ICU Cell Saver to Reduce Blood Transfusions in Cardiac

Not Applicable

Completed

• Conditions: Blood Transfusion; Cardiac Surgery
• Interventions: Device: Traditional Chest Drains; Device: CARDIOPAT

• Registration Number: NCT00950547
• Lead Sponsor: Cardiochirurgia E.H.

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 available

Study Timeline

• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Study Start: 2009-08
• Primary Completion: 2009-12
• Status Verified: 2010-01
• Study Completion: 2010-01
• Last Update Submitted: 2010-01-04
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• All patients presenting for cardiac Surgery

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Traditional Chest Drains	Traditional Chest drains
CARDIOPAT	CARDIOPAT	CARDIOPAT Cell Saver after Surgery

Primary Outcome Measures

Name	Time	Method
Number of Transfusions per patient	10 days after surgery

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days after surgery

Trial Locations

Locations (1)

Cardiochirurgia European Hospital; 🇮🇹 Rome, Italy