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Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02858518
Acronym
PREDIC-AGE
Enrollment
120
Registered
2016-08-08
Start date
2015-03-31
Completion date
2016-12-31
Last updated
2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Gerontology

Keywords

anticoagulant

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.

Interventions

OTHERquestionnaires

scales : HEMORR2HAGES (hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...), HAS-Bled (arterial hypertension, renal function, liver function, cerebrovascular accident...), ATRIA (anemia, serious kidney diseases, hypertension, antecedent...), Shireman (gender, age, hemorrhage, diabetes, anemia...), Charlson (age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer) and standardised geriatric assessment (comorbidities, cognition, mobility, pain, nutrition, living environment...)

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
80 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
scale : standardised geriatric assessmentat baselinecomorbidities, cognition, mobility, pain, nutrition, living environment...
scale : shiremanat baselinegender, age, hemorrhage, diabetes, anemia...
scale charlsonat baselineage, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer
scale : HEMORR2HAGESat baselinehepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...
scale : HAS-Bledat baselinearterial hypertension, renal function, liver function, cerebrovascular accident...
scale : ATRIAat baselineanemia, serious kidney diseases, hypertension, antecedent...

Secondary

MeasureTime frameDescription
genotypingat baselineCYP2C9
Occurrence of major bleeding event or not majorat baseline and 6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026