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Набор скоро начнётся NCT07543965

Cohort of Repeat Donor Experiences (CORE) Study

— Наблюдательное Health Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Plasmapheresis Procedure.
Кому может быть актуально
Состояния в реестре: Health Effects (Ferritin Levels, CRP Levels, iGg Levels, Self-reported Health). Базовые параметры: 18 лет — 74 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Associations Between Frequent Plasmapheresis, Biomarkers, and Health Outcomes: A 2-Year National Prospective Cohort Study

Обзор

The Plasma Protein Therapeutics Association (PPTA) sponsors the Cohort of Repeat Donor Experiences (CORE) Study. This is a prospective, observational cohort study that will follow Source Plasma donors for up to 2 years during the main study (anticipated to begin in summer 2026) and up to 3 months during the pilot launching in mid-March 2026. This study aims to confirm a lack of negative health effects Source Plasma donors may experience as a result of frequent plasmapheresis. The study will use data obtained through self-report surveys for the duration of the study along with periodic whole blood sample collections to test for CRP, ferritin, and IgG.

Подробное описание

The study employs a two-phase prospective design: (1) data collected before and 48-72 hours after an initial plasma Data will be collected through electronic surveys, real-time illness reports, biomarker analyses, and extracts of Blood Establishment Computer Software (BECS) records including donor screening and operational collection processing variables, if available. Study staff (Study Coordinators employed by the plasma collection companies and Westat central study staff) will engage with participants directly and Westat systems will be used for data collection. The pilot study is planned to occur prior to the main study, planned for early 2026, which will validate the feasibility of study methods and generate preliminary data toward the study aims. The pilot study will involve recruitment and enrollment of 50-90 participants at 2 donor centers for a three-month follow-up period. Pilot study participants will follow the main protocol study procedures, with the addition of brief feedback questions about their participant experience and the omission of End of Year Surveys, due to the shorter follow-up time.

Вмешательства

  • Процедура Plasmapheresis Procedure
    Both pilot and main cohort will undergo plasmapheresis (plasma donation) as part of their initial visit for the study. Some participants will donate plasma throughout the duration of either cohort (3 months in pilot or up to 2 years in the main study.

Первичные конечные точки

  • Biomarkers [Срок оценки: Baseline and every 8 weeks up to 24 months]
  • Short-Term Effects [Срок оценки: Baseline and 48 hours following baseline]
Вторичные конечные точки (2)
  • Cumulative Health [Срок оценки: Baseline and every 4 weeks up to 24 months]
  • Donation Practices [Срок оценки: Baseline through withdrawal]

Критерии участия

Критерии включения

  • Aged 18-74;
  • Meet health and medical history requirements for being a plasma donor per eCFR::21 CFR 630.10 Subpart B -- General donor eligibility requirements;
  • Willing to provide phone number and mailing address; has access to internet-enabled smartphone device;
  • Plans to remain within local area during study duration; has not donated whole blood within past 12 months;
  • Does not have permanent deferral;
  • Has not donated plasma more than once at a non-participating plasma center;
  • Another member of their household is not enrolled.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • ADMA Biocenters — Dallas

Идентификаторы

NCT: NCT07543965 · 96955

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗