Surgiscreen Registration

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johnson & Johnson Medical, China

ClinicalTrials.gov Identifier:

NCT01589133

First received: April 26, 2012

Last updated: May 29, 2013

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 26, 2012
Last Updated Date	May 29, 2013
Start Date ^ICMJE	May 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 28, 2012)	The consistency of the results of irregular antibody screening of investigational reagent and control reagent. [ Time Frame: baseline ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01589133 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 28, 2012)	The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma). [ Time Frame: baseline ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Surgiscreen Registration
Official Title ^ICMJE	A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA Description: Plasma or Serum left after routine clinical testing.
Sampling Method	Non-Probability Sample
Study Population	Patients who need transfusion therapy in investigator sites.
Condition ^ICMJE	Irregular Antibody Screening
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3109
Completion Date	October 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01589133
Other Study ID Numbers ^ICMJE	OCD-201108
Has Data Monitoring Committee	No
Responsible Party	Johnson & Johnson Medical, China
Study Sponsor ^ICMJE	Johnson & Johnson Medical, China
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Johnson & Johnson Medical, China
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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