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Accuracy of a Portable International Normalized Ratio Monitor in Elderly Patients

NCT01930916 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-04-09

No results posted yet for this study

Summary

Oral anticoagulants vitamin K antagonists (VKA) have been used for many years in the treatment of thromboembolic disorders, which are among the most costly diseases in terms of public health resources. According to the Agence française de sécurité sanitaire des produits de santé (AFSSAPS), it was estimated at about 900,000 the number of patients treated with VKA in 2008 (more than 1% of the French population). VKA are at the origin of many adverse effects, given their narrow therapeutic window. They are the cause of the death of approximately 5000 patients per year. The use of this therapy is a priority axis of reflection for the Haute Autorité de Santé.

The interregion G4 (Nord Pas de Calais, Normandy, Picardy), with more than 9 million people, is particularly affected by this problem.

University hospitals of our interregion, given their very substantial regional referral activity, are actually involved in managing VKA adverse side effects.

Elderly population constitutes the majority of prescriptions. The main objective of this study is to compare INR of people older than 75 years measured by traditional method with those measured by capillary method with INRatio2 supply.

The secondary objective is to show that this measure is not affected by the presence or absence of anti-phospholipid antibodies, probably very prevalent in the elderly, as well as to test the variability of INR measurement between different hospital.

Conditions

  • Blood Coagulation Disorders
  • Blood Coagulation Disorder With Prolonged Bleeding Time
  • Blood Coagulation Disorder With Prolonged Coagulation Time

Interventions

DEVICE

INR capillary measurement with INRatio 2 device

INR capillary measurement with INRatio 2 device

OTHER

antiphospholipid antibodies and lupus anticoagulant

Rate of antiphospholipid antibodies and lupus anticoagulant dosage A 5ml blood sample obtained by veinous punction.

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Principal Investigators

  • Boris Bienvenu, M.D,Ph.D · Centre hospitalier régional universitaire de Caen

  • Jean Jacques Dutheil · Centre hospitalier régional universitaire de Caen

  • Laurent Auboire, M.D · Centre hospitalier régional universitaire de Caen

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-11-30
Completion
2014-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930916 on ClinicalTrials.gov