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ICU Cell Saver to Reduce Blood Transfusions in Cardiac

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.
 
ClinicalTrials.gov Identifier: NCT00950547
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
Cardiochirurgia E.H.

Tracking Information
First Submitted Date  ICMJE July 30, 2009
First Posted Date  ICMJE July 31, 2009
Last Update Posted Date January 5, 2010
Study Start Date  ICMJE August 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
Number of Transfusions per patient [ Time Frame: 10 days after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
Mortality [ Time Frame: 30 days after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ICU Cell Saver to Reduce Blood Transfusions in Cardiac
Official Title  ICMJE Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome
Brief Summary

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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Blood Transfusion
  • Cardiac Surgery
Intervention  ICMJE
  • Device: CARDIOPAT
    Cell Saver System at bedside for ICU stay
  • Device: Traditional Chest Drains
    Chest drains as usual with no possibility to reinfuse lost blood
Study Arms  ICMJE
  • Active Comparator: Control
    Traditional Chest drains
    Intervention: Device: Traditional Chest Drains
  • Experimental: CARDIOPAT
    CARDIOPAT Cell Saver after Surgery
    Intervention: Device: CARDIOPAT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2010)
350
Original Estimated Enrollment  ICMJE
 (submitted: July 30, 2009)
200
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients presenting for cardiac Surgery

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00950547
Other Study ID Numbers  ICMJE 00-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Saverio Nardella, Cardiochirurgia E.H.
Study Sponsor  ICMJE Cardiochirurgia E.H.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cardiochirurgia E.H.
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP