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

April 23, 2026 updated by: María Eugenia Flores Quijano, Instituto Nacional de Perinatologia

Lifestyle of Blood Donors and Its Impact on the Quality of Blood Components During Storage and Patient Safety

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Lifestyle and nutritional status of blood donors impact the quality of packed red blood cells (pRBCs) during storage and influence patient safety. Our study proposes a prospective cohort to profile pRBCs based on blood donors' lifestyle and nutritional assessments. We will use causal and statistical models to associate these profiles with storage lesions and adverse clinical outcomes in transfused neonates and postpartum women.

Study Type

Observational

Enrollment (Estimated)

1014

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11000
        • Instituto Nacional de Perinatología
        • Contact:
        • Principal Investigator:
          • Edgar Barrientos-Galeana, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antioxidant capacity in stored blood units
Time Frame: From donation (baseline) to transfusion or end of storage (up to 42 days)

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

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Perinatologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-1-7 (Other Grant/Funding Number: Instituto Nacional de Perinatología)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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