Clinical trial NCT02886533: Major Bleeding Risk Associated With Antithrombotics
Official title: Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Haemorrhage
Keywords: Major haemorrhage
Oral anticoagulation
Antiplatelet drugs
Gastrointestinal bleeding
Intracranial haemorrhage
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 6484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with major bleeding events associated with antithrombotic

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients receiving treatment for drug-induced haemorrhage
timeFrame: 6 months
measure: Vital status after major bleeding
timeFrame: 1 month
measure: Vital status after major bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Clinique de l'Anjou
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: Hôpital Inter-Armées
city: Brest
country: France
facility: CHU de Brest
city: Cesson Sévigné
country: France
facility: Hôpital Privé Sévigné
city: Echirolles
country: France
facility: Clinique des Cèdres
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste
city: Grenoble
country: France
facility: CHU de Grenoble
city: Nantes
country: France
facility: CHU de Nantes
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Rennes
country: France
facility: CHU de Rennes
city: Saint Grégoire
country: France
facility: Centre Hospitalier Privé
Study officials:
References:
citation: Bouget J, Balusson F, Kerbrat S, Roy PM, Viglino D, Lacut K, Pavageau L, Oger E. Clinical use of low-dose parenteral anticoagulation, incidence of major bleeding and mortality: a multi-centre cohort study using the French national health data system. Eur J Clin Pharmacol. 2022 Jul;78(7):1137-1144. doi: 10.1007/s00228-022-03318-x. Epub 2022 Apr 6.
citation: Bouget J, Balusson F, Viglino D, Roy PM, Lacut K, Pavageau L, Oger E. Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study. PLoS One. 2020 Aug 7;15(8):e0237022. doi: 10.1371/journal.pone.0237022. eCollection 2020.
citation: Bouget J, Balusson F, Maignan M, Pavageau L, Roy PM, Lacut K, Scailteux LM, Nowak E, Oger E. Major bleeding risk associated with oral anticoagulant in real clinical practice. A multicentre 3-year period population-based prospective cohort study. Br J Clin Pharmacol. 2020 Dec;86(12):2519-2529. doi: 10.1111/bcp.14362. Epub 2020 Jun 1.