Cardiopulmonary Bypass Induced Red Blood Cell Lysis
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: Blood and urine collection.
- Кому может быть актуально
- Состояния в реестре: Cardiopulmonary Bypass, Cardiac Surgery, Kidney Injury, Acute. Базовые параметры: 18 лет — 88 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
Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass
Обзор
Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.
Подробное описание
Cost estimates for brain, lung, cardiac, and kidney complications following complex cardiac surgeries that require a medical assist device to by-pass the heart and lungs (cardiopulmonary bypass, CPB) is estimated to cost $80 million per individual states in the US over a ten-year period. These extra costs represent a significant burden on the healthcare system but could be reduced by understanding how medical assist devices lead to organ injury associated with complex cardiac surgeries. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.
Вмешательства
- Другое Blood and urine collection
No intervention - Biological specimen collection
Первичные конечные точки
- Hemolysis [Срок оценки: Change from baseline at hour 1 during procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 2 during procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 3 during procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 4 during procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 4 post procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 2 post procedure]
- Hemolysis [Срок оценки: Change from baseline at hour 24 post procedure]
- Hemolysis [Срок оценки: Change from baseline on day 2 post procedure]
- Hemolysis [Срок оценки: Change from baseline on day 3 post procedure]
- Hemolysis [Срок оценки: Change from baseline on day 4 post procedure]
Вторичные конечные точки (10)
- Kidney injury [Срок оценки: Change from baseline at hour 1 during procedure]
- Kidney injury [Срок оценки: Change from baseline at hour 2 during procedure]
- Kidney injury [Срок оценки: Change from baseline at hour 3 during procedure]
- Kidney injury [Срок оценки: Change from baseline at hour 4 during procedure]
- Kidney injury [Срок оценки: Change from baseline at hour 2 post procedure]
- Kidney injury [Срок оценки: Change from baseline at hour 24 post procedure]
- Kidney injury [Срок оценки: Change from baseline at 2 days post procedure]
- Kidney injury [Срок оценки: Change from baseline at 3 days post procedure]
- Kidney injury [Срок оценки: Change from baseline at 4 days post procedure]
- Kidney injury [Срок оценки: Change from baseline at 5 days post procedure]
Критерии участия
Критерии включения
- Admitted to UMMC for cardiac procedure
- Age: >/=18 y.o TO 88 y.o.
- Undergoing CPB >1hr for the following surgeries (a) complex cardiac surgery (b) heart valve replacement surgery OR (c) CABG surgery.
Критерии исключения
- Pregnant
- Non English speaking
- Unable to consent or have Legally Authorized Representative (LAR) assent to study
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
- Center for Blood Oxygen Transport and Hemostasis — Baltimore
Идентификаторы
NCT: NCT05189262 · HP-00094849 · 1R01HL162120-01