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Completed

NCT Number: NCT02858518

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Gerontology Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de FEURS, Feurs, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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...)

Primary outcomes

  1. scale : HEMORR2HAGES

    Time frame: at baseline

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

  2. scale : HAS-Bled

    Time frame: at baseline

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

  3. scale : ATRIA

    Time frame: at baseline

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

  4. scale : shireman

    Time frame: at baseline

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

  5. scale charlson

    Time frame: at baseline

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

  6. scale : standardised geriatric assessment

    Time frame: at baseline

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

Secondary outcomes

  1. Occurrence of major bleeding event or not major

    Time frame: at baseline and 6 months

  2. genotyping

    Time frame: at baseline

    CYP2C9

  3. genotyping

    Time frame: at baseline

    VKCRC1

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: PREDIC-AGE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 8, 2016
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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