Assessment of a Procedure for Managing Oral Anticoagulants (NACO) in the Management of Fractures

NCT ID: NCT06220422

Last Updated: 2024-06-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-26

Study Completion Date

2024-04-10

Brief Summary

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The purpose of this study is to demonstrate that by allowing patients with an anticoagulant level less than 100 ng/ml to have their fracture managed surgically, will reduce the delay in surgery and therefore the complications associated. It will also demonstrate that there are no more complications with this new management than from remaining with a bleeding fracture.

Detailed Description

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Fracture of the upper extremity of the femur are constantly on the increase and represent a public health issue in a population with increasing life expectancy. In the majority of cases, this fracture requires rapid surgical treatment, ideally within 48 hours, before complications, associated with the supine position, appear. A prolonged surgical delay is responsible for multiple complications and increase mortality in a potentially comorbid and fragile population.

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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Femur Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients on NACO undergoing surgery for fracture of the upper end of the femur,
* 18 years and over,
* Informed patients who did not object.

Exclusion Criteria

* Patients under court protection,
* Patients under guardianship/curators .
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital NOVO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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CHRD0123

Identifier Type: -

Identifier Source: org_study_id

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