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

NCT02858518 | Completed

• 2 other identifiers: 14080202014-A01664-43
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Atrial Fibrillation; Gerontology

Keywords

anticoagulant

Outcome Measures

Primary Outcomes (6)

• scale : HEMORR2HAGES

  hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...

  at baseline

• scale : HAS-Bled

  arterial hypertension, renal function, liver function, cerebrovascular accident...

  at baseline

• scale : ATRIA

  anemia, serious kidney diseases, hypertension, antecedent...

  at baseline

• scale : shireman

  gender, age, hemorrhage, diabetes, anemia...

  at baseline

• scale charlson

  age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer

  at baseline

• scale : standardised geriatric assessment

  comorbidities, cognition, mobility, pain, nutrition, living environment...

  at baseline

Secondary Outcomes (3)

• Occurrence of major bleeding event or not major

  at baseline and 6 months

• genotyping

  at baseline

• genotyping

  at baseline

Study Arms (1)

patients with atrial fibrillation with anticoagulant treatment

Other: questionnaires

Interventions

questionnaires OTHER

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...)

patients with atrial fibrillation with anticoagulant treatment

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients seniors with atrial fibrillation with anticoagulant treatment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (5)

CH de FEURS

Feurs, 42110, France

Location

CH de FIRMINY

Firminy, 42700, France

Location

CH de ROANNE

Roanne, 42300, France

Location

CH de SAINT-CHAMOND

Saint-Chamond, 42400, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

classical blood sample : NFS, ionograms, CRP, TSH, albumin, vitamin D, Calcium and coagulation factors + tube for genetic study

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Emilie CRAWFORD-ACHOUR, MD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 8, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 23, 2017

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)