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

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 ] [ 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.

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 ] [ 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.

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


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	April 26, 2012
Last Updated:	May 29, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:


Irregular antibody screening

ClinicalTrials.gov processed this record on September 26, 2016

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