Surgiscreen Registration

NCT01589133 | Completed

• 1 other identifier: OCD-201108
• Study Type: observational
• Target: 3,109
• Locations: 1 country
• Sites: 4

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.

Conditions

Irregular Antibody Screening

Keywords

Irregular antibody screening

Outcome Measures

Primary Outcomes (1)

• The consistency of the results of irregular antibody screening of investigational reagent and control reagent.

  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 Outcomes (1)

• The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).

  baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who need transfusion therapy in investigator sites.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Medical, China: lead

Study Sites (4)

Cancer Institute & Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

Shanghai Blood Center

Shanghai, Shanghai Municipality, 200051, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma or Serum left after routine clinical testing.

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2012-04

Locations

CN (4)