CoaguChek XS in Antiphospholipid Antibody Syndrome (APL) Patients

Antiphospholipid Antibody Syndrome Clinical Trial

Official title:

Accuracy of CoaguChek XS in Patients With Antiphospholipid Antibody Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139072
• Other study ID #: IRB201400096
• Status: Completed
• Phase: N/A
• First received: May 13, 2014
• Last updated: October 3, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see if the CoaguChek XS is accurate in measuring International Normalized Ratio (INR) in patients with Antiphospholipid Antibody Syndrome (APL) receiving warfarin therapy.

Description:

Antiphospholipid Antibody Syndrome (APL) is an autoimmune disease that increases ones risk for blood clots. Therefore, these patients receive anticoagulation therapy with warfarin. Point of care devices such as the CoaguChek XS are often used to monitor International Normalized Ratio (INR) in patients on warfarin. However, the antibodies present in patients with APL may lead to false INR results when using the CoaguChek XS. This study will compare the accuracy of the CoaguChek XS in measuring INR in patients with APL by measuring INR by the CoaguChek XS and a standard lab as a reference point. Patients on warfarin for indications other than APL will be measured by both methods as well to serve as a control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18-65 years of age

• anticoagulated with warfarin for at least 1 month

• Diagnosis of antiphospholipid antibody syndrome for intervention arm

Exclusion Criteria:

• any type of mental disability that would hinder their ability to give informed consent

• any terminal illness or any other condition that could interfere with study completion, that person will be excluded.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antiphospholipid Antibody Syndrome
• Antiphospholipid Syndrome
• Syndrome

Intervention

Device:
• CoaguChek XS
CoaguChek XS will be used to measure INR in patients with APL

Procedure:
• Standard Lab Draw
Patients on warfarin for any indication other than APL will measure INR by venous lab draw

Locations

Country	Name	City	State
United States	UF and Shands Health	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Normalized Ratio (INR)	Compare INR obtained by CoaguChek XS to INR obtained from venous lab draw. Difference of +/- 0.5 considered significant	Day 1 and Day 60	No