Routinely Use of CardioPAT Cell Saver in Cardiac Surgery: A Prospective Randomized Study Focused on Allogenic Blood Transfusion and Clinical Outcome
| Registry | NCT00950547 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 350 (Actual) |
| Sponsor | Cardiochirurgia E.H. (Other) |
| Conditions | Blood Transfusion, Cardiac Surgery |
| Interventions | CARDIOPAT, Traditional Chest Drains (Device) |
| Dates | start 2009-08-01, primary completion 2009-12-01, completion 2010-01-01, first posted 2009-07-31, last updated 2010-01-05 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Blood Transfusion All trials for Cardiac Surgery All trials of CARDIOPAT All trials of Traditional Chest Drains
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control | Active comparator | Device: Traditional Chest Drains | Traditional Chest drains |
| CARDIOPAT | Experimental | Device: CARDIOPAT | CARDIOPAT Cell Saver after Surgery |
Sex: All
Inclusion Criteria: * All patients presenting for cardiac Surgery Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| Cardiochirurgia European Hospital | Rome | Italy |