Surgiscreen Registration

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01589133

First Posted: May 1, 2012

Last Update Posted: May 30, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Johnson & Johnson Medical, China

Purpose

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
Irregular Antibody Screening


Study Type:	Observational
Study Design:	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

Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:

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:

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.


Enrollment:	3109
Study Start Date:	May 2012
Study Completion Date:	October 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
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

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


Responsible Party:	Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:	NCT01589133 History of Changes
Other Study ID Numbers:	OCD-201108
First Submitted:	April 26, 2012
First Posted:	May 1, 2012
Last Update Posted:	May 30, 2013
Last Verified:	April 2012

Keywords provided by Johnson & Johnson Medical, China:


Irregular antibody screening

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