The goal of this observational study is to evaluate how blood donors' lifestyle and nutritional status influence the quality of packed red blood cells (pRBCs) during storage and their impact on patient safety in transfused neonates and postpartum women. The main questions it aims to answer are: 1. Are donor lifestyle and nutritional profiles associated with the development of storage lesions in pRBCs? 2. Do these donor-related factors influence clinical outcomes after transfusion in neonates and postpartum women? 3. Are storage lesion in pRBCs associated with clinical outcomes in transfused neonates and postpartum women? Researchers will compare pRBC units stratified according to donor lifestyle and nutritional profiles to determine differences in storage lesion biomarkers and post-transfusion clinical outcomes.
Lifestyle and nutritional status of blood donors impact the quality of packed red blood cells (pRBCs) during storage and influence patient safety. Our study proposes a prospective cohort to profile pRBCs based on blood donors' lifestyle and nutritional assessments. We will use causal and statistical models to associate these profiles with storage lesions and adverse clinical outcomes in transfused neonates and postpartum women.
Study Type
OBSERVATIONAL
Enrollment
1,014
Instituto Nacional de Perinatología
Mexico City, Mexico City, Mexico
Antioxidant capacity in stored blood units
Quantification of total antioxidant capacity, including hydrophilic and lipophilic antioxidants (vitamins, proteins, lipids, glutathione, and uric acid), reflecting the ability to neutralize free radicals. Unit of Measure: mmol (Trolox equivalents)
Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)
Oxidative damage in stored blood units
Measurement of lipid peroxidation products, including malondialdehyde (MDA), quantified as thiobarbituric acid reactive substances (TBARS) using colorimetric assays. Unit of Measure: µM MDA
Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)
Red blood cell membrane changes
Assessment of erythrocyte membrane integrity based on phosphatidylserine externalization, quantified by flow cytometry. Percentage of phosphatidylserine-positive cells (%)
Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)
Hemolysis in stored blood units
Determination of hemolysis as the percentage of free hemoglobin in the supernatant, quantified using HemoCue Plasma/Low Hb system. Unit of Measure: % hemolysis
Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)
Patient safety
Occurrence of transfusion-related adverse events, including multiorgan dysfunction, infections, hemolytic reactions, transfusion-associated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), length of hospital stay (days), and all-cause mortality.
Time frame: Within the first 24 hours post-transfusion and throughout hospitalization
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