Randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass
To evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. The study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the Brazilian Unified Health System (SUS). The patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. Continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. For categorical variables, the confidence interval will be calculated, conventionally set at 95%. For continuous variables, the T-test will be used to measure differences, while for categorical variables, the McNemar statistical test will be used. For all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
The surgical team will use a operative blood salvage system
Integral Medicine Institute Professor. Fernando Figueira-IMIP
Recife, Pernambuco, Brazil
RECRUITINGBlood transfusion rate
Reduction in the volume of packed red blood cells administered intrao peratively
Time frame: 2 days
Hospital mortality
Rate of Hospital mortality within 30 days
Time frame: 30 days
Hospital Stay
Number of Hospital stay in days
Time frame: 30 days
ICU stay
Number of ICU stay in days
Time frame: 30 days
Mechanical ventilation
Time of mechanical ventilation
Time frame: 30 days
Re-operation for bleeding
Rate of Re-operation for bleeding
Time frame: 30 days
Need for renal replacement therapy
Rate of Need for renal replacement therapy
Time frame: 30 days
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