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

Hôpital NOVO

Status: Completed

Conditions: Femur Fracture

Treatments: Procedure: Standard Department procedure for managing direct-acting oral anticoagulants; Procedure: New Department procedure for managing direct-acting oral anticoagulants

Study type: Observational

Funder types: Other

Identifiers

NCT06220422

CHRD0123

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 .

Trial design

127 participants in 2 patient groups

Standard Department procedure for managing direct-acting oral anticoagulants

Description:

Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021

Treatment:

Procedure: Standard Department procedure for managing direct-acting oral anticoagulants

New Department procedure for managing direct-acting oral anticoagulants

Description:

Intervention Description New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021

Treatment:

Procedure: New Department procedure for managing direct-acting oral anticoagulants