Clinical Trial

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

Study acronym: ESENCIA
Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07558369
Lead Sponsor Instituto Nacional de Perinatologia
Conditions Blood Donation, Blood Transfusion
Enrollment 1,014 participants
Start Date 2026-07
Primary Completion 2028-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-30