Red Blood Cell Transfusion Decision Based on Arterial-venous Oxygen Difference Can Reduce Mortality in Critically Ill Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 177
- Locations
- 1
- Primary Endpoint
- 90-day mortality
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hemoglobin level <10 g/dL during the first 72 hours of ICU
Exclusion Criteria
- •Acute bleeding
- •Hemoglobin level less than 7 g/dL
Outcomes
Primary Outcomes
90-day mortality
Time Frame: after 90 days from study enrollment
mortality
Secondary Outcomes
- Length of ICU stay(from ICU admission to discharge, up to 8 weeks)
- Variation in Sequential Organ Failure Assessment (SOFA) score(5 days)
- Days of vasopressor(28 days after study inclusion)
- Acute kidney injury(7 days after study inclusion)
Investigators
Alberto Fogagnolo
Principal investigator
Università degli Studi di Ferrara