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.
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
Mexico City
-
Mexico City、Mexico City、メキシコ、11000
- Instituto Nacional de Perinatología
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コンタクト：
- Edgar Barrientos-Galeana, MSc
- 電話番号：315 52 55 5520 9900
- メール：edb.galeana@hotmail.com
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主任研究者：
- Edgar Barrientos-Galeana, MSc
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Antioxidant capacity in stored blood units
時間枠：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
時間枠：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
時間枠：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)
|
|
Hemolysis in stored blood units
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2026-1-7 (その他の助成金/資金番号：Instituto Nacional de Perinatología)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。