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Completed

NCT Number: NCT02886533

Major Bleeding Risk Associated With Antithrombotics

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antithrombotic

Other

Collection of clinical, biological data

Primary outcomes

  1. 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

    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 outcomes

  1. Number of patients receiving treatment for drug-induced haemorrhage

    Time frame: 6 months

  2. Vital status after major bleeding

    Time frame: 1 month

  3. Vital status after major bleeding

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: SACHA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 1, 2016
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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