Clinical trial NCT02858518: Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
Official title: Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Gerontology
Keywords: anticoagulant
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients seniors with atrial fibrillation with anticoagulant treatment

Brief summary: Atrial fibrillation (AF) is a rhythmic cardiac activity disorder disturbing hemodynamic blood flow. It is a public health problem with 600,000 to 1 million people involved in France which 2/3 are aged over 75 years. a FA untreated exposes the patient to a significant risk of embolism responsible for a rate stroke (stroke) ischemic estimated at 85%. The anticoagulant standard treatment helps prevent the occurrence of this complication.

However, oral anticoagulation also exposes patients to an increased risk of bleeding. The bleeding risk can be assessed using scales: several being proposed (HEMORR2HAGES, HAS-BLED, ATRIA and scores Shireman and Charlson ...).

moreover, in geriatric hospital care, every patient has a "standardized geriatric assessment" to assess and quantify functional capacity, autonomy, cognitive abilities, nutritional status, psychological state and its environment social.

Thus, the objective of the investigators study was to determine the frequency of each item of each bleeding risk assessment score and geriatric assessment in patients 80 and older hospitalized geriatric ward in the department and with anticoagulant.


Eligibility criteria: Inclusion Criteria:

* hospitalisation in geriatric unit
* Atrial fibrillation treated by anticoagulant treatment (AVK or oral anticoagulation)
* signed inform consent

Exclusion Criteria:

* estimated lifetime less than 6 months
* under guardianship or curatorship
* without support person

Primary outcomes:
measure: scale : HEMORR2HAGES
timeFrame: at baseline
measure: scale : HAS-Bled
timeFrame: at baseline
measure: scale : ATRIA
timeFrame: at baseline
measure: scale : shireman
timeFrame: at baseline
measure: scale charlson
timeFrame: at baseline
measure: scale : standardised geriatric assessment
timeFrame: at baseline
Secondary outcomes:
measure: Occurrence of major bleeding event or not major
timeFrame: at baseline and 6 months
measure: genotyping
timeFrame: at baseline
measure: genotyping
timeFrame: at baseline
Other outcomes:
Locations:
city: Feurs
country: France
facility: CH de FEURS
city: Firminy
country: France
facility: CH de FIRMINY
city: Roanne
country: France
facility: CH de ROANNE
city: Saint-chamond
country: France
facility: CH de SAINT-CHAMOND
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Emilie CRAWFORD-ACHOUR, MD
role: PRINCIPAL_INVESTIGATOR
References: