Impact of Microparticles in Blood on Transfused Patient Outcomes (IMIB)
Cell-derived Microparticles in Red Blood Cell (RBC) Concentrates, and Their Potential Impact on Outcomes of Transfused Patients in Critical Care: a Prospective Multicentre National Cohort Study of Patients Included in the ABLE Trial
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
During conservation of red blood cell concentrates, red blood cells (RBCs) undergo biochemical and morphological changes that have been well described, and are collectively termed " storage lesions ". The exact effects of these lesions in terms of beneficial or deleterious implications in the recipient remain to be elucidated. However, several retrospective studies in targeted populations suggest that an increase in the duration of RBC conservation could lead to an increase in morbidity and mortality in transfused patients. The multicenter, prospective trial ABLE (Age of Blood Evaluation, ISRCTN44878718) aimed to evaluate in a randomised clinical trial, the impact of the age of transfused RBC concentrates on several outcomes in critical care patients.
Among the modifications that RBCs undergo during storage, the generation of microparticles from red blood cellsRBCs or residual platelets present in the blood concentrate has never been evaluated in a prospective clinical study. It has been reported that the number of red cell-derived microparticles (RMPs) present in stored blood increases with storage duration. In vivo, microparticles MPs appear to be increasingly involved in disease processes, notably due to their pro-inflammatory and pro-coagulant effects. Furthermore, it has been shown that the antigens of the Rhesus group are expressed on the RBC derived microparticles, and the investigative team has shown that microparticles derived from elsewhere (endothelial cells) are capable of activating cells which are important in the induction of immune responses (dendritic cells). Thus, transfusing red blood cell derived microparticles could participate in post-transfusional alloimmunization which may also be evaluated in this study.
The aim of the IMIB study is to (1) quantify red cell- and platelet-derived microparticles MPs in RBC concentrates, and (2) evaluate the impact of the quantity of transfused microparticles (MPs) on survival and several outcomes in the patients enrolled in the ABLE trial in France.
Other aims are to investigate the relationship between the number of microparticles in RBC units and (1) the age of RBC, (2) donors characteristics, (3) the procedures used to prepare the blood products (to define a potential new "lesion storage" marker).
Тип исследования
Регистрация (Действительный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria are those of the ABLE trial: patients who
- Have had a request for a first red cell unit transfusion in the Intensive Care Unit (ICU), and
- Have an anticipated length of invasive and/or non-invasive continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) mechanical ventilation of at least 48 hours once enrolled, as estimated by the attending physician
Exclusion Criteria:
- less than 18 years of age
- previously enrolled in the ABLE study
- has already been transfused with red cells during the current hospitalisation
- has an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months
- has undergone routine cardiac surgical care
- decision to withdraw/withhold some critical care had been made
- brain dead
- no red cells with a storage time of 7 days or less available in the blood bank that cannot be transported from the blood supplier
- Who require more than 1 unit of uncross-matched red cells
- With a known objection to blood transfusions
- With autologous blood donations
- Who pose difficulties in securing blood products (rare blood groups), and who are difficult to match
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Transfused critical care patients
Patients included in the Age of BLood Evaluation (ABLE) trial in either arms and included in a French center.
|
Flow cytometric quantification of microparticles in transfused blood
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Все вызывают смертность
Временное ограничение: 90 дней
|
90 дней
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
All cause mortality
Временное ограничение: 28 days, 6 months
|
28 days, 6 months
|
|
|
Multi organ dysfunction score
Временное ограничение: 6 months
|
6 months
|
|
|
Nosocomial infection
Временное ограничение: 6 months
|
including Nosocomial pneumonia, Deep tissue infections (e.g.
peritonitis, mediastinitis), Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU
|
6 months
|
Другие показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Intensive care and Hospital duration of stay
Временное ограничение: 6 months
|
6 months
|
|
Length of time requiring respiratory, haemodynamic and renal support
Временное ограничение: 6 months
|
6 months
|
Соавторы и исследователи
Следователи
- Главный следователь: Francine Garnache-Ottou, PharmD, PhD, Etablissement Français du Sang, Besançon
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IMIB PHRC 2013
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
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Клинические исследования Критическая помощь
-
Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth...Активный, не рекрутирующийРычаг управления_Bolstered Care | Группа лечения_HIVRR+S+FL | Группа лечения_HIVRR+S+FLMУганда