Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
|ClinicalTrials.gov Identifier: NCT01457586|
Recruitment Status : Unknown
Verified October 2011 by Roberto Rocha e Silva, Hospital Pitangueiras.
Recruitment status was: Recruiting
First Posted : October 24, 2011
Last Update Posted : October 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases||Biological: Blood transfusion Biological: No blood transfusion||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||October 2013|
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.
- Any postoperative complication [ Time Frame: 1 month ]Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|