A Multi-dimensional Evaluation of the Effects of Linear Accelerator X-ray Irradiation on Red Blood Cells
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In plain language
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- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Erythrocyte Destruction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
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.
Primary outcome measures
- Red blood cell biochemical indicators [Time frame: 1day]
- Mechanical characteristics of red blood cells [Time frame: 3 day]
- Morphological characteristics of red blood cells [Time frame: 1day]
Secondary outcome measures (1)
- Circulating tumor cell clearance indicator [Time frame: 1 day]
Eligibility criteria
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital, School of Medicine, Zhejiang University,anesthesiology dep — Hangzhou
Identifiers
NCT: NCT07416045 · 2024-0164