Major Haemorrhage
Conditions
Keywords
Major haemorrhage, Oral anticoagulation, Antiplatelet drugs, Gastrointestinal bleeding, Intracranial haemorrhage
Brief summary
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
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.
Interventions
OTHERAntithrombotic
Collection of clinical, biological data
Sponsors
Rennes University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients receiving treatment for drug-induced haemorrhage | 6 months |
| Vital status after major bleeding | 1 month |
Countries
France
Outcome results
None listed