Blood DonationESENCIANCT07558369
Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA)
An observational study of Blood Donation and Blood Transfusion, run by Instituto Nacional de Perinatologia at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Donation, Blood Transfusion
- How many people
- 1,014 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Eligible candidates according to Mexican regulatory standards for blood donation (NOM-253-SSA1-2012)
Who cannot join
- Refusal to provide specific informed consent for participation in the research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Instituto Nacional de Perinatología
Mexico City, Mexico City, 11000
Edgar Barrientos-Galeana, MSc, 52 55 5520 9900 ext. 315, edb.galeana@hotmail.com
Edgar Barrientos-Galeana, MSc
About this study
Official title: 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:
- Are donor lifestyle and nutritional profiles associated with the development of storage lesions in pRBCs?
- Do these donor-related factors influence clinical outcomes after transfusion in neonates and postpartum women?
- 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.
Read the 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.
- Conditions
- Blood Donation, Blood Transfusion
- Keywords
- Blood Transfusion, Storage Lesions
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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 (%)
Measured: 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
Measured: 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.
Measured: Within the first 24 hours post-transfusion and throughout hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DonationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,014 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, María Eugenia Flores Quijano, Instituto Nacional de Perinatologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558369
- Sponsor's protocol ID
- 2026-1-7
- Other IDs
- 2026-1-7
- Acronym
- ESENCIA
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle of Blood Donors and Its Impact on the Quality of Blood Components During Storage and Patient Safety
- ClinicalTrials.gov ID
- NCT07558369
- Acronym / sponsor ID
- ESENCIA / 2026-1-7
- Conditions
- Blood Donation, Blood Transfusion
- Keywords
- Blood Transfusion, Storage Lesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,014 participants (estimated)
- Lead sponsor
- Instituto Nacional de PerinatologiaOther government
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are donor lifestyle and nutritional profiles associated with the development of storage lesions in pRBCs?
- Do these donor-related factors influence clinical outcomes after transfusion in neonates and postpartum women?
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Eligible candidates according to Mexican regulatory standards for blood donation (NOM-253-SSA1-2012)
Key exclusion criteria (1 listed)
- Refusal to provide specific informed consent for participation in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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 (%)
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Instituto Nacional de Perinatología
Mexico City, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Donation and Blood Transfusion, run by Instituto Nacional de Perinatologia at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant capacity in stored blood units (time frame: From donation (baseline) to transfusion or end of storage (up to 42 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.