Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Hospital Pitangueiras

Status and phase: Unknown; Phase 4

Conditions: Heart Diseases

Treatments: Biological: No blood transfusion; Biological: Blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01457586

Heart surgery hemoderivatives

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Transfusion

Active Comparator group

Description:

Patient who received blood transfusion in the perioperative period

Treatment:

Biological: Blood transfusion

No Transfusion

No Intervention group

Description:

Patients who did not receive blood transfusion in the perioperative period

Treatment:

Biological: No blood transfusion