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

Completed

• Conditions: Femur Fracture
• Interventions: Procedure: Standard Department procedure for managing direct-acting oral anticoagulants; Procedure: New Department procedure for managing direct-acting oral anticoagulants

• Registration Number: NCT06220422
• Lead Sponsor: Hôpital NOVO

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.

Study Timeline

• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-24
• Study Start: 2024-02-26
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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	At the end of the study, an average of 1 month	Comparison of time from hospital admission to surgery (in hours) between both groups

Secondary Outcome Measures

Name	Time	Method
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity	At the end of the study, an average of 1 month	The impact on Hospital morbidity between both groups is evaluate on the following complications : * Infectious complications (surgical site infection, nosocomial infections: urinary, pneumonia, others),; * Thromboembolic complications (pulmonary embolism, deep vein thrombosis),; * Cardiovascular complications (decompensation of heart failure, Acute pulmonary oedema, ACS),; * Post-operative haemorrhagic complications (surgical site haematoma requiring treatment),; * 30-day readmission
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the factors affecting surgical management	At the end of the study, an average of 1 month	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)
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss	At the end of the study, an average of 1 month	Comparison on the amount of blood lost (mL) between both groups
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management	At the end of the study, an average of 1 month	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)
Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement	At the end of the study, an average of 1 month	The impact on transfusion requirements between both groups is evaluate on the following items : * Packed red blood cells,; * Fresh frozen plasma,; * Unit concentrate of platelets,; * 4-factor prothrombin complex concentrate.
Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality	At the end of the study, an average of 1 month	Comparison on the number of deaths in each group.
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management	At the end of the study, an average of 1 month	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.

Trial Locations

Locations (1)

Anaesthetics department - Hôpital NOVO - Pontoise Site; 🇫🇷 Pontoise, France