Assessment of a Procedure for Managing Oral Anticoagulants (NACO) in the Management of Fractures
NCT ID: NCT06220422
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2024-02-26
2024-04-10
Brief Summary
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Detailed Description
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Oral anticoagulants (NACOs) are now widely used in general population for cardiovascular diseases, such as non-valvular atrial fibrillation or thrombo-embolic events. Their activity and circulation rate are assessed by an Anti-Xa assay. The current recommendation for scheduled surgery is an assay with an anti-Xa activity of less than 50 ng/mL.
The acquisition of this assay and the wait for a decrease in anti-Xa activity are currently a factor of lengthening the surgical delay leading to proposal a new dosage. By offering the possibility of surgical management with an anti-Xa activity of less than 100 ng/ml, the purpose is to demonstrate a reduction in surgical delay (less than 48 hours) and associated complications. One of the secondary purposes is also to demonstrate that there are no more intra and post-operative complications with this new protocol.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Standard Department procedure for managing direct-acting oral anticoagulants
Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021
Standard Department procedure for managing direct-acting oral anticoagulants
Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021
New Department procedure for managing direct-acting oral anticoagulants
Intervention Description New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021
New Department procedure for managing direct-acting oral anticoagulants
New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021
Interventions
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Standard Department procedure for managing direct-acting oral anticoagulants
Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021
New Department procedure for managing direct-acting oral anticoagulants
New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021
Eligibility Criteria
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Inclusion Criteria
* 18 years and over,
* Informed patients who did not object.
Exclusion Criteria
* Patients under guardianship/curators .
18 Years
ALL
No
Sponsors
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Hôpital NOVO
OTHER
Responsible Party
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Principal Investigators
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Dr Amélie TOUSSAINT
Role: PRINCIPAL_INVESTIGATOR
Hôpital NOVO
Locations
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Anaesthetics department - Hôpital NOVO - Pontoise Site
Pontoise, , France
Countries
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Other Identifiers
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CHRD0123
Identifier Type: -
Identifier Source: org_study_id
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