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ICU Cell Saver to Reduce Blood Transfusions in Cardiac

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00950547
First Posted: July 31, 2009
Last Update Posted: January 5, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cardiochirurgia E.H.
  Purpose

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.


Condition Intervention
Blood Transfusion Cardiac Surgery Device: CARDIOPAT Device: Traditional Chest Drains

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome

Resource links provided by NLM:


Further study details as provided by Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Number of Transfusions per patient [ Time Frame: 10 days after surgery ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days after surgery ]

Enrollment: 350
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Traditional Chest drains
Device: Traditional Chest Drains
Chest drains as usual with no possibility to reinfuse lost blood
Experimental: CARDIOPAT
CARDIOPAT Cell Saver after Surgery
Device: CARDIOPAT
Cell Saver System at bedside for ICU stay

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients presenting for cardiac Surgery

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950547


Locations
Italy
Cardiochirurgia European Hospital
Rome, Italy, 00152
Sponsors and Collaborators
Cardiochirurgia E.H.
  More Information

Responsible Party: Saverio Nardella, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT00950547     History of Changes
Other Study ID Numbers: 00-02
First Submitted: July 30, 2009
First Posted: July 31, 2009
Last Update Posted: January 5, 2010
Last Verified: January 2010

Keywords provided by Cardiochirurgia E.H.:
Blood Transfusion
Cell Saver
Cardiac Surgery
Evaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery in reducing blood transfusions.