Irregular Antibody ScreeningNCT01589133
Surgiscreen Registration
An observational study of Irregular Antibody Screening, run by Johnson & Johnson Medical, China at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irregular Antibody Screening
- How many people
- 3,109 participants
- Where
- 4 sitesChina
- Study dates
- May 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who need transfusion therapy in investigator sites.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Cancer Institute & Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Shanghai Blood Center
Shanghai, Shanghai Municipality, 200051
About this study
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
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (1)
The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irregular Antibody ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589133
- Sponsor's protocol ID
- OCD-201108
- Status last verified
- Apr 2012
- First submitted
- 26 Apr 2012
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01589133
- Acronym / sponsor ID
- OCD-201108
- Conditions
- Irregular Antibody Screening
- Keywords
- Irregular antibody screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,109 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who need transfusion therapy in investigator sites.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irregular Antibody Screening, run by Johnson & Johnson Medical, China at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The consistency of the results of irregular antibody screening of investigational reagent and control reagent. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.