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Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

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ClinicalTrials.gov Identifier: NCT01457586
Recruitment Status : Unknown
Verified October 2011 by Roberto Rocha e Silva, Hospital Pitangueiras.
Recruitment status was:  Recruiting
First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Heart Diseases Biological: Blood transfusion Biological: No blood transfusion Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011

Keywords provided by Roberto Rocha e Silva, Hospital Pitangueiras:
Heart Surgery
Blood Transfusion
Postoperative Complications

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases