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临床试验/NCT07669155
NCT07669155尚未招募不适用

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

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
420
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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;
  • declined participation in the study or declined blood transfusion

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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