Major Bleeding Risk Associated With Antithrombotics (SACHA)

November 15, 2023 updated by: Rennes University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6484

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • CHU d'Angers
      • Angers, France, 49000
        • Clinique de l'Anjou
      • Brest, France, 29 240
        • Hôpital Inter-Armées
      • Brest, France, 29 609
        • CHU de Brest
      • Cesson Sévigné, France, 35576
        • Hôpital privé Sévigné
      • Echirolles, France, 38432
        • Clinique des Cèdres
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Grenoble, France, 38028
        • Groupe Hospitalier Mutualiste
      • Nantes, France, 44093
        • CHU de Nantes
      • Nantes, France, 44277
        • Nouvelles Cliniques Nantaises
      • Rennes, France, 35033
        • CHU de Rennes
      • Saint Grégoire, France, 35768
        • Centre Hospitalier Prive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with major bleeding events associated with antithrombotic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients receiving treatment for drug-induced haemorrhage
Time Frame: 6 months
6 months
Vital status after major bleeding
Time Frame: 1 month
1 month
Vital status after major bleeding
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

December 31, 2015

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (Estimated)

September 1, 2016

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC12_8986_SACHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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