Surgiscreen Registration

May 29, 2013 updated by: Johnson & Johnson Medical, China

A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University first hospital
      • Beijing, Beijing, China, 100021
        • Cancer Institute & Hospital, Chinese Academy of Medical Science
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China, 200051
        • Shanghai Blood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who need transfusion therapy in investigator sites.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
Time Frame: baseline
The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of two reagents.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).
Time Frame: baseline
The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of investigational reagent on serum and plasma from same patient.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Medical, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 28, 2012

First Posted (Estimate)

May 1, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OCD-201108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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