Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Blood Donation, Blood Transfusion. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lifestyle of Blood Donors and Its Impact on the Quality of Blood Components During Storage and Patient Safety
Overview
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.
Primary outcome measures
- Antioxidant capacity in stored blood units [Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)]
- Oxidative damage in stored blood units [Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)]
- Red blood cell membrane changes [Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)]
- Hemolysis in stored blood units [Time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)]
- Patient safety [Time frame: Within the first 24 hours post-transfusion and throughout hospitalization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Mexico · 1 center
- Instituto Nacional de Perinatología — Mexico City
Identifiers
NCT: NCT07558369 · 2026-1-7 · 2026-1-7