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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized RBCT | Experimental | Requires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. If O2ER < 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER < 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory |
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| Control group | Active Comparator | Requires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb ≤ 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized red blood cell transfusion strategy | Other | Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury (AKI) | Primary outcome will be the incidence of AKI, according to KDIGO latest definitions | 7-day after study inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 90-day mortality | 90-day after study inclusion | |
| proportion of patients undergoing RBCT, despite adequate/low O2ER | Patients receiving RBCT with O2ER<30% | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Erasme | Not yet recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39532348 | Derived | Fogagnolo A, Azzolina D, Taccone FS, Pedarzani E, Pasa G, Marianello D, Valpiani G, Marchesini C, Annoni F, Moureau A, Volta CA, Franchi F, Spadaro S. Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. BMJ Open. 2024 Nov 12;14(11):e089910. doi: 10.1136/bmjopen-2024-089910. |
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To be shared under reasonable requests.
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| European guidelines red blood cell transfusion strategy | Other | RBCT according to ESICM guidelines |
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| SOFA score variations | SOFA score at study inclusion-SOFA score at day 5 | 5 days |
| variations in myocardial-specific troponin | variations in myocardial-specific troponin | 24 hours after study inclusion |
| days on vasopressors | number of days on vasopressor therapy | 28 days |
| Major Adverse Kidney Events by 90 days (MAKE90) | composite of death, new renal replacement therapy, or persistent renal dysfunction | 90 days |
| ICU mortality | ICU mortality | through study completion, an average of 180 days |
| In-hospital mortality | In-hospital mortality | through study completion, an average of 180 days |
| Università di Ferrara | Recruiting | Ferrara | Ferrara | 44121 | Italy |
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| Università di Perugia | Recruiting | Perugia | Italy | 06121 | Italy |
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| Anestesia e Rianimazione Cardio-Toraco-Vascolare | Recruiting | Siena | Italy |
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