Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
- Conditions
- Heart Diseases
- Registration Number
- NCT01457586
- Lead Sponsor
- Hospital Pitangueiras
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Patients with acquired heart disease with indication for surgery and 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.
- Patients who received blood transfusion previous to the heart surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Any postoperative complication 1 month Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital Pitangueiras
🇧🇷Jundiai, Sao Paulo, Brazil
Hospital Pitangueiras🇧🇷Jundiai, Sao Paulo, BrazilRicardo De Mola, MDSub Investigator