Blood Donation, Blood Transfusion
Conditions
Keywords
Blood Transfusion, Storage Lesions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Instituto Nacional de Perinatologia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Eligible candidates according to Mexican regulatory standards for blood donation (NOM-253-SSA1-2012)
Exclusion criteria
\- Refusal to provide specific informed consent for participation in the research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant capacity in stored blood units | From donation (baseline) to transfusion or end of storage (up to 42 days) | 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) |
| Oxidative damage in stored blood units | From donation (baseline) to transfusion or end of storage (up to 42 days) | Measurement of lipid peroxidation products, including malondialdehyde (MDA), quantified as thiobarbituric acid reactive substances (TBARS) using colorimetric assays. Unit of Measure: µM MDA |
| Red blood cell membrane changes | From donation (baseline) to transfusion or end of storage (up to 42 days) | Assessment of erythrocyte membrane integrity based on phosphatidylserine externalization, quantified by flow cytometry. Percentage of phosphatidylserine-positive cells (%) |
| Hemolysis in stored blood units | From donation (baseline) to transfusion or end of storage (up to 42 days) | Determination of hemolysis as the percentage of free hemoglobin in the supernatant, quantified using HemoCue Plasma/Low Hb system. Unit of Measure: % hemolysis |
| Patient safety | Within the first 24 hours post-transfusion and throughout hospitalization | 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. |
Countries
Mexico
Outcome results
None listed