Multicenter Study on Detection Strategy of Infectious Diseases in Blood Transfusion

NCT ID: NCT04471688

Last Updated: 2020-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infectious Disease Screening

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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patients

Preoperative patients needing transfusions

infectious disease screening

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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infectious disease screening

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* hosipital patients

Exclusion Criteria

* No
Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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SANSURE BIOTECH INC.

UNKNOWN

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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the Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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ThirdXiangyaMSID

Identifier Type: -

Identifier Source: org_study_id

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