TRACS STUDY: Transfusion Requirements After Cardiac Surgery (TRACS)

November 27, 2009 updated by: Instituto do Coracao

Transfusion Requirements After Cardiac Surgery: a Randomized Controlled Clinical Trial (TRACS STUDY)

Blood transfusion is related to worse outcomes and the triggers for red blood cells transfusion are not well defined in cardiac surgery. Retrospective studies in cardiac surgery do not show benefits of red blood cell transfusion in reduction of morbidity and mortality in cardiac surgery. There are no prospective studies comparing outcomes between restrictive or liberal strategy in cardiac surgery.This study is a double-blind randomized study comparing clinical outcomes between two strategies of transfusion in cardiac surgery - liberal or restrictive.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Blood transfusion is commonly performed in patients submitted to cardiac surgery. However, there are many studies reporting adverse effects of this intervention and final data on benefits are not available. There are no prospective studies in cardiac surgery regarding red blood cell transfusions requirements. There are retrospective studies in cardiac surgery suggesting worse outcomes including higher rates of mortality in patients submitted to red blood transfusion. Hematocrit levels around 30% are usually recommended not evidence based. Our purpose is to prospectively evaluate two strategies of transfusion in 500 patients submitted to elective cardiac surgery: a liberal strategy - patients receive blood transfusion when hematocrit is lower than 30% since the intraoperative period until the ICU discharge; a restrictive strategy - patients receive blood transfusion only when hematocrit is lower than 24%.

Clinical outcomes, costs and quality of life will be compared.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403000
        • Recruiting
        • InCor - Faculdade de Medicina da Universidade de Sao Paulo
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ludhmila A Hajjar, MD
        • Sub-Investigator:
          • Filomena R Galas, MD, PhD
        • Sub-Investigator:
          • Rosana E Nakamura, MD
        • Sub-Investigator:
          • Carolina Silva, MD
        • Sub-Investigator:
          • Paulo C Bueno, MD
        • Sub-Investigator:
          • Roberto Kalil Filho, MD, PhD
        • Sub-Investigator:
          • Jean-Louis Vincent, MD, PhD
        • Sub-Investigator:
          • José Otávio C Auler Jr, MD, PHD
        • Sub-Investigator:
          • Thais Mauad, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All elective primary and redo adult cardiac surgical patients for coronary artery bypass grafting, valve procedure or combined procedures
  • Adults patients
  • Written informed consent

Exclusion Criteria:

  • Age less than 18 years
  • Transplant procedures
  • Emergency procedures
  • Aortic repairs
  • Congenital procedures
  • Previous anemia (hemoglobin lower than 10 g/dL)
  • Previous thrombocytopenia (platelet number lower than 100.000/mm3)
  • Previous known coagulopathy
  • Pregnancy
  • Those unable to receive blood transfusion
  • Patients who refused participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Liberal Transfusion Strategy
Liberal Group - transfusion when hematocrit is lower than 30%
Other: Red blood cell transfusion
Red blood cell (RBC) transfusion will be given when hematocrit fall below 30% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 30% or higher, no additional transfusion is necessary.
Other Names:
  • Red blood cells
  • Transfusion
  • Cardiac surgery
  • Liberal
Other: Red blood cell transfusion
Red blood cell (RBC) transfusion will be only given when hematocrit fall below 24% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 24% or higher, no additional transfusion is necessary.
Other Names:
  • Red blood cells
  • Transfusion
  • Cardiac surgery
  • Restrictive
Active Comparator: Restrictive Transfusion Strategy
Restrictive Group - transfusion when hematocrit is lower than 24%
Other: Red blood cell transfusion
Red blood cell (RBC) transfusion will be given when hematocrit fall below 30% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 30% or higher, no additional transfusion is necessary.
Other Names:
  • Red blood cells
  • Transfusion
  • Cardiac surgery
  • Liberal
Other: Red blood cell transfusion
Red blood cell (RBC) transfusion will be only given when hematocrit fall below 24% since intraoperative until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hematocrit is 24% or higher, no additional transfusion is necessary.
Other Names:
  • Red blood cells
  • Transfusion
  • Cardiac surgery
  • Restrictive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion
Time Frame: 30 days after surgery
30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
To compare length of stay in ICU, length of stay in Hospital, health-related quality of life, hospital costs and mortality between groups.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Coracao

Investigators

  • Principal Investigator: Ludhmila A Hajjar, MD, Incor - HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

November 30, 2009

Last Update Submitted That Met QC Criteria

November 27, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Transfusion

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Clinical Trials on Red blood cell transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe