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

Starting soon

Conditions studied: Blood Donation, Blood Transfusion

In brief

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.

Key facts

Study ID

NCT07558369

Run by

Instituto Nacional de Perinatologia

People needed

1014

Starts

2026-07-01

Expected to finish

2029-07-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligible candidates according to Mexican regulatory standards for blood donation (NOM-253-SSA1-2012)

You may not qualify if…

• Refusal to provide specific informed consent for participation in the research

Where it is running

• Instituto Nacional de Perinatología — Mexico City, Mexico City, Mexico

Full record on ClinicalTrials.gov

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