Clinical Trials Logo
  1. Home
  2. Cardiac Surgery
  3. NCT01021631

TRACS STUDY: Transfusion Requirements After Cardiac Surgery — TRACS  

Cardiac Surgery Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01021631
Study type Interventional
Source Instituto do Coracao
Contact Ludhmila A Hajjar, MD
Phone 55-11-93194401
Email ludhmila@terra.com.br
Status Recruiting
Phase Phase 3
Start date February 2009
Completion date April 2010
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05054179 - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain Phase 2/Phase 3
Completed NCT04051021 - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients N/A
Recruiting NCT04604886 - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients N/A
Recruiting NCT04075981 - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF) Phase 3
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Recruiting NCT04709705 - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) Phase 2/Phase 3
Not yet recruiting NCT05563662 - SURgical Registry of ENDocarditis EuRope
Withdrawn NCT03289104 - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX N/A
Completed NCT02964026 - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients N/A
Completed NCT03563196 - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed NCT04199039 - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction N/A
Completed NCT02471001 - The Levels of Anaesthetics in Heart Muscle During Heart Surgery N/A
Completed NCT02325726 - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery. N/A
Completed NCT01246947 - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation N/A
Completed NCT01151254 - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation N/A
Completed NCT00996099 - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients N/A
Completed NCT00821262 - Sevoflurane in Cardiac Surgery Phase 4
Completed NCT00617955 - Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates N/A
Completed NCT00336466 - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS) Phase 2
Completed NCT00337805 - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery Phase 2/Phase 3