains

Group Type ACTIVE_COMPARATOR

Traditional Chest Drains

Intervention Type DEVICE

Chest drains as usual with no possibility to reinfuse lost blood

CARDIOPAT

CARDIOPAT Cell Saver after Surgery

Group Type EXPERIMENTAL

CARDIOPAT

Intervention Type DEVICE

Cell Saver System at bedside for ICU stay

Interventions

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CARDIOPAT

Cell Saver System at bedside for ICU stay

Intervention Type DEVICE

Traditional Chest Drains

Chest drains as usual with no possibility to reinfuse lost blood

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients presenting for cardiac Surgery

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Cardiochirurgia E.H.

Locations

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Cardiochirurgia European Hospital

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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00-02

Identifier Type: -

Identifier Source: org_study_id

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