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OpenTrials
Completed

NCT Number: NCT00950547

ICU Cell Saver to Reduce Blood Transfusions in Cardiac

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.

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Key information

Conditions

Blood Transfusion Cardiac Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiochirurgia European Hospital

Rome, 00152, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting for cardiac Surgery

Exclusion criteria

  • None

Treatment and study plan

CARDIOPAT

Device

Cell Saver System at bedside for ICU stay

Traditional Chest Drains

Device

Chest drains as usual with no possibility to reinfuse lost blood

Primary outcomes

  1. Number of Transfusions per patient

    Time frame: 10 days after surgery

Secondary outcomes

  1. Mortality

    Time frame: 30 days after surgery

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 31, 2009
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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