Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457586

Enrollment

200

Registered

2011-10-24

Start date

2011-09-30

Completion date

2013-10-31

Last updated

2011-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Heart Surgery, Blood Transfusion, Postoperative Complications

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.

Interventions

BIOLOGICALBlood transfusion

Blood transfusion in perioperative period.

BIOLOGICALNo blood transfusion

No transfusion in the perioperative period.

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Any postoperative complication	1 month	Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.

Countries

Brazil

Contacts

Primary ContactROBERTO R Silva, MD PHD

rochaesilva@incor.usp.br55-11-45215757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026