Blood Donation From Warfarin Users for the Development of POC INR Monitor

NCT02355730 | Unknown

• 1 other identifier: RDE03
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to further develop and optimise the design and manufacturing process of a handheld device to monitor and manage Warfarin (blood thinning anticoagulation drug) therapy. The device comprises of a handheld instrument and a disposable test strip and reports how blood coagulation is working in terms of standardised units called International Normalised Ratio (INR). A single drop of fresh whole blood and plasma will be added to the strip and the INR result displayed on the instrument. Blood samples are to be collected from patients attending a hospital based INR clinic who are on Warfarin Therapy. The samples are to be used in a series of experiments in the laboratory to test the Microvisk POC INR Monitors accuracy, precision, stability and robustness.

Conditions

Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors.

  The Primary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the Generation 1 system using the blood samples from the same donors. Those differences will be reported in terms of accuracy, precision and sensitivity to interferents.

  2 years

Secondary Outcomes (1)

• The Secondary Outcome will be measured in terms of differences in International Normalised Ratio when the Generation 2 system is tested against the International Standard Method using the blood samples from the same donors.

  2 years

Study Arms (1)

Warfarin Patients

EXPERIMENTAL

Single Arm - blood collection by venepuncture in patients undergoing Warfarin Therapy

Procedure: Venepuncture

Interventions

Venepuncture PROCEDURE

Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.

Warfarin Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male or female, greater than 18 years of age
• Subject is receiving warfarin (or warfarin-like) therapy as part of their clinical care
• Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent

You may not qualify if:

• Subjects aged \<18 years of age
• Subjects who are unable to give written consent

Sponsors & Collaborators

• Microvisk Technologies Ltd: lead

Study Sites (1)

Royal Liverpool & Broadgreen University Hospital NHS Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Pulmonary Embolism; Venous Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Cheng-Hock Toh, Professor

  Royal Liverpool and Broadgreen University Hospital Trust

  STUDY CHAIR

Central Study Contacts

Joseph Booth

CONTACT

+44 845 956 9900; joebooth@microvisk.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: February 4, 2015
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 4, 2015

Record last verified: 2015-01

Locations

GB (1)