Major Bleeding Risk Associated With Antithrombotics

Major Haemorrhage Clinical Trial

— SACHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886533
• Other study ID #: 35RC12_8986_SACHA
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: February 2017
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6484
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Major Haemorrhage

Intervention

Other:
• Antithrombotic
Collection of clinical, biological data

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	Clinique de l'Anjou	Angers
France	CHU de Brest	Brest
France	Hôpital Inter-Armées	Brest
France	Hôpital Privé Sévigné	Cesson Sévigné
France	Clinique des Cèdres	Echirolles
France	CHU de Grenoble	Grenoble
France	Groupe Hospitalier Mutualiste	Grenoble
France	CHU de Nantes	Nantes
France	Nouvelles Cliniques Nantaises	Nantes
France	CHU de Rennes	Rennes
France	Centre Hospitalier Privé	Saint Grégoire

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 months
Secondary	Number of patients receiving treatment for drug-induced haemorrhage		6 months
Secondary	Vital status after major bleeding		1 month
Secondary	Vital status after major bleeding		6 months