Risk of Bleeding and Anticoagulation in Atrial Fibrillation: What Predictive Criterion Used? (PREDIC-AGE)

January 20, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Feurs, France, 42110
        • CH de Feurs
      • Firminy, France, 42700
        • CH de Firminy
      • Roanne, France, 42300
        • CH de Roanne
      • Saint-chamond, France, 42400
        • CH de SAINT-CHAMOND
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients seniors with atrial fibrillation with anticoagulant treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with atrial fibrillation with anticoagulant treatment
Other: questionnaires
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...)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of major bleeding event or not major
Time Frame: at baseline and 6 months
at baseline and 6 months
genotyping
Time Frame: at baseline
CYP2C9
at baseline
genotyping
Time Frame: at baseline
VKCRC1
at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Emilie CRAWFORD-ACHOUR, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408020
  • 2014-A01664-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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