NCT00950547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 5, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

July 30, 2009

Last Update Submit

January 4, 2010

Conditions

Blood TransfusionCardiac Surgery

Keywords

Blood TransfusionCell SaverCardiac SurgeryEvaluate the efficacy of cell salvage CardioPAT routinely used in cardiac surgery in reducing blood transfusions.

Outcome Measures

Primary Outcomes (1)

  • Number of Transfusions per patient

    10 days after surgery

Secondary Outcomes (1)

  • Mortality

    30 days after surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Traditional Chest drains

Device: Traditional Chest Drains

CARDIOPAT

EXPERIMENTAL

CARDIOPAT Cell Saver after Surgery

Device: CARDIOPAT

Interventions

CARDIOPATDEVICE

Cell Saver System at bedside for ICU stay

CARDIOPAT
Traditional Chest DrainsDEVICE

Chest drains as usual with no possibility to reinfuse lost blood

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting for cardiac Surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiochirurgia European Hospital

Rome, 00152, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

January 5, 2010

Record last verified: 2010-01

Locations

IT(1)