A Substudy of 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: Bone Tumor, Acute Normovolemic Hemodilution, Goal-Directed Fluid Therapy. 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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Обзор
The prevention of perioperative anemia has the potential to reduce complications, hospital stays, and long-term prognosis in patients undergoing bone tumor surgery. Data from previous studies suggest that the clinical efficacy of acute normovolemic hemodilution (ANH) has always been controversial, and intraoperative fluid administration strategy is an important confounding factor. The HEAL trial will assess whether ANH will improve postoperative hemoglobin levels when applying goal-directed fluid therapy in patients undergoing bone tumor surgery.
Подробное описание
Bone tumor surgery is associated with a significant risk of perioperative blood loss, with blood loss usually in the range of approximately 500-1000 ml. The postoperative anemia caused by blood loss 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, and intraoperative fluid administration strategy is an important confounding factor. As goal-directed fluid therapy (GDFT) is increasingly used in clinical practice, it is of great importance to explore the efficacy of ANH in patients undergoing fluid management using GDFT.
Bone tumor surgery is an ideal setting to evaluate ANH in GDFT, as the procedure is associated with high blood loss and infusion. This trial has been designed as a randomized, controlled trial to determine whether ANH will improve postoperative hemoglobin levels when applying GDFT in patients undergoing bone tumor 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
- Hemoglobin concentration on the first day after surgery [Срок оценки: The first day after surgery]
Вторичные конечные точки (7)
- 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]
- 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]
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: NCT06881498 · 2024 0584