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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

April 26, 2012
May 29, 2013
May 2012
October 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01589133 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Surgiscreen Registration
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma or Serum left after routine clinical testing.

Non-Probability Sample

Patients who need transfusion therapy in investigator sites.

Irregular Antibody Screening
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3109
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01589133
OCD-201108
No
Johnson & Johnson Medical, China
Johnson & Johnson Medical, China
Not Provided
Not Provided
Johnson & Johnson Medical, China
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP