This trial has been completed.

Condition major haemorrhage
Treatment antithrombotic
Sponsor Rennes University Hospital
Start date January 2013
End date December 2015
Trial size 6484 participants
Trial identifier NCT02886533, 35RC12_8986_SACHA


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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
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

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Rennes University Hospital.