NCT02886533

Major Bleeding Risk Associated With Antithrombotics

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 6,484 (actual)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Haemorrhage

Interventions

Type	Name	Description
OTHER	Antithrombotic	Collection of clinical, biological data

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-12-31
• Completion: 2015-12-31
• First posted: 2016-09-01
• Last updated: 2023-11-18

Locations

12 sites across 1 country: France