Major Bleeding Risk Associated With Antithrombotics

Rennes University Hospital6,484 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

6,484

Conditions

Major Haemorrhage

Interventions

AntithromboticOTHER

Collection of clinical, biological data

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (12)

Clinique de l'Anjou

Angers, France

CHU d'Angers

Angers, France

Hôpital Inter-Armées

Brest, France

CHU de Brest

Brest, France

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Number of patients receiving treatment for drug-induced haemorrhage

Time frame: 6 months

Vital status after major bleeding

Time frame: 1 month

Vital status after major bleeding

Time frame: 6 months

Data from ClinicalTrials.gov

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