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

NCT07558369 | Not Yet Recruiting

• 1 other identifier: 2026-1-7
• Study Type: observational
• Target: 1,014
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are donor lifestyle and nutritional profiles associated with the development of storage lesions in pRBCs?
2. 2.Do these donor-related factors influence clinical outcomes after transfusion in neonates and postpartum women?
3. 3.Are storage lesion in pRBCs associated with clinical outcomes in transfused neonates and postpartum women?

Conditions

Blood Donation; Blood Transfusion

Keywords

Blood Transfusion; Storage Lesions

Outcome Measures

Primary Outcomes (5)

• 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)

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

• 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

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

• Red blood cell membrane changes

  Assessment of erythrocyte membrane integrity based on phosphatidylserine externalization, quantified by flow cytometry. Percentage of phosphatidylserine-positive cells (%)

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

• 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

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

• Patient safety

  Occurrence of transfusion-related adverse events, including multiorgan dysfunction, infections, hemolytic reactions, transfusion-associated circulatory overload (TACO), transfusion-related acute lung injury (TRALI), length of hospital stay (days), and all-cause mortality.

  Within the first 24 hours post-transfusion and throughout hospitalization

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

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

Sponsors & Collaborators

• Instituto Nacional de Perinatologia: lead

Study Sites (1)

Instituto Nacional de Perinatología

Mexico City, Mexico City, 11000, Mexico

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, serum, plasma, and hemolyzed samples from blood donors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

ME (1)