Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-64
SponsorInstituto Nacional de Perinatologia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eligible candidates according to Mexican regulatory standards for blood donation (NOM-253-SSA1-2012)
Disqualifiers
None
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Antioxidant capacity in stored blood units
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)
Time frame
From donation (baseline) to transfusion or end of storage (up to 42 days)2
Oxidative damage in stored blood units
Measurement of lipid peroxidation products, including malondialdehyde (MDA), quantified as thiobarbituric acid reactive substances (TBARS) using colorimetric assays. Unit of Measure: µM MDA
Time frame
From donation (baseline) to transfusion or end of storage (up to 42 days)3
Red blood cell membrane changes
Assessment of erythrocyte membrane integrity based on phosphatidylserine externalization, quantified by flow cytometry. Percentage of phosphatidylserine-positive cells (%)
Time frame
From donation (baseline) to transfusion or end of storage (up to 42 days)4
Hemolysis in stored blood units
Determination of hemolysis as the percentage of free hemoglobin in the supernatant, quantified using HemoCue Plasma/Low Hb system. Unit of Measure: % hemolysis
Time frame
From donation (baseline) to transfusion or end of storage (up to 42 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: