Surgiscreen Registration

NCT ID: NCT01589133

Last Updated: 2013-05-30

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

COMPLETED

Total Enrollment

3109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen (investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.

Detailed Description

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Conditions

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Irregular Antibody Screening

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Serum or plasma samples left after routine clinical testing;
* Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after collection, or serum or plasma samples stored at -20°C for those separated 3 days after collection.

Exclusion Criteria

* Samples with severe hemolysis, jaundice or chyle-like samples;
* Small sample size insufficient for completing the testing;
* Samples not collected and processed upon the requirements of the instructions.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Medical, China

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cancer Institute & Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Blood Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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OCD-201108

Identifier Type: -

Identifier Source: org_study_id

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