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临床试验/NCT07416045
NCT07416045招募中不适用

A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on the Morphology, Mechanical Properties and Functions of Red Blood Cells

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年1月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Red blood cell biochemical indicators

研究概览

简要总结

This study aims to investigate the effects of linear accelerator X-ray irradiation on the structure, mechanics and functional characteristics of red blood cells recovered from patients with malignant tumors during surgery. A red blood cell damage evaluation system based on multiple-dimensional indicators is established. Through atomic force microscopy, microfluidic chips and biochemical detection methods, the changes in red blood cell membrane structure, deformability and oxygen-carrying capacity under different irradiation doses are systematically evaluated. The dose-effect relationship between irradiation dose and red blood cell damage degree is clarified, providing experimental evidence for the safe dose of irradiation processing of autologous blood during surgery.

详细描述

This study aims to address the current lack of systematic evaluation methods for the survival status and damage characteristics of red blood cells after irradiation treatment. It is difficult to accurately assess the long-term functional activity of irradiated red blood cells in the body. By combining techniques such as microtubule suction, microfluidic technology, microscopy, and cross-scale numerical simulation, this study will comprehensively evaluate the dynamic changes in the geometric shape, mechanics, and flow characteristics of red blood cells under X-ray irradiation from a linear accelerator from multiple dimensions. It will also explore the cross-scale mechanical mechanisms of the ultrastructure, deformation, and flow characteristics changes of the red blood cell membrane caused by irradiation, providing further preclinical evidence for the transformation application of linear accelerators in the recovery of autologous blood for tumor surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective surgery for malignant tumors
  • Age: 18 - 65 years old
  • It is estimated that the surgical bleeding will be greater than or equal to 500 milliliters.

排除标准

  • Disorders of red blood cell production (such as aplastic anemia, megaloblastic anemia, iron deficiency anemia, leukemia, myelofibrosis, etc.)
  • Diseases caused by increased destruction of red blood cells (abnormalities in red blood cell membranes such as hereditary spherocytosis and paroxysmal nocturnal hemoglobinuria; abnormalities in hemoglobin such as thalassemia; abnormalities in red blood cell-related enzymes such as glucose-6-phosphate dehydrogenase deficiency, etc.)

结局指标

主要结局

Red blood cell biochemical indicators

时间窗: 1day

The biochemical changes of the treated red blood cells were detected through methods such as blood gas analyzer and related quantitative ELISA kits.

Mechanical characteristics of red blood cells

时间窗: 3 day

The mechanical property changes of red blood cells after treatment were detected by techniques such as microtubule suction and microfluidics

Morphological characteristics of red blood cells

时间窗: 1day

Using scanning electron microscope (SEM) and transmission electron microscope (TEM), observe the changes in the surface structure and ultrastructure of the red blood cell membrane. Also, study the morphological alterations of red blood cells.

次要结局

  • Circulating tumor cell clearance indicator(1 day)

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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