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ICU Cell Saver to Reduce Blood Transfusions in Cardiac

This study has been completed.
Sponsor:
Information provided by:
Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT00950547
First received: July 30, 2009
Last updated: January 4, 2010
Last verified: January 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Number of Transfusions per patient [ Time Frame: 10 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients presenting for cardiac Surgery

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950547

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

No publications provided

Responsible Party: Saverio Nardella, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT00950547     History of Changes
Other Study ID Numbers: 00-02
Study First Received: July 30, 2009
Last Updated: January 4, 2010
Health Authority: Italy: Ministry of Health

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.

ClinicalTrials.gov processed this record on May 23, 2013