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Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04471688
Enrollment
10000
Registered
2020-07-15
Start date
2020-06-01
Completion date
2021-12-31
Last updated
2020-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease Screening

Keywords

nucleic acid, pre-transfusion, pre-operative, pathogen detection

Brief summary

In the past ten years, nucleic acid detection technology has overcome the limitations of serological detection, reduced missed detections due to window period, occult infection, etc., and its application in the field of pathogen detection has developed rapidly. Since 2015, domestic blood collection and supply institutions have fully popularized nucleic acid testing. The safety screening of blood sources mostly adopts the method of combining two times of enzyme-free negative and one time of nucleic acid testing, which excludes the guarantee of blood safety to the greatest extent. At present, the clinical pre-transfusion and pre-operative infectious disease screening in our country is still serological detection. The use of nucleic acid detection for infectious disease screening can better realize the significance of patients' pre-transfusion/pre-operative infectious disease screening. Therefore, this study will analyze the nucleic acid detection technology and clinical serological detection technology in order to solve three problems: * Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening; ② Explore the confirmation process of the gray area results of infectious disease serological testing; ③ Better realize the significance of screening for patients' infectious diseases.

Interventions

DIAGNOSTIC_TESTinfectious disease screening

Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening

Sponsors

SANSURE BIOTECH INC.
CollaboratorUNKNOWN
The Third Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* hosipital patients

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Hepatitis B Infection Analysis result20190601-20201231Nucleic acid examination and serological test
Hepatitis C Infection Analysis result20190601-20201231Nucleic acid examination and serological test
HIV Infection Analysis result20190601-20201231Nucleic acid examination and serological test

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026