NCT07416045

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
10mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Jan 2026Feb 2027

Study Start

First participant enrolled

January 28, 2026

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2027

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

February 10, 2026

Last Update Submit

February 10, 2026

Conditions

Keywords

Red Blood Celllinear acceleratorIntraoperative Blood SalvageOncologic Surgery

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Circulating tumor cell clearance indicator

    1 day

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

Central Study Contacts

Fengjiang Zhang

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 17, 2026

Study Start

January 28, 2026

Primary Completion (Estimated)

February 26, 2027

Study Completion (Estimated)

February 26, 2027

Last Updated

February 17, 2026

Record last verified: 2026-01

Locations