Not Yet RecruitingNot Applicable

Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA)

Mexico1,014 participantsStarted 2026-07

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Antioxidant capacity in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Oxidative damage in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Red blood cell membrane changes

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Hemolysis in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Patient safety

Timeframe: Within the first 24 hours post-transfusion and throughout hospitalization

Trial details

NCT IDNCT07558369

SponsorInstituto Nacional de Perinatologia

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2028-07

View on ClinicalTrials.gov More Blood Donation trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Antioxidant capacity in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Oxidative damage in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Red blood cell membrane changes

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Hemolysis in stored blood units

Timeframe: From donation (baseline) to transfusion or end of storage (up to 42 days)

Patient safety

Timeframe: Within the first 24 hours post-transfusion and throughout hospitalization