The Effect of Acute Normovolemic Hemodilution in Bone Tumor Surgery
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: acute normovolemic hemodilution.
- Кому может быть актуально
- Состояния в реестре: Acute Normovolemic Hemodilution, Bone Tumor, Goal-Directed Fluid Therapy, Transfusion. Базовые параметры: 18 лет — 75 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
- Китай
- 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
The Effect of Acute Normovolemic Hemodilution on Intraoperative Allogeneic Transfusion in Bone Tumor Surgery: a Prospective, Randomized Controlled Trial
Обзор
The prevention of intraoperative allogenetic blood transfusion has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone cancer surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. The HEAL trial will assess whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Подробное описание
Bone tumor surgery is associated with a significant risk of intraoperative blood loss and transfusion, with blood loss usually in the range of approximately 500-1000 ml and an average transfusion of up to 2 units of allogeneic red blood cell. The increase in allogeneic blood transfusion volume is an independent risk factor for postoperative complications in patients undergoing bone tumor surgery, as well as affecting the long-term survival rate of cancer patients.
Acute normovolemic hemodilution (ANH) is a patient blood management measure. The clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial. It is of great importance to explore the efficacy of ANH in bone cancer surgery patients.
Bone cancer surgery is an ideal setting to evaluate the efficacy of ANH, as the procedure is associated with high blood loss and infusion. The 'Hemodilution on intraoperative Allogeneic Transfusion' (HEAL) trial has been designed as a randomized, controlled trial to determine whether ANH will reduce the volume of intraoperative allogeneic red blood cell transfusion in patients undergoing bone cancer surgery.
Вмешательства
- Процедура acute normovolemic hemodilution
The ANH was conducted with more than 8 ml/kg of whole blood drawn from an internal jugular introducer by gravity and collected into standard sterile blood storage bags containing citrate phosphate-dextrose anticoagulant. The allowable blood loss was capped according to the preoperative hemoglobin, estimated blood volume, and the target hemoglobin (10 g/dL). The collected blood was simultaneously replaced by an equal volume of succinyl gelatin solution via at least one large bore peripheralvenous
Первичные конечные точки
- Intraoperative allogeneic red blood cell transfusion volume [Срок оценки: From the beginning to the end of the surgery]
Вторичные конечные точки (9)
- The rate of perioperative transfusion of allogeneic blood products [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- The blood loss during the perioperative period [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- The volume of fluid administration during the intraoperative period [Срок оценки: From the beginning to the end of the surgery]
- The coagulation function tests during the perioperative period [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- The intraoperative hemodynamic indexes [Срок оценки: From the beginning to the end of the surgery]
- Perioperative embolic events [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Perioperative pulmonary infection [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Perioperative wound infection [Срок оценки: From the start of surgery to discharge or the 7th day following the operation, which comes first]
- Length of stay in hospital [Срок оценки: Through study completion, an average of 1 year]
Критерии участия
Критерии включения
- age 18 to 75 years;
- undergoing elective bone tumor resection surgery;
- preoperative hemoglobin ≥11 g/dL;
Критерии исключения
- using a tourniquet;
- palliative operation or minimally invasive surgery;
- BMI<18.5 or >30Kg/m\^2;
- international normalized ratio (INR) >1.5 or platelet count <100 × 10\^9/L;
- cardiopulmonary insufficiency;
- hepatic and renal dysfunction;
- active infectious disease;
- allergy to succinyl gelatin;
- pregnancy;
- declined participation in the study or declined blood transfusion
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Ханчжоу
Идентификаторы
NCT: NCT06459141 · 2024-0156