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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Lieux d'étude
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Mexico City
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Mexico City, Mexico City, Mexique, 11000
- Instituto Nacional de Perinatología
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Contact:
- Edgar Barrientos-Galeana, MSc
- Numéro de téléphone: 315 52 55 5520 9900
- E-mail: edb.galeana@hotmail.com
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Chercheur principal:
- Edgar Barrientos-Galeana, MSc
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
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.
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Antioxidant capacity in stored blood units
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2026-1-7 (Autre subvention/numéro de financement: Instituto Nacional de Perinatología)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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