Acute Normovolemic Hemodilution in Bone Cancer Surgery

Официальное название

The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery

Обзор

Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for malignant bone tumors often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.

Подробное описание

Malignant bone tumors often lead to skeletal complications, known as skeletal related events (SRE). These complications mainly include pathological fractures, severe pain, and spinal cord compression. Typically, SRE reduces overall survival rates and is associated with loss of mobility and social functioning, decreased quality of life, and significantly increased healthcare costs. Surgical resection is an important means of treating malignant bone tumors. The main goal of surgical treatment is to maintain the patient's function and mobility by relieving pain, preventing impending fractures and/or nerve compression, or stabilizing pathological fractures. Surgery for bone cancer often requires extensive exploration, osteotomy, and prosthetic reconstruction. The surgery involves significant trauma and excessive bleeding from the wound. Therefore, there is a significant risk of perioperative blood loss and transfusion during surgery for malignant bone tumors. However, blood transfusion also brings transfusion related risks to patients, increases the incidence of postoperative complications, and increases the healthcare burden on patients and society. Therefore, it is particularly important to develop a perioperative blood management (PBM) plan for these patients. Acute normovolemic hemodilution (ANH) may help reduce allogeneic red blood cell transfusion. However, There is a lack of high-quality evidence to support the use of ANH in bone cancer surgery.

Вмешательства

• Процедура Acute Normovolemic Hemodilution
  The whole blood is withdrawn after induction of anesthesia. Blood is withdrawn from a large-bore catheter and stored in blood bags. Meanwhile, patients receive colloid solution according to the volume of blood withdrawn.

Первичные конечные точки

• Perioperative red blood cell transfusion rate [Срок оценки: hospital discharge, an average of 10 days]

Вторичные конечные точки (6)

• The rate of perioperative transfusion of allogeneic blood products [Срок оценки: hospital discharge, an average of 10 days]
• Wound drainage volume [Срок оценки: hospital discharge, an average of 10 days]
• Unplanned re-operation [Срок оценки: hospital discharge, an average of 10 days]
• Perioperative hemoglobin concentration [Срок оценки: hospital discharge, an average of 10 days]
• The coagulation function tests during the perioperative period [Срок оценки: hospital discharge, an average of 10 days]
• Complication [Срок оценки: hospital discharge, an average of 10 days]

Критерии участия

Критерии включения

• age 18 more than years;
• undergoing elective bone cancer resection surgery;
• preoperative hemoglobin ≥12 g/dL;

Критерии исключения

• using a tourniquet;
• BMI<18.5 Kg/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 colloid solution;
• 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: NCT07669155 · 2026 0947

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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