Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07558369

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Blood Donation Blood Transfusion

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Perinatología

Mexico City, 11000, Mexico

Location contact

Edgar Barrientos-Galeana, MSc

CONTACT

[email protected]

52 55 5520 9900 ext. 315

Edgar Barrientos-Galeana, MSc

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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

  3. 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 (%)

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Perinatologia

Other Gov

Registry information

Official study title

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

Acronym: ESENCIA

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.