This clinical trial aims to personalise red blood cell transfusion strategies in the crtitically ill patients. The amount of transfusions needs to be minimised in order to prevent adverse events and organ dysfunctions linked to high amounts of red blood cell transfusions. The researchers aim to investigate the efficacy and safety of measuring the central venous oxygen saturation (ScvO2) (oxygen content in a venous blood sample taken from a central line) to guide clinicians if transfusion is necessary. The researchers aim to compare the ScvO2 guided transfusion strategy with transfusion based on the clinician's judgment (taking into consideration the patients' comorbidities and actual vital parameters).
Red blood cell transfusions are routine practice in the management of critically ill patients; 25% of patients treated in the intensive care unit receive a transfusion. Its aim is to restore adequate oxygen delivery to peripheral tissues. Transfusion has numerous potentially harmful effects and significantly increases healthcare costs. International guidelines recommend a restrictive transfusion policy. These recommendations are based on studies that use the hemoglobin level as a transfusion trigger. Hemoglobin level does not provide sufficient information about the balance between oxygen delivery and oxygen consumption, which determines tissue oxygenation. Incorporating a physiological parameter into the transfusion decision-making algorithm may ensure a personalized transfusion strategy. Clear evidence is lacking regarding the usefulness of physiological transfusion triggers in the treatment of anemia in critically ill patients. Case reports and retrospective studies have been published, but no randomized trials have been conducted. Central venous oxygen saturation (ScvO₂) reflects the balance between oxygen delivery and consumption; its normal physiological range is 70-75%, and a decrease indicates inadequate oxygen delivery and oxygen supply/demand imbalance. Thus, it may serve as a potential physiological trigger for clinicians in personalized transfusion management of hemodynamically stable intensive care patients. Therefore our aim is to examine the efficacy and safety of an ScvO₂-guided transfusion trigger compared with clinician decision-based transfusion in critically ill patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
600
After randomisation central venous saturation will be measured. If the central venous saturation is below 70%, 1 unit of red blood cells will be transfused. The central venous saturation will be measured post transfusion, and if it is still below 70%, further 1 unit of RBCs will be transfused. Measurements and transfusions continue until ScvO2 reaches 70% or hemoglobin level increases above 9g/dl. If ScvO2 is above 70%, no transfusion will be administered. ScvO2 will be measured again between 4-12 hours after the initial measurement. If it is still above 70%, no transfusion will be administered, and no further measurement will be performed on the given day.
Semmelweis University, Department of Intensive Therapy
Budapest, Hungary
North-Pest Central Hospital- Hungarian Defense Forces Medical Center, Department of Anaesthesiology and Intensive Therapy
Budapest, Hungary
Number of units of red blood cells transfused per patient
Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months
Change in central venous saturation (ScvO2) posttransfusion
Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months
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