Blood DyscrasiaNCT02586818
Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting
An observational study of Blood Dyscrasia, run by Accriva Diagnostics.
Trial summary
This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Dyscrasia
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population to be studied consists of subjects who require oral anticoagulant therapy with VKA in accordance with the approved label indications for VKA administration. Normal healthy individuals will also be enrolled to collect data to support the low end of the lnRhythm system detection range.
Who may be able to join
- The subjects must be > 18 years of age.
- The subjects must be willing and competent to sign an informed consent.
- The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.
Who cannot join
- The subject is unable to donate fingerstick and venous blood samples.
- The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
- The subject is enrolled in any other study that involves an investigational drug and/or device.
- Additional Inclusion Criteria - Therapeutic Group
- The subject must require oral VKA anticoagulant therapy.
- The patient must have been anticoagulated for at least three months prior to enrollment.
- Additional Exclusion Criteria - Normal Group
- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.
About this study
Official title: Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting
This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.
- Conditions
- Blood Dyscrasia
- Medical subject headings
- Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of INR measurements
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Primary completionJul 2017 (estimated)
Why it stopped: Product was discontinued.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood DyscrasiaStudies 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accriva Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586818
- Sponsor's protocol ID
- INR_CSP_015_0002_RA
- Status last verified
- Aug 2021
- First submitted
- 22 Oct 2015
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting
- ClinicalTrials.gov ID
- NCT02586818
- Acronym / sponsor ID
- INR_CSP_015_0002_RA
- Conditions
- Blood Dyscrasia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Product was discontinued.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Accriva DiagnosticsIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Primary completion
- Jul 2017 (estimated)
- First posted
- 26 Oct 2015 (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.
This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population to be studied consists of subjects who require oral anticoagulant therapy with VKA in accordance with the approved label indications for VKA administration. Normal healthy individuals will also be enrolled to collect data to support the low end of the lnRhythm system detection range.
Key inclusion criteria (3 listed)
- The subjects must be > 18 years of age.
- The subjects must be willing and competent to sign an informed consent.
- The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.
Key exclusion criteria (8 listed)
- The subject is unable to donate fingerstick and venous blood samples.
- The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
- The subject is enrolled in any other study that involves an investigational drug and/or device.
- Additional Inclusion Criteria - Therapeutic Group
- The subject must require oral VKA anticoagulant therapy.
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
Comparison of INR measurements
Time frame: 5 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Dyscrasia, run by Accriva Diagnostics.
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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Comparison of INR measurements (time frame: 5 weeks). 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 Aug 2021.