A Single-center, Prospective, Randomized Controlled Study of the Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Intraoperative and postoperative allogeneic blood transfusion rate
研究概览
简要总结
The goal of this single-center prospective randomized controlled trial is to test and compare the safety and effectiveness of autologous blood transfusion in spinal surgery for lung cancer spinal metastases. The main questions it aims to answer are:
- Does autologous blood transfusion increase the incidence of new metastases?
- Does autologous blood transfusion affect postoperative hemoglobin levels and the number of circulating tumor cells in the blood?
- Can autologous blood transfusion reduce the rate of allogeneic transfusion during and after surgery for spinal metastases?
详细描述
In this study, participants underwent standard open spinal decompression surgery, and when blood transfusion was needed, autologous blood transfusion or allogeneic blood transfusion was used. Participants will be patients with lung cancer spinal metastases. Investigators will use flow cytometry, immunohistochemistry, and tumor cell culture methods to measure the number of circulating tumor cells in the blood before and after autologous blood transfusion.
Investigators will compare participants who receive autologous blood transfusion with those who do not to observe if there are differences in:
- The incidence of new metastases
- The rate of allogeneic transfusion during and after surgery
- Postoperative hemoglobin levels
- The number of circulating tumor cells in the blood
- The cost associated with transfusion
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age range is 18-75 years old;
- •The pathological diagnosis was lung cancer and spinal metastatic tumor;
- •Expected survival > 3 months, can tolerate surgery;
- •Unstable spine; And/or spinal cord nerve compression, nerve function; Progressive decline, palliative spinal open decompression surgery
- •Patients with intraoperative/postoperative Hb<90 g/L or other conditions requiring blood transfusion
排除标准
- •Serious heart dysfunction or heart failure, diagnosed blood system diseases, coagulation disorders;
- •Severe renal insufficiency or need hemodialysis treatment;
- •Sepsis or septicemia;
- •Unable to obtain consent from the patient or family.
结局指标
主要结局
Intraoperative and postoperative allogeneic blood transfusion rate
时间窗: Through study completion, an average of 1 year
The number of allogeneic blood transfusion patients (Intraoperative or postoperative )/ the total number of patients
次要结局
- Incidence of transfusion related adverse reactions(within 14 days post-surgery)
- occurence of new lesions(through study completion, an average of 1 year)
- Number of circulating tumor cells in the blood(within 30 days post-surgery)
研究者
Yu Zhang, PhD
Chief of Orthopedic Oncology
Guangdong Provincial People's Hospital