Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00878137
Other study ID # POC Comparison 08-1883
Secondary ID
Status Completed
Phase N/A
First received April 6, 2009
Last updated October 12, 2012
Start date March 2009
Est. completion date May 2009

Study information

Verified date October 2012
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
INR by point-of-care instruments and venopuncture
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.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill International Technidyne Corporation

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT01475149 - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE) N/A
Completed NCT00537290 - A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome Phase 2
Recruiting NCT00616317 - Register for Pediatric Patients With Antiphospholipid Syndrome (APS): European Project Extended Internationally Study
Recruiting NCT00198068 - Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Completed NCT00180817 - Longitudinal Study of the Clinical and Haematological Cause of Women With Antiphospholipid Antibodies.
Completed NCT03682419 - Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL) N/A
Not yet recruiting NCT03303508 - Measurement of Anti-dsDNA by Both CLIFT & ELISA N/A
Recruiting NCT04262492 - International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
Withdrawn NCT00180778 - Steroids and Antiphospholipid Syndrome- Related Pregnancy Loss Phase 1/Phase 2
Enrolling by invitation NCT05583305 - Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome
Recruiting NCT05644210 - Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE
Recruiting NCT02303171 - Use of Warfarin After the First Trimester in Pregnant Women With APS Phase 4
Not yet recruiting NCT06420154 - The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases Early Phase 1
Completed NCT00674297 - Effects of Fluvastatin on Proinflammatory and Prothrombotic Markers in Antiphospholipid Syndrome Patients Phase 2
Recruiting NCT05859997 - Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases N/A
Recruiting NCT06373003 - Negative Antiphospholipid Syndrome: a Multicentric Study
Recruiting NCT06373926 - Evaluation of Cell Membrane Expression of Annexin A2 on Monocytes by Flow Cytometry in Primary Antiphospholipid Syndrome N/A
Recruiting NCT01818505 - The Influence of Antiphospholipid Antibodies on the Relationship Between Hyperurecemia, Gout and Metabolic Syndrome N/A
Completed NCT01104337 - Drug Interaction Between Paracetamol and Warfarin Phase 4
Completed NCT05313048 - Prospective Observational Study to Evaluate a Possible Change in APS Antibody Profiles After COVID-19 Infection or Vaccination