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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-1-7 | Other Grant/Funding Number | Instituto Nacional de Perinatología |
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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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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 (%) | 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 | 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. | Within the first 24 hours post-transfusion and throughout hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
- Refusal to provide specific informed consent for participation in the research
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The study population consists of candidates for whole blood donation at the Blood Bank (BDS) of the National Institute of Perinatology (INPer). All candidates must first complete standard Blood Bank procedures, including medical interview, complete blood count screening, blood collection, and infectious disease testing, in accordance with institutional protocols. Candidates deemed eligible for donation following routine evaluation will be invited to participate in the study.
Those who agree will provide study-specific informed consent. Participation involves additional assessments beyond standard Blood Bank procedures.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Perinatología | Mexico City | Mexico City | 11000 | Mexico |
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Blood, serum, plasma, and hemolyzed samples from blood donors