ICU Cell Saver to Reduce Blood Transfusions in Cardiac

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2009

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Control
    • Traditional Chest drains
  • Experimental: CARDIOPAT
    • CARDIOPAT Cell Saver after Surgery

Clinical Trial Outcome Measures

Primary Measures

  • Number of Transfusions per patient
    • Time Frame: 10 days after surgery

Secondary Measures

  • Mortality
    • Time Frame: 30 days after surgery

Participating in This Clinical Trial

Inclusion Criteria

  • All patients presenting for cardiac Surgery Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardiochirurgia E.H.
  • Provider of Information About this Clinical Study
    • Saverio Nardella, Cardiochirurgia E.H.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.