Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA) (ESENCIA)
Lifestyle of Blood Donors and Its Impact on the Quality of Blood Components During Storage and Patient Safety
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:
- Are donor lifestyle and nutritional profiles associated with the development of storage lesions in pRBCs?
- Do these donor-related factors influence clinical outcomes after transfusion in neonates and postpartum women?
- 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.
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Mexico City
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Mexico City, Mexico City, México, 11000
- Instituto Nacional de Perinatología
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Contato:
- Edgar Barrientos-Galeana, MSc
- Número de telefone: 315 52 55 5520 9900
- E-mail: edb.galeana@hotmail.com
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Investigador principal:
- Edgar Barrientos-Galeana, MSc
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Antioxidant capacity in stored blood units
Prazo: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Oxidative damage in stored blood units
Prazo: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Red blood cell membrane changes
Prazo: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Hemolysis in stored blood units
Prazo: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Patient safety
Prazo: Within the first 24 hours post-transfusion and throughout hospitalization
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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.
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Within the first 24 hours post-transfusion and throughout hospitalization
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2026-1-7 (Número de outro subsídio/financiamento: Instituto Nacional de Perinatología)
Informações sobre medicamentos e dispositivos, documentos de estudo
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