ScvO2-Centered Optimisation of RED Blood Cell Transfusions
ConditionAnaemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient in medical/surgical/trauma ICU
Hemoglobin level between 7g/dl and 9g/dl
Written informed consent by patient or next of kin
CRT normal
Disqualifiers
ScvO2>80%
Acid-base imbalance (pH<7.3 or pH>7.5)
Chronic kidney disease (KDIGO Stage 3-4-5)
Acute heart failure (ESC 2021 definition)
Trial design
Design model
Parallel
Treatments tested in this trial
Measurement of central venous saturation
Diagnostic testAfter 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Central venous saturation guided transfusionExperimental treatment 1 intervention
Group B: Clinician's decision (without ScvO2)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 monthsOther outcomes
1
Length of vasopressor requirement
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 months2
Length of meachanical ventilation
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 months3
Incidence of end-organ failure
Newly developed end-organ dysfunction and failure i.e: bowel ischaemia, acute kindney injury, stroke, AMI
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 months4
Incidence of infective complications
Incidence of VAP, CLABSI, UTI, wound infection
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: