Antiphospholipid SyndromeNCT00878137
Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
An observational study of Antiphospholipid Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- INR by point-of-care instruments and venopuncture
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: APLA patients will be identified through the UNC Thrombophilia Program database. Control patients will be recruited at UNC Anticoagulation Clinic visits.
APLA Inclusion Criteria:
- Prolongation of a phospholipid-dependent screening assay, 2) lack of correction of a prolonged screening assay after a 1:1 mix with pooled normal plasma, and 3) correction of a prolonged screening assay by the addition of excess phospholipid. Two positive lupus anticoagulant confirmations at least 3 months apart will be required.
- Diagnosis of anticardiolipin antibodies defined as elevated levels of ACA-IgG (>30) and/or ACA-IgM (>15) on two separate occasions at least 3 months apart.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
APLA Exclusion Criteria:
- Patients whose warfarin dose has changed within the past 2 weeks.
Control Inclusion Criteria:
- No evidence of either a positive LA or ACA diagnosis by confirmation of negative laboratory values and/or documentation of no clinical signs and symptoms concurrent with these conditions.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
Control Exclusion Criteria:
- Patients whose warfarin dose has changed within the past 2 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants
The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA have a higher risk of recurrent thrombosis than do patients without known antibodies. Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for APLA patients after their first episode of thrombosis. In some patients with APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to an influence of the APLA on the INR. In these individuals, alternative monitoring methods, such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. These tests are expensive and not widely available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily accessible to clinicians. Previous research has shown that INR values from 3 older point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM, ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device) and it is unknown if these newer POC instruments are reliable in patients with APLA. The purpose of this study is to determine whether newer POC instruments are reliable in patients with APLA.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- INR by point-of-care instruments and venopuncture
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INR by point-of-care instruments and venopunctureDevice
Three fingersticks will be performed and from each one drop of capillary or venous whole blood collected from a fingerstick performed by the primary investigator to measure PT/INR using the CoaguChekXSTM (10 microliters), ProTimeTM (27 microliters), the investigational ProTime, and INRatioTM 15 microliters) point-of-care instruments and one i.v. blood draw (20 mL of blood) will be performed by a phlebotomist.
| Study group | Role | What they receive |
|---|---|---|
| APLA | Patients with antiphospholipid antibody syndrome. Receives: Device: INR by point-of-care instruments and venopuncture | |
| Control | Patients on warfarin therapy but without antiphosphilipid antibody syndrome. Receives: Device: INR by point-of-care instruments and venopuncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- International Technidyne Corporation
- Responsible party
- Principal investigator, Lauren McKnight, PharmD, CPP, University of North Carolina, Chapel Hill
- Investigators
- Lauren B McKnight, PharmD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878137
- Sponsor's protocol ID
- POC Comparison 08-1883
- Status last verified
- Oct 2012
- First submitted
- 6 Apr 2009
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants
- ClinicalTrials.gov ID
- NCT00878137
- Acronym / sponsor ID
- POC Comparison 08-1883
- Conditions
- Antiphospholipid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- International Technidyne Corporation
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 8 Apr 2009 (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 antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA have a higher risk of recurrent thrombosis than do patients without known antibodies. Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for APLA patients after their first episode of thrombosis. In some patients with APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to an influence of the APLA on the INR. In these individuals, alternative monitoring methods, such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. These tests are expensive and not widely available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily accessible to clinicians. Previous research has shown that INR values from 3 older point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM, ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device) and it is unknown if these newer POC instruments are reliable in patients with APLA. The purpose of this study is to determine whether newer POC instruments are reliable in patients with APLA.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APLA | – | Device: INR by point-of-care instruments and venopuncturePatients with antiphospholipid antibody syndrome. |
| Control | – | Device: INR by point-of-care instruments and venopuncturePatients on warfarin therapy but without antiphosphilipid antibody syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- APLA patients will be identified through the UNC Thrombophilia Program database. Control patients will be recruited at UNC Anticoagulation Clinic visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INR by point-of-care instruments and venopunctureThree fingersticks will be performed and from each one drop of capillary or venous whole blood collected from a fingerstick performed by the primary investigator to measure PT/INR using the CoaguChekXSTM (10 microliters), ProTimeTM (27 microliters), the investigational ProTime, and INRatioTM 15 microliters) point-of-care instruments and one i.v. blood draw (20 mL of blood) will be performed by a phlebotomist. | Device | APLA, Control |
Primary outcome
Not reported in the source record.
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 15 Oct 2012.
Related trials for Antiphospholipid Syndrome
Recruiting
Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study
Antiphospholipid Syndrome
RecruitingObservational study
Follow-up Cohort of Patients With Antiphospholipid Syndrome
Antiphospholipid Syndrome (APS)
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Recruiting
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
Systemic Lupus Erythematosus, Systemic Sclerosis
RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
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.
Lauren B McKnight, PharmD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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 15 Oct 2012.