Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hospital Pitangueiras.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Roberto Rocha e Silva, Hospital Pitangueiras
ClinicalTrials.gov Identifier:
NCT01457586
First received: October 19, 2011
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Heart Diseases
Biological: Blood transfusion
Biological: No blood transfusion
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Resource links provided by NLM:


Further study details as provided by Hospital Pitangueiras:

Primary Outcome Measures:
  • Any postoperative complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transfusion
Patient who received blood transfusion in the perioperative period
Biological: Blood transfusion
Blood transfusion in perioperative period.
No Intervention: No Transfusion
Patients who did not receive blood transfusion in the perioperative period
Biological: No blood transfusion
No transfusion in the perioperative period.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457586

Contacts
Contact: ROBERTO R Silva, MD PHD 55-11-45215757 rochaesilva@incor.usp.br

Locations
Brazil
Hospital Pitangueiras Recruiting
Jundiai, Sao Paulo, Brazil, 1295
Contact: Ricardo De Mola, MD    55-11-45276226    ricardo_485@terra.com.br   
Sub-Investigator: Ricardo De Mola, MD         
Sponsors and Collaborators
Hospital Pitangueiras
Investigators
Principal Investigator: ROBERTO R Silva, MD PHD Hospital Pitangueiras
  More Information

Publications:

Responsible Party: Roberto Rocha e Silva, MD PHD in Cardiac Surgery, Hospital Pitangueiras
ClinicalTrials.gov Identifier: NCT01457586     History of Changes
Other Study ID Numbers: Heart surgery hemoderivatives
Study First Received: October 19, 2011
Last Updated: October 21, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital Pitangueiras:
Heart Surgery
Blood Transfusion
Postoperative Complications

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014