Cardiac Surgery Clinical Trial
Official title:
Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.
The goal of the clinical trial is to evaluate whether a restrictive transfusion strategy adjusted by SvO2 during the perioperative period of cardiac surgery may reduce the incidence of red blood cell transfusion. Adult patients operated on cardiac surgery will be randomly allocated into two groups, one receiving standard restrictive transfusion, the other receiving SvO2 adjusted restrictive transfusion.The proportion of patients transfused will be compared between the 2 groups.
Cardiac surgery represents only a small fraction of all surgical procedures, but consumes a significant proportion of the stored red blood cells (RBC), with almost 50% of patients receiving a perioperative transfusion. Since RBC transfusion is associated with an increased risk of morbidity and mortality, blood patient management strategy has been promoted to favour prevention of anaemia, reduction of bleeding and limitation of transfusion. Current guidelines recommend haemoglobin (Hb) threshold as low as 7 g/dL, but still with a wide possible range (7 to 9 g/dl) and suggest that Hb alone may not be the best criteria for triggering transfusion. As Hb is an oxygen carrier, the rationale for RBC transfusion should be to increase tissue oxygen delivery. Central venous oxygen saturation (central SvO2), which is related to the balance between tissue oxygen delivery and consumption, is easily measurable in cardiac surgery. In a previous study, the investigators showed that in anaemic patients having undergone cardiac surgery, restrictive transfusion according to central SvO2 allowed a significant reduction in RBC transfusion incidence in the ICU. The investigators hypothesize that a restrictive transfusion strategy adjusted by SvO2 during all the perioperative period of cardiac surgery may reduce further the incidence of RBC transfusion. Limiting RBC transfusion to patients with a low SvO2 could save unnecessary transfusions, without increasing the anaemia related risk. ;
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 |
NCT00821262 -
Sevoflurane in Cardiac Surgery
|
Phase 4 | |
Completed |
NCT00996099 -
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
|
N/A | |
Completed |
NCT00617955 -
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
|
N/A | |
Completed |
NCT00337805 -
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
|
Phase 2/Phase 3 | |
Completed |
NCT00336466 -
The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)
|
Phase 2 |