Clinical trial NCT06220422: Assessment of a Procedure for Managing Oral Anticoagulants (NACO) in the Management of Fractures
Official title: Assessment the Benefit of a Service Procedure Management of NACO in the Treatment of Fractures of the Upper Extremity of the Femur
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femur Fracture
Keywords: NACO
Fracture
Upper end of the femur
Department new procedure
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on new anticoagulants undergoing surgery for fracture of the upper end of the femur between 2018 and 2023

Brief summary: 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: 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.

Eligibility 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 .

Primary outcomes:
measure: Highlighting of a reduction in the time to surgical management of fracture of the upper end of the femur by adjusting the preoperative threshold for the dosage of of direct-acting oral anticoagulants
timeFrame: At the end of the study, an average of 1 month
Secondary outcomes:
measure: Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss
timeFrame: At the end of the study, an average of 1 month
measure: Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement
timeFrame: At the end of the study, an average of 1 month
measure: Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity
timeFrame: At the end of the study, an average of 1 month
measure: Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality
timeFrame: At the end of the study, an average of 1 month
measure: Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management
timeFrame: At the end of the study, an average of 1 month
measure: Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management
timeFrame: At the end of the study, an average of 1 month
measure: Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the factors affecting surgical management
timeFrame: At the end of the study, an average of 1 month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Anaesthetics department - Hôpital NOVO - Pontoise Site
Study officials:
affiliation: Hôpital NOVO
name: Dr Amélie TOUSSAINT
role: PRINCIPAL_INVESTIGATOR
References: