Clinical trial NCT01457586: Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Official title: Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Diseases
Keywords: Heart Surgery
Blood Transfusion
Postoperative Complications
Lead sponsor: Hospital Pitangueiras
Sponsor class: OTHER
First posted: 2011-10-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients who received blood transfusion previous to the heart surgery.

Primary outcomes:
measure: Any postoperative complication
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Jundiai
country: Brazil
facility: Hospital Pitangueiras
state: Sao Paulo
Study officials:
affiliation: Hospital Pitangueiras
name: ROBERTO R Silva, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Hung M, Besser M, Sharples LD, Nair SK, Klein AA. The prevalence and association with transfusion, intensive care unit stay and mortality of pre-operative anaemia in a cohort of cardiac surgery patients. Anaesthesia. 2011 Sep;66(9):812-8. doi: 10.1111/j.1365-2044.2011.06819.x. Epub 2011 Jul 25.
citation: Dardashti A, Ederoth P, Algotsson L, Bronden B, Luhrs C, Bjursten H. Blood transfusion after cardiac surgery: is it the patient or the transfusion that carries the risk? Acta Anaesthesiol Scand. 2011 Sep;55(8):952-61. doi: 10.1111/j.1399-6576.2011.02445.x. Epub 2011 May 16.