Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Recruitment status was: Recruiting
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.
|Heart Diseases||Biological: Blood transfusion Biological: No blood transfusion||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery|
- Any postoperative complication [ Time Frame: 1 month ]Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Transfusion
Patient who received blood transfusion in the perioperative period
Biological: Blood transfusion
Blood transfusion in perioperative period.
No Intervention: No Transfusion
Patients who did not receive blood transfusion in the perioperative period
Biological: No blood transfusion
No transfusion in the perioperative period.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457586
|Contact: ROBERTO R Silva, MD PHDfirstname.lastname@example.org|
|Jundiai, Sao Paulo, Brazil, 1295|
|Contact: Ricardo De Mola, MD 55-11-45276226 email@example.com|
|Sub-Investigator: Ricardo De Mola, MD|
|Principal Investigator:||ROBERTO R Silva, MD PHD||Hospital Pitangueiras|