Major HaemorrhageSACHANCT02886533
Major Bleeding Risk Associated With Antithrombotics
An observational study of Major Haemorrhage, run by Rennes University Hospital at 12 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Haemorrhage
- What is being tested?
- Antithrombotic
- How many people
- 6,484 participants
- Where
- 12 sitesFrance
- Study dates
- 1 Jan 2013to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with major bleeding events associated with antithrombotic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Clinique de l'Anjou
Angers, 49000
CHU d'Angers
Angers, 49033
Hôpital Inter-Armées
Brest, 29 240
CHU de Brest
Brest, 29 609
Hôpital Privé Sévigné
Cesson-Sévigné, 35576
Clinique des Cèdres
Échirolles, 38432
Groupe Hospitalier Mutualiste
Grenoble, 38028
CHU de Grenoble
Grenoble, 38043
CHU de Nantes
Nantes, 44093
Nouvelles Cliniques Nantaises
Nantes, 44277
CHU de Rennes
Rennes, 35033
Centre Hospitalier Privé
Saint-Grégoire, 35768
About this study
Official title: 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
Read the 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.
- Conditions
- Major Haemorrhage
- Being tested
- Antithrombotic
- Keywords
- Major haemorrhage, Oral anticoagulation, Antiplatelet drugs, Gastrointestinal bleeding, Intracranial haemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntithromboticOther
Collection of clinical, biological data
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Number of patients receiving treatment for drug-induced haemorrhage
Measured: 6 months
Vital status after major bleeding
Measured: 1 month
Vital status after major bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Major HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886533
- Sponsor's protocol ID
- 35RC12_8986_SACHA
- Acronym
- SACHA
- Status last verified
- Feb 2017
- First submitted
- 18 Aug 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bouget J, Balusson F, Roy PM, Viglino D, Pavageau L, Lacut K, Oger E. Management of epistaxis associated with oral antithrombotic drugs in emergency department and impact on prescription thereafter. Clin Otolaryngol. 2023 May;48(3):457-464. doi: 10.1111/coa.14040. Epub 2023 Feb 28.
PubMed 36789614Bouget 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.
PubMed 35385975Bouget 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.
PubMed 32764775Bouget 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.
PubMed 32415705
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Major Bleeding Risk Associated With Antithrombotics : The SACHA (Surveillance Des Accidents Hémorragiques Graves Sous Antithrombotiques) Study
- ClinicalTrials.gov ID
- NCT02886533
- Acronym / sponsor ID
- SACHA / 35RC12_8986_SACHA
- Conditions
- Major Haemorrhage
- Keywords
- Major haemorrhage, Oral anticoagulation, Antiplatelet drugs, Gastrointestinal bleeding, Intracranial haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,484 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with major bleeding events associated with antithrombotic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntithromboticCollection of clinical, biological data | Other | – |
Primary outcome
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
3 secondary outcomes
Number of patients receiving treatment for drug-induced haemorrhage
Time frame: 6 months
Vital status after major bleeding
Time frame: 1 month
Vital status after major bleeding
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 36789614Bouget J, Balusson F, Roy PM, Viglino D, Pavageau L, Lacut K, Oger E. Management of epistaxis associated with oral antithrombotic drugs in emergency department and impact on prescription thereafter. Clin Otolaryngol. 2023 May;48(3):457-464. doi: 10.1111/coa.14040. Epub 2023 Feb 28.
- Derived from this study: PubMed 35385975Bouget 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.
- Derived from this study: PubMed 32764775Bouget 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.
- Derived from this study: PubMed 32415705Bouget 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Haemorrhage, run by Rennes University Hospital at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02886533, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.