Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass
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: Fresh Autologous whole Blood, Standard of Care Expectant management of bleeding.
- Кому может быть актуально
- Состояния в реестре: Cardiac Disease, Bleeding Postoperative. Базовые параметры: 18 лет — 90 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
Targeted Fresh Autologous Whole Blood Transfusion After Cardiopulmonary Bypass: a Prospective Randomized Controlled Trial.
Обзор
Autologous blood transfused at the end of cardiopulmonary bypass will reduce total blood loss 24 hours after surgery and improve mitochondrial oxygen delivery measured by plasma succinate levels. The study design is a prospective randomized interventional trial of transfusion of fresh autologous whole blood versus standard of care expectant management of bleeding during elective cardiac surgery.
Подробное описание
Cardiac surgery carries a significant risk of bleeding requiring transfusion of stored blood products and blood transfusion associated with cardiac surgery consumes 20% of the blood supply worldwide. Although transfusion may be life-saving, significant risks of complications such as lung injury or even an increase in mortality are associated with transfusion. Decreasing transfusion requirements during cardiac surgery has the potential to reduce the rate of complications, improve patient outcomes, and reduce cost resulting in increased value for both the patient and the health system as a whole. Collection of autologous blood before cardiopulmonary bypass (CPB) for transfusion after CPB has been shown to be both safe and effective for reducing blood loss during cardiac surgery, but this intervention has not been targeted to a patient population at high risk for bleeding and transfusion. Fresh whole blood has the capacity to restore coagulation system function during profound coagulopathy in a trauma setting or following massive transfusion by an unknown mechanism. One unit of fresh whole blood is able to restore clotting function equivalent to that achieved by 10 units of pooled platelets. Autologous whole blood collection prior to CPB for transfusion post-operatively has been shown to improve coagulation and decrease clot lysis but is not routinely performed because 90% to 95% of patients do not have extensive blood loss and subsequent coagulopathy. Coupling accurate pre-operative bleeding risk prediction with autologous fresh whole blood collection for transfusion after CPB would target an established, low cost, low risk intervention to an at risk patient population who may experience significant benefit.
Вмешательства
- Другое Fresh Autologous whole Blood
Subjects randomized this arm will receive fresh autologous whole blood - Другое Standard of Care Expectant management of bleeding
the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
Первичные конечные точки
- Estimated Blood Loss [Срок оценки: Within 24 hours after surgery]
Вторичные конечные точки (12)
- Number of allogenic transfusions given [Срок оценки: 31 days]
- Severity of peri-operative stroke [Срок оценки: 31 days]
- Incident of peri-operative stroke [Срок оценки: 31 days]
- Development of Post-operative delirium [Срок оценки: 31 days]
- Development of Myocardial Infarction [Срок оценки: 31 days]
- Development of Heart failure [Срок оценки: 31 days]
- Detection of New Onset Atrial fibrillation [Срок оценки: 31 days]
- Development of Lung injury [Срок оценки: 31 days]
- Time to extubation [Срок оценки: 31 days]
- Development of Acute Kidney Injury [Срок оценки: 31 days]
- Initiation of renal replacement therapy [Срок оценки: 31 days]
- ICU length of stay [Срок оценки: 31 days]
Критерии участия
Критерии включения
- Adult subjects aged 18 to 90
- Able to provide informed consent
- Willing to accept autologous or allogenic blood transfusion
- Scheduled for elective cardiac surgery with cardiopulmonary bypass
Критерии исключения
- Pre-operative administration of allogenic blood bank products in the previous 3 months
- Hemodynamically unstable defined as a systolic blood pressure less than 90 mmHg with a heart rate greater 100 or requiring intravenous vasopressor medications
- Significant active infection or sepsis defined by positive blood culture or positive wound culture
- Hemoglobin less than 7 g/dl
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Colorado Hospital — Aurora
Идентификаторы
NCT: NCT03204357 · 16-2647