Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Phase 4

• Conditions: Heart Diseases
• Interventions: Biological: Blood transfusion; Biological: No blood transfusion

• 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.

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-21
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-24
• Last Update Posted: 2011-10-24
• Primary Completion: 2013-09
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transfusion	Blood transfusion	Patient who received blood transfusion in the perioperative period
No Transfusion	No blood transfusion	Patients who did not receive blood transfusion in the perioperative period

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.

Trial Locations

Locations (1)

Hospital Pitangueiras; 🇧🇷 Jundiai, Sao Paulo, Brazil