Acute Normovolemic Hemodilution in Bone Cancer Surgery
The Effect of Acute Normovolemic Hemodilution on Requirement of Allogeneic Red Blood Cell in Patients Undergoing Bone Cancer Surgery
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
420
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310000
- The Second Affiliated Hospital of Zhejiang University anesthesiology department
-
首席研究员:
- Min Yan, Doctor
-
接触:
- Min Yan, Doctor
- 电话号码:+86 15888210247
- 邮箱:zryanmin@zju.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- age 18 more than years;
- undergoing elective bone cancer resection surgery;
- preoperative hemoglobin ≥12 g/dL;
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Control group
Except for not undergoing ANH, other care managements are the same as the experimental group
|
|
|
实验性的:ANH group
Patients in the ANH group had whole blood withdrawn after induction of anesthesia.
Meanwhile, patients receive colloid solution according to the volume of blood withdrawn.
|
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perioperative red blood cell transfusion rate
大体时间:hospital discharge, an average of 10 days
|
The number of patients receiving RBCs transfusion from the start of surgery to hospital discharge.
|
hospital discharge, an average of 10 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The rate of perioperative transfusion of allogeneic blood products
大体时间:hospital discharge, an average of 10 days
|
This includes blood products such as plasma and platelets, erythrocytes
|
hospital discharge, an average of 10 days
|
|
Wound drainage volume
大体时间:hospital discharge, an average of 10 days
|
Accumulated amount of wound drainage after surgery
|
hospital discharge, an average of 10 days
|
|
Unplanned re-operation
大体时间:hospital discharge, an average of 10 days
|
Unplanned re-operation due to bleeding, infection or other reasons
|
hospital discharge, an average of 10 days
|
|
Perioperative hemoglobin concentration
大体时间:hospital discharge, an average of 10 days
|
hemoglobin concentration during hospitalization
|
hospital discharge, an average of 10 days
|
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The coagulation function tests during the perioperative period
大体时间:hospital discharge, an average of 10 days
|
This includes thromboelastography result
|
hospital discharge, an average of 10 days
|
|
Complication
大体时间:hospital discharge, an average of 10 days
|
embolic events, pulmonary complications, infection, acute kidney injury, death.
Diagnose according to radiologic examination, sign and symptom
|
hospital discharge, an average of 10 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2026年7月1日
研究完成 (估计的)
2028年5月1日
研究注册日期
首次提交
2026年6月22日
首先提交符合 QC 标准的
2026年6月22日
首次发布 (实际的)
2026年6月25日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月22日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026 0947
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.