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

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

Study Overview

• Status: Recruiting
• Conditions: Erythrocyte Destruction

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Fengjiang Zhang; Phone Number: +8613858007629; Email: zrzfj@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • The Second Affiliated Hospital, School of Medicine, Zhejiang University,anesthesiology department,
      • Contact: Fengjiang ZHANG; Phone Number: +8613858007629; Email: zrzfj@zju.eud.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 65 years old who are scheduled to undergo elective surgery for malignant tumors

Description

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.)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red blood cell biochemical indicators	The biochemical changes of the treated red blood cells were detected through methods such as blood gas analyzer and related quantitative ELISA kits.	1day
Mechanical characteristics of red blood cells	The mechanical property changes of red blood cells after treatment were detected by techniques such as microtubule suction and microfluidics	3 day
Morphological characteristics of red blood cells	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.	1day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor cell clearance indicator	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.	1 day

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): January 28, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Red Blood Cell; Oncologic Surgery; linear accelerator; Intraoperative Blood Salvage
• Other Study ID Numbers: 2024-0164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No