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Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Heart Diseases Clinical Trial

Official title:
Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Clinical Trial Summary

Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.

Blood transfusion might be only a marker of the patient severity.

Clinical Trial Description

Criteria for blood transfusion during extra corporeal circulation (if used) is volume expansion need leading to a predictable hematocrit lower than 25%.

Criteria for blood transfusion after extra corporeal circulation or in the postoperative period is a hematocrit below 30% with signs of low cardiac output due to hypovolemia. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01457586
Study type Interventional
Source Hospital Pitangueiras
Contact ROBERTO R Silva, MD PHD
Phone 55-11-45215757
Email rochaesilva@incor.usp.br
Status Recruiting
Phase Phase 4
Start date September 2011
Completion date October 2013
View Details
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