Major Bleeding Risk Associated With Antithrombotics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6484 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2015-12-31

Brief Summary

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Prospective, multicenter, observational study with a three-year inclusion period (from January 1, 2012 to December 31, 2015) and a 6-month follow-up

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Detailed Description

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All adults subjects living in the five well-defined areas affiliated to the French National Health Insurance System and having had at least one reimbursement of any antithrombotic in the 3-year study period are identified by using data from the National Health reimbursement database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIR-AM). SNIIR-AM contains individualized, anonymous and comprehensive data for all health spending reimbursements of affiliated subjects, including basic patient demographic data, medical drugs as well as outpatient medical care, prescribed or performed by health-care professionals from both public and private practices. This allows to calculate a denominator (number of person-years of anti-thrombotic drug exposure).

Crude incidence rates of major bleeding per 100 person-months are calculated in antithrombotic users, anticoagulants and others; stratification on a modified HAS-BLED score allows fair comparison between anti-thrombotic drug classes.

Conditions

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Major Haemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Antithrombotic

Collection of clinical, biological data

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient with major bleeding event associated with antithrombotic drug
* Patient older than 18 years old
* Information on 1 and 6-month follow-up is given pending non-opposition letter

Exclusion Criteria

* Patients with major bleeding events associated with antithrombotic during hospitalization
* Patients with intentional overdose with antithrombotic drugs
* Patients with multi-trauma
* Patients living outside the defined influence areas of the five participating cities

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No