Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|