Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Department procedure for managing direct-acting oral anticoagulants | Procedure | Standard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Comparison of time from hospital admission to surgery (in hours) between both groups | At the end of the study, an average of 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss | Comparison on the amount of blood lost (mL) between both groups | At the end of the study, an average of 1 month |
| Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement |
Not provided
Inclusion Criteria :
Exclusion Criteria :
Not provided
Not provided
Not provided
Patients on new anticoagulants undergoing surgery for fracture of the upper end of the femur between 2018 and 2023
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Amélie TOUSSAINT | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaesthetics department - Hôpital NOVO - Pontoise Site | Pontoise | 95300 | France |
Not provided
Not provided
Not provided
Not provided
| New Department procedure for managing direct-acting oral anticoagulants | Procedure | New Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021 |
|
The impact on transfusion requirements between both groups is evaluate on the following items :
|
| At the end of the study, an average of 1 month |
| Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity | The impact on Hospital morbidity between both groups is evaluate on the following complications :
| At the end of the study, an average of 1 month |
| Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality | Comparison on the number of deaths in each group. | At the end of the study, an average of 1 month |
| Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management | The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Complications of the supine position (bedsores, etc.) and those related to the field (confusion, physical restraint indwelling catheter, stay in intensive care, resumption walking /chair, delay in returning home, Follow-up care and rehabilitation (SSR), geriatric assessment, nutritional management) | At the end of the study, an average of 1 month |
| Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management | The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Degree of dependence according to the Katz evaluation scale, The KATZ scale is used to determine the degree of dependency of patients. It consists of a questionnaire assessing their abilities in 6 areas of daily life. For each area, the response varies between 4 scores ranging from no assistance to the need for total assistance. | At the end of the study, an average of 1 month |
| Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the factors affecting surgical management | The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Day of admission to care (weekend/holiday/on-call day) | At the end of the study, an average of 1 month |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided