Anaemia
Conditions
Keywords
central venous saturation, transfusion, critically ill, ICU, red blood cell
Brief summary
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).
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMeasurement of central venous saturation
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.
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient in medical/surgical/trauma ICU * Hemoglobin level between 7g/dl and 9g/dl * Written informed consent by patient or next of kin * Hemodynamically stable: * CRT normal * Serum lactate \<2 mmol/l * MAP \>65 mmHg * noradrenalin \< 0,2 mcg/kg/min and no increase in 6 hours * No new ischemic change on ECG * Monitored with CVC, arterial catheter, hourly urine output * Respiratorily stable * No support or * Nasal canula/face mask O2 supplementation or * NIV or * Invasive mechanical ventillation: PC/VC/PS, PEEP\< 15 cmH2O FiO2 \< 50% and no increase in 6 hours * PiCCO or expert ECHO available within 48hours
Exclusion criteria
* 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) * Pregnancy * Active bleeding * Neurotrauma requiring intracranial pressure monitoring * Morbid obesity BMI \>40 * Horowitz Quotient (paO2/FiO2) \< 200 * Acute and chronic liver failure (Child-Pugh B,C) * Fever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of units of red blood cells transfused per patient | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Change in central venous saturation (ScvO2) posttransfusion | 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 |
Countries
Hungary
Contacts
CONTACTNikolett Kiss, Dr
CONTACTZsolt Molnar, Professor
STUDY_CHAIRMarton Papp, Dr
Semmelweis University
STUDY_CHAIRCaner Turan, Dr
Semmelweis University
STUDY_CHAIRDilan Mark Karim, Dr
Semmelweis University
STUDY_CHAIRLaszlo Zubek, Dr
Semmelweis University
Outcome results
None listed