Major Bleeding Risk Associated With Antithrombotics

Study Overview
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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

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.

Official Title
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Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study

Conditions
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Major Haemorrhage

Intervention / Treatment
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* Other: Antithrombotic


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Antithrombotic|Collection of clinical, biological data|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of the risk of major bleeding of all classes of antithrombotic drugs, in particular the risk of major bleeding of anticoagulants, vitamin K antagonist (VKA) and direct oral anticoagulants (DOAC), in real clinical practice | Unstable hemodynamic (systolic arterial pressure < 90 mmHg or mean arterial pressure < 65 mm Hg), hemorrhagic shock, uncontrollable bleeding, need for transfusions, need for haemostatic procedure (embolization, endoscopic procedure, surgery), or a life-threatened location of bleeding such as intracranial, intra-spinal, intraocular, retroperitoneal, pericardial, thoracic, intra-articular, intramuscular hematoma with compartment syndrome, acute gastrointestinal bleeding | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving treatment for drug-induced haemorrhage |  | 6 months | 
| Vital status after major bleeding |  | 1 month | 
| Vital status after major bleeding |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major haemorrhage, Oral anticoagulation, Antiplatelet drugs, Gastrointestinal bleeding, Intracranial haemorrhage