Donor Lifestyle and Nutritional Status, Blood Component Quality, and Patient Safety (ESENCIA) (ESENCIA)
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.
연구 개요
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Mexico City
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Mexico City, Mexico City, 멕시코, 11000
- Instituto Nacional de Perinatología
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연락하다:
- Edgar Barrientos-Galeana, MSc
- 전화번호: 315 52 55 5520 9900
- 이메일: edb.galeana@hotmail.com
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수석 연구원:
- Edgar Barrientos-Galeana, MSc
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Antioxidant capacity in stored blood units
기간: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Oxidative damage in stored blood units
기간: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Red blood cell membrane changes
기간: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Hemolysis in stored blood units
기간: From donation (baseline) to transfusion or end of storage (up to 42 days)
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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)
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Patient safety
기간: Within the first 24 hours post-transfusion and throughout hospitalization
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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.
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Within the first 24 hours post-transfusion and throughout hospitalization
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 2026-1-7 (기타 보조금/기금 번호: Instituto Nacional de Perinatología)
약물 및 장치 정보, 연구 문서
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