Blood Transfusion
Conditions
Brief summary
In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level \< 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients \[11\]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.
Interventions
OTHERIndividualized red blood cell transfusion strategy
Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.
OTHEREuropean guidelines red blood cell transfusion strategy
RBCT according to ESICM guidelines
Sponsors
Università degli Studi di Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis) * Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).
Exclusion criteria
* Age \< 18 years; * Pregnancy * Clinical evidence of acute bleeding * Diagnosis of haematological malignancy * Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs * Acquired or congenital disorders of coagulation * Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Kidney Injury (AKI) | 7-day after study inclusion | Primary outcome will be the incidence of AKI, according to KDIGO latest definitions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 90-day after study inclusion | — |
| proportion of patients undergoing RBCT, despite adequate/low O2ER | 28 days | Patients receiving RBCT with O2ER\<30% |
| SOFA score variations | 5 days | SOFA score at study inclusion-SOFA score at day 5 |
| variations in myocardial-specific troponin | 24 hours after study inclusion | variations in myocardial-specific troponin |
| days on vasopressors | 28 days | number of days on vasopressor therapy |
| Major Adverse Kidney Events by 90 days (MAKE90) | 90 days | composite of death, new renal replacement therapy, or persistent renal dysfunction |
| ICU mortality | through study completion, an average of 180 days | ICU mortality |
| In-hospital mortality | through study completion, an average of 180 days | In-hospital mortality |
Countries
Belgium, Italy
Outcome results
None listed