Major Bleeding Risk Associated With Antithrombotics

Completed

• Conditions: Major Haemorrhage

• Registration Number: NCT02886533
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-26
• Study First Posted: 2016-09-01
• Status Verified: 2017-02
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6484

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Vital status after major bleeding	6 months
Number of patients receiving treatment for drug-induced haemorrhage	6 months

Trial Locations

Locations (12)

Clinique de l'Anjou; 🇫🇷 Angers, France

Groupe Hospitalier Mutualiste; 🇫🇷 Grenoble, France

Hôpital Privé Sévigné; 🇫🇷 Cesson Sévigné, France

CHU de Rennes; 🇫🇷 Rennes, France

Clinique des Cèdres; 🇫🇷 Echirolles, France

CHU d'Angers; 🇫🇷 Angers, France

Hôpital Inter-Armées; 🇫🇷 Brest, France

CHU de Brest; 🇫🇷 Brest, France

Centre Hospitalier Privé; 🇫🇷 Saint Grégoire, France

CHU de Grenoble; 🇫🇷 Grenoble, France

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes, France

CHU de Nantes; 🇫🇷 Nantes, France