Oxygen Extraction-guided Transfusion in Critically Ill Patients
- Conditions
- Critical IllnessAnemia
- Registration Number
- NCT03767127
- Lead Sponsor
- Università degli Studi di Ferrara
- Brief Summary
Anemia is common in intensive care unit (ICU) patients and often appears early in the ICU course. The optimal management red blood cells RBC transfusion in critically ill patients remains controversial and clinical studies in this field have usually been based on transfusion thresholds. In the "TRICC" Trial, patients assigned to a restrictive transfusion strategy (transfusion if Hb\<7 g/dL) had similar mortality to patients transfused if Hb\<10 g/dL. Notably, none of the large RCT tried to focus on a personalize RBC transfusion protocol, i.e. a transfusion protocol which address the individual need for transfusion basing on physiological approach. We therefore hypothesized that patients with high extraction of oxygen could benefit more of RBCs transfusion regardless their hemoglobin levels.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 177
- Hemoglobin level <10 g/dL during the first 72 hours of ICU
- Acute bleeding
- Hemoglobin level less than 7 g/dL
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90-day mortality after 90 days from study enrollment mortality
- Secondary Outcome Measures
Name Time Method Length of ICU stay from ICU admission to discharge, up to 8 weeks Variation in Sequential Organ Failure Assessment (SOFA) score 5 days daily variation in SOFA score (0-24 points scale with higher values indicating worst conditions)
Days of vasopressor 28 days after study inclusion Need for vasopressor
Acute kidney injury 7 days after study inclusion Occurence of acute kidney injury according to KDIGO 2012 guidelines
Trial Locations
- Locations (1)
Università di Ferrara
🇮🇹Ferrara, Italy