跳至主要内容
临床试验/NCT01930916
NCT01930916Unknown不适用

Accuracy of a Portable International Normalized Ratio Monitor in a Population Aged 75 Years Old and Over

University Hospital, Caen8 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
8
主要终点
INR by capillary method and INR by veinous punction

研究概览

简要总结

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.

详细描述

Adverse effects of oral anticoagulants (warfarin, fluindione mainly) are bleeding complications and concern 13% of hospitalizations, approximately 17,000 admissions per year. They constitute 12.3% of iatrogenic adverse effect according to the latest results of the survey conducted by the haute autorité de santé (HAS). A study realized in 2000, with 2976 patients, shows that 28.8% of patients were outside of any therapeutic range (<2 or> 4.5). In 2003, a third of french biologists had no knowledge of the indication of VKA treatment of patients at the INR measurement, and more than fifty percent in 2000. When the therapeutic range was known, the value of the INR remained outside it in 30% of cases. The median time between INR equilibration phase was 5 to 6 days, while the recommended time is 2 to 4 days. A quarter of patients in phase equilibrium treatment did not have a measure of INR at least once a month. Followed over a period of a year, patients spent 40% of the time with a value of INR outside the therapeutic range, high-risk area of recurrent thrombosis or hemorrhage. That is why they require regular monitoring of INR.

Currently, this monitoring is done through a blood sample analyzed by a laboratory according to standard techniques.

The use of the INR measurement by capillary method provides a result in less than 3 minutes. This also allows the development of different monitoring strategies. In the context of a self-monitoring measure, the patient himself performs the test using the device and therapeutic adjustment is made by the health care professional.

Data analysis by HAS showed that the use of a self-measurement device significantly improved the time spent in the therapeutic range, reduced the risk of major bleeding and the accident major thromboembolism.

The pathologies treated by VKA are more common in the elderly. They are also more vulnerable to falls, overdoses of these treatments because their pharmacokinetics is amended by polypharmacy, malnutrition, less protein binding. The relative risk of bleeding is multiplicated by two beyond 70 years. Despite the emergence of new anticoagulants in the prevention of complications of arrhythmia (this disorder affect nearly 10% of the population aged over 80 years), VKA remains prevalent because these new drugs have renal elimination that can not be monitored, and can not be dialysable, have no antidote and represent a daily cost about 30 times the VKA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 75 years
  • Recipient of the social security system
  • Patient receiving anti vitamin K treatment
  • Hospitalized in Internal Medicine, Geriatrics, Vascular Medicine
  • Having signed an informed consent to participate in the study

排除标准

  • Contraindication to a digital sampling.
  • Conditions preventing the realization of INRatio2 ® test : Amputation of the extremities, trophic disorders of the extremities.
  • Concomitant use of heparin.
  • Mental or physical illness which do not permit to consent to participate in the study

结局指标

主要结局

INR by capillary method and INR by veinous punction

时间窗: 24 hours

INR by the classical way (punction) and comparison with a capillary method tested here. INR by capillary method is done immediately after inclusion. INR by veinous punction is done on the 24 hours after the inclusion.

次要结局

  • Difference between International normalized ratio (INR) measured in a veinous blood punction and with a capillary method on the same patient and correlated to the level of phospholipid antibodies and lupus anti coagulant(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验