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ClinicalTrials.gov Identifier: NCT01589133
Recruitment Status : Completed
First Posted : May 1, 2012
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical, China

Study Description
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Brief Summary:
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.

Condition or disease
Irregular Antibody Screening

Study Design
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Study Type : Observational
Actual Enrollment : 3109 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Plasma or Serum left after routine clinical testing.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who need transfusion therapy in investigator sites.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589133


Locations
China, Beijing
Cancer Institute & Hospital, Chinese Academy of Medical Science
Beijing, Beijing, China, 100021
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Shanghai
Shanghai Changzheng Hospital
Shanghai, Shanghai, China, 200003
Shanghai Blood Center
Shanghai, Shanghai, China, 200051
Sponsors and Collaborators
Johnson & Johnson Medical, China
More Information
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Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT01589133     History of Changes
Other Study ID Numbers: OCD-201108
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: April 2012

Keywords provided by Johnson & Johnson Medical, China:
Irregular antibody screening