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

Completed

• Conditions: Atrial Fibrillation; Gerontology
• Interventions: Other: questionnaires

• Registration Number: NCT02858518
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Status Verified: 2016-08
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with atrial fibrillation with anticoagulant treatment	questionnaires	-

Primary Outcome Measures

Name	Time	Method
scale : HEMORR2HAGES	at baseline	hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...
scale : ATRIA	at baseline	anemia, serious kidney diseases, hypertension, antecedent...
scale : standardised geriatric assessment	at baseline	comorbidities, cognition, mobility, pain, nutrition, living environment...
scale : HAS-Bled	at baseline	arterial hypertension, renal function, liver function, cerebrovascular accident...
scale : shireman	at baseline	gender, age, hemorrhage, diabetes, anemia...
scale charlson	at baseline	age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer

Secondary Outcome Measures

Name	Time	Method
genotyping	at baseline	VKCRC1
Occurrence of major bleeding event or not major	at baseline and 6 months

Trial Locations

Locations (5)

CH de FIRMINY; 🇫🇷 Firminy, France

CH de ROANNE; 🇫🇷 Roanne, France

CH de FEURS; 🇫🇷 Feurs, France

CH de SAINT-CHAMOND; 🇫🇷 Saint-chamond, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France