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NCT Number: NCT07416045

A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on Red Blood Cells

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital, School of Medicine, Zhejiang University,anesthesiology department,

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Fengjiang ZHANG

CONTACT

[email protected]

+8613858007629

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.)

Treatment and study plan

Primary outcomes

  1. Red blood cell biochemical indicators

    Time frame: 1day

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

  2. Mechanical characteristics of red blood cells

    Time frame: 3 day

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

  3. Morphological characteristics of red blood cells

    Time frame: 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.

Secondary outcomes

  1. Circulating tumor cell clearance indicator

    Time frame: 1 day

    Adopt the method of immunofluorescence staining for testing, qualitative or half quantitative analysis by fluorescence microscope, in the evaluation of circulating tumor cells in the blood after processing residues.

Study contacts

Contact information is provided by the study sponsor or research team.

Fengjiang Zhang

CONTACT

[email protected]

+8613858007629

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.