ICU Cell Saver to Reduce Blood Transfusions in Cardiac

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950547
• Other study ID #: 00-02
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: January 4, 2010
• Start date: August 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presenting for cardiac Surgery

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Transfusion
• Cardiac Surgery

Intervention

Device:
• CARDIOPAT
Cell Saver System at bedside for ICU stay
• Traditional Chest Drains
Chest drains as usual with no possibility to reinfuse lost blood

Locations

Country	Name	City	State
Italy	Cardiochirurgia European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Transfusions per patient		10 days after surgery	No
Secondary	Mortality		30 days after surgery	Yes